louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03220568: Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort
Official title: Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 57053
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 1993 and 1997, a total of 57,053 men and women were recruited. At the time of invitation, they were 50 to 64 years old, born in Denmark, residing in the urban and suburban areas of Copenhagen and Aarhus and had not been registered with a cancer diagnosis in the Danish Cancer Registry.

Brief summary: Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.

Objective: Therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.

Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health cohort, including all incident stroke cases and a random sample of the total cohort.The fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. Stroke cases were identified in the Danish National Patient Registry and the diagnoses were individually verified. Cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.


Eligibility criteria: Inclusion Criteria: Born in Denmark, aged 50-64 years, residing in the urban and suburban areas of Copenhagen and Aarhus, Denmark.

-

Exclusion Criteria: Pre-existing cancer diagnosis. Previous stroke.

-

Primary outcomes:
measure: Stroke, including validated subtypes
timeFrame: From baseline until 30 November 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00108368: The Effects of Risperidone and Olanzapine on Thinking
Official title: The Cognitive Effects of Risperidone and Olanzapine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychotic Disorders
Keywords: schizophrenia
cognition
antipsychotic medication
information processing
social cognition
Psychotic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Janssen, LP
First posted: 2005-04-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition.

Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with schizophrenia disorder by a DSM IV.
* Competent to sign informed consent
* No history of poor response to Risperdal and Zyprexa
* No organic brain disease

Exclusion Criteria:

* Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
References:
citation: Sergi M, Green M, Widmark C, Reist C, Erhart S, Braff D, Kee K, Marder S, Mintz J. Social Cognition and Neurocognition: Effects of Risperidone, Olanzapine, and Haloperidol. Am J Psychiatry. 2007 Oct 1;164(10):1585-1592. doi: 10.1176/appi.ajp.2007.06091515.
citation: Sergi MJ, Green MF, Widmark C, Reist C, Erhart S, Braff DL, Kee KS, Marder SR, Mintz J. Social cognition [corrected] and neurocognition: effects of risperidone, olanzapine, and haloperidol. Am J Psychiatry. 2007 Oct;164(10):1585-92. doi: 10.1176/appi.ajp.2007.06091515.
Clinical trial NCT03990168: The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
Official title: The Effect of the Combined Treatment Approach of Delayed Auditory Feedback and Transcranial Direct Current Stimulation to Enhancement of Speech Fluency in Adults Who Stutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stuttering/ Developmental
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere \[mA\] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.


Eligibility criteria: Inclusion Criteria:

* History of developmental stuttering
* Participants diagnosed with moderate to severe stuttering
* Right handed
* Native speaker of Farsi

Exclusion Criteria:

* Speech or language disorders other than stuttering
* Received stuttering treatment within the past year
* Hearing loss
* History of neurological or psychiatric disorders
* History of seizure
* Taking any medication that may affect brain function such as anti-depressants

Primary outcomes:
measure: Mean score of percentage of Stuttered Syllables produced in the speech sample
timeFrame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Secondary outcomes:
measure: Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
timeFrame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
measure: Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)
timeFrame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Narges Moin
Study officials:
affiliation: Iran University of Medical Sciences
name: Reyhane Mohamadi
role: STUDY_DIRECTOR
References:
citation: Moein N, Mohamadi R, Rostami R, Nitsche M, Zomorrodi R, Ostadi A, Keshtkar A. Delayed Auditory Feedback and Transcranial Direct Current Stimulation Treatment for the Enhancement of Speech Fluency in Adults Who Stutter: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 21;9(4):e16646. doi: 10.2196/16646.
Clinical trial NCT06295068: Evaluation of ARi With OpSens SavvyWire
Official title: Evaluation of the Aortic Regurgitation Index (ARi) Measured With the Opsens SavvyWire to Determine the Correlation Between Regurgitation Evaluation Using Echography and Aortography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Insufficiency
Lead sponsor: Opsens, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 13
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: Subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention

Brief summary: The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE
* Age \> 18 years
* Able and willing to give informed consent.

Exclusion Criteria:

* Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely
* Subject is considered part of a vulnerable population.

Primary outcomes:
measure: Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography
timeFrame: From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours
Secondary outcomes:
measure: Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography
timeFrame: From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours
measure: Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography
timeFrame: From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours
Other outcomes:
Locations:
city: Morristown
country: United States
facility: AHS Morristown Medical Center
state: New Jersey
Study officials:
affiliation: AHS Morristown Medical Center
name: Philippe Généreux, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997568: Safety of the PET-511BTM Transesophageal Transducer
Official title: Safety of the PET-511BTM Transesophageal Transducer (TEE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Requiring TEE Procedure by Their Physician
Keywords: transesophageal
transducer
TEE
Lead sponsor: Toshiba America Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been scheduled for a TEE procedure by their physician.

Brief summary: The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.

Detailed description: The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.

Eligibility criteria: Inclusion Criteria:

* Male and female patients between the ages of 20 and 80
* Informed consent understood and signed
* Compliance with post-treatment follow-up protocol requirements

Exclusion Criteria:

* None

Primary outcomes:
measure: The TEE transducer passes safely into the esophagus.
timeFrame: during, 30 minutes, and 24 hours after the exam
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: The Christ Hospital
name: Gregory B. Clarke, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Health
name: David Rubensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01932268: A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Tuberculosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.


Eligibility criteria: Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking rifampicine over 2weeks
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* the patient have hypersensitivity to colchicine
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* uncontrolled hypertension
* serum albumin \< 3.5, \> 5 g/dL
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding

Primary outcomes:
measure: a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
timeFrame: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06070168: Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
Official title: Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of telephone counseling services provided to primiparous mothers on postpartum depression.

Hypotheses H01; there is no difference between the postpartum depression score of the telephone counseling services group and the postpartum depression score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the women who give birth will be visited by the researcher at the postpartum clinic at least 6 hours after normal birth and 12 hours after cesarean births.

After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

The researcher will contact the experimental group by phone. He will introduce herself and 6 weeks (during postpartum). It will provide the mother with the consultancy service she needs about herself and the newborn 24 hours a day. After 6 weeks, the training will end and the third researcher will make post-tests of the depression scale to both groups without knowing the experimental and control groups.


Eligibility criteria: Inclusion Criteria:

* primiparous women
* Agreeing to participate in the research and obtaining written permission,
* No hearing or vision problems

Exclusion Criteria:

* multiparous women

Primary outcomes:
measure: Change in postpartum depression
timeFrame: immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
References:
Clinical trial NCT02262468: Warwick Metal On Metal Study
Official title: Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metal Hip Replacement
Keywords: retrospective analysis
Lead sponsor: South Warwickshire NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: DePuy International
First posted: 2014-10-13
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with 36mm metal on metal hips

Brief summary: assess results of metal on metal hip replacements carried out at warwick hospital

Detailed description: Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.

Eligibility criteria: Inclusion Criteria:

* All patients with 36mm metal on metal hips

Exclusion Criteria:

-

Primary outcomes:
measure: Oxford hip score
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01230268: A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
Official title: A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: C3G
Oxidative stress
Antioxidant
Mulberry
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Rural Development Administration, Korea
First posted: 2010-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract.

This study, as an exploratory trial, does not required statistical hypothesis.


Eligibility criteria: Inclusion Criteria:

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight)
* Give written informed consent and voluntarily decide participation

Exclusion Criteria:

* Acute or chronic disease symptom on screening
* Existing active and clinically significant disease involving more than one organ system
* Known allergy to Mulberry or other berries
* Positive drug or alcohol screening
* Smokers of 10 or more cigarettes per day
* Participation in a clinical trial during last 2 month prior to the start of the study
* Pregnancy

Primary outcomes:
measure: Cmax - Maximum Observed Concentration - C3G in Plasma
timeFrame: Blood samples collected over 6 hours
measure: AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
timeFrame: Blood samples collected over 6 hours
measure: Antioxidative markers
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: for 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Dong-Seok Yim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02393768: Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis
Official title: Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Canisius-Wilhelmina Hospital
First posted: 2015-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients \>18 years who have underwent CCTa scanning beacuse of chest pain.

Brief summary: In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

Detailed description: Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. We hypothesize that trained monocytes augment atherogenesis.

Objective: The main objective is to study whether patients with coronary atherosclerosis show specific epigenetic changes in the promoter regions of pro-inflammatory cytokines and chemokines and whether this correlates with the inflammatory phenotype of these cells.

Study design: Observational study

Study population: Adult patients who have had computed tomography coronary angiography because of chest pain: 20 patients without atherosclerosis and 20 patients with severe atherosclerosis will be included.

Eligibility criteria: Inclusion Criteria:

* Patients (male/female),
* aged \>18 years,
* admitted to the acute coronary unit of the CWZ hospital for evaluation of chest pain.
* No coronary atherosclerosis
* Or Severe atherosclerosis

Exclusion Criteria:

* Signs or symptoms of a current infection (fever, chills)
* Auto-immune diseases (such as rheumatoid arthritis)

Primary outcomes:
measure: Epigenetic modifications in circulating monocytes
timeFrame: baseline
Secondary outcomes:
measure: Inflammatory phenotype
timeFrame: baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
References: