louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01988974: Feasibility Testing of the Alert for Atrial Fibrillation Program
Official title: Feasibility Testing of the Alert for Atrial Fibrillation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical, practical knowledge about the feasibility of conducting a randomized trial to test the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial Fibrillation (AF).

Detailed description: The purpose of the proposed research is to evaluate the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS), which is an instrument designed to tailor the delivery of the Alert for Atrial Fibrillation program. The proposed research will also test the feasibility of studying the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of AF in a larger, randomized trial. This research is significant, because current research suggests that treatment seeking for AF is hindered when people do not recognize symptoms that represent AF, attribute those symptoms to alternative causes, or do not believe symptoms are serious enough to require medical evaluation. Interventions tailored to modify patient-specific knowledge, attitudes, and beliefs that hinder early treatment-seeking are critically needed in order to improve early detection of AF. The long term goal of this research is to improve health outcomes of those at risk for developing AF.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older
* Under the care of providers from the Department of Medicine
* English-speaking
* Community dwelling,
* Have access to and ability to communicate via a telephone
* Have one or more risks for developing AF
* Not be diagnosed with AF

Exclusion Criteria:

* Documented cognitive impairment
* Uncompensated hearing or visual deficits
* Scheduled for surgery or have undergone a surgical procedure in the last 30 days,
* Undergoing active treatment for a malignancy
* Receiving hospice care will be excluded

Primary outcomes:
measure: Changes on the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey
timeFrame: Baseline, One Month, Two Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Pamela J McCabe, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03339674: Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment
Official title: Sub-Project No 8 of the Research Group RISKDYNAMICS: Addiction Risk - the Dynamic of Risk Perception and Risk Behavior in Alcohol Dependence, Work Package 1, Study 1.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Centre for Psychiatry Reichenau, Germany
First posted: 2017-11-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on previous research (Odenwald \& Semrau, 2012) the investigators know that psychoeducation on comorbid mental disorders during residential alcohol detoxification can improve subsequent treatment utilization. In this study they will study a hypothesized psychological mechanism that contributes to this behavior change.

The investigators will recruit alcohol dependent patients in residential detox treatment who all receive Treatment as Usual. Participants will be randomly assigned to an additional psychoeducational group therapy (intervention group) or to an additional neuropsychological group training (control group). Measurements will take place on the day before study inclusion, one week later and one month after release from index residential treatment. Measurements will include alcohol-related risk perception, alcohol use, treatment motivation, comorbid psychiatric symptoms and whether the patient has regularly completed treatment and whether he/she has been transferred to subsequent treatment. Furthermore, six months after release from index treatment information on re-admission to the clinic is assessed from patient files.

The investigators hypothesize that the behavioral effects of psychoeducational group intervention will be mediated by adaptive changes of the individual's alcohol-related risk perception.


Eligibility criteria: Inclusion Criteria:

* Alcohol Dependence (according to ICD-10)

Exclusion Criteria:

* treatment episode is acute crisis intervention
* acute psychosis
* acute suicidality
* no command of German language (reading writing)

Primary outcomes:
measure: Questionnaire on Alcohol-related Risk Perception
timeFrame: one week
Secondary outcomes:
measure: Treatment completion
timeFrame: One month after study completion
measure: Transfer to subsequent treatment
timeFrame: One month after study completion
measure: Alcohol relapse
timeFrame: four weeks
measure: Readmission to detox treatment
timeFrame: six months
Other outcomes:
Locations:
city: Reichenau
country: Germany
facility: Center for Psychiatry Reichenau
Study officials:
References:
citation: Odenwald M, Semrau P. Reducing dropout among traumatized alcohol patients in detoxification treatment: a pilot intervention study. Eur Addict Res. 2012;18(2):54-63. doi: 10.1159/000333336. Epub 2011 Dec 16.
Clinical trial NCT04929574: Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
Official title: Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Beta Thalassemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: ZhuHai Hospital
name: Shenzhen Children's Hospital
name: Shenzhen Second People's Hospital
name: Jiangmen Maternity and Child Health Care Hospital
name: Yongzhou Maternity and Child Health Hospital
First posted: 2021-06-18
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: beta thalassemia patients from Southern China

Brief summary: Heart failure from myocardial iron deposition is a severe complication for patients with transfusion-dependent beta thalassemia . Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.Echocardiogram is used as noninvasive method to observe heart status. The objective of this study is to evaluate the heart status in patients of Beta Thalassemia from southern China.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with beta-thalassemia

Exclusion Criteria:

* Iron deficiency anemia

Primary outcomes:
measure: Echocardiogram
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03923374: Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Official title: Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid-use Disorder
Opioid Use, Unspecified
Buprenorphine Dependence
Keywords: Pregnant with Opioid Use Disorder
Opioid Use Disorder ( OUD)
Subutex
Buprenorphine
Pregnant taking buprenorphine/subutex
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-04-22
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.

Brief summary: The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

Detailed description: One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.

Eligibility criteria: Inclusion Criteria:

* Age greater 18 years
* Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.
* Pregnant with single baby
* Planned delivery at Methodist, University or Riley Hospital

Exclusion Criteria:

* Serious maternal medical illness as deemed by study physician or investigator.
* Known or suspected major fetal/neonatal congenital abnormalities.

Primary outcomes:
measure: Incidence of opioid misuse severity using assessments
timeFrame: 5 years
measure: Pharmacological treatment for neonatal abstinence syndrome
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of adverse effects of buprenorphine using MRI
timeFrame: 5 years
measure: Concentration of long-term neurodevelopmental outcomes using assessments
timeFrame: 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, UPMC
name: Senthil Sadhasivam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267474: Reducing the Use of Sugar by School Lunch Cooks in Public Schools
Official title: Reducing the Use and the Consumption of Sugar by School Lunch Cooks in Public Schools: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sugar Intake
Keywords: School children
Sugar intake
Nutritional education program
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-12-28
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective was to evaluate the effect of a nutritional education program for school lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.

Detailed description: Although Brazil is the largest producer and one of the world's largest consumers of sugar, research on sugar consumption is still a weak point among health indicators and there are no population studies to investigate the sugar intake in Brazilian population. Available data have shown reduction in the consumption of refined sugar (-37% between 1996 and 2003) but significant increase in consumption of soft drinks (400%), which constitute the main vehicle for consumption of added sugar. Moreover, studies have shown the adverse effects of excessive consumption of added sugar in dental caries and health, as excess energy intake hence in weight gain. Although several factors are associated with weight gain in adolescents, adults and elders, and several strategies have been released by both Brazil and International Agencies, as the Global Strategy, increased weight gain, particularly in adolescents, has been observed in several countries with large increase in Brazil, justifying specific projects to evaluate which messages, strategies and proposals for intervention would be effective.

Eligibility criteria: Inclusion Criteria:

* Women who were working in the function of school lunch cook in the schools.

Exclusion Criteria:

* Pregnancy, male.

Primary outcomes:
measure: Sugar intake
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
affiliation: Rio de Janeiro State University
name: Rosely Sichieri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376674: T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer
Official title: Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: localised
prostate cancer
radiotherapy
immunology
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing standard radiotherapy for localised prostate cancer at the University Hospital of Tuebingen

Brief summary: Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner.

In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.


Eligibility criteria: Inclusion Criteria:

* Localised prostate cancer (node negative)
* definitive radiotherapy
* informed consent

Exclusion Criteria:

* medication including steroids or immunosuppressants

Primary outcomes:
measure: T-cell-immunity in time-course
timeFrame: During and 3-6 months after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Radiation Oncology
Study officials:
affiliation: University Hospital Tuebingen
name: Cihan Gani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Franziska Eckert, MD
role: STUDY_DIRECTOR
References:
citation: Widenmeyer M, Shebzukhov Y, Haen SP, Schmidt D, Clasen S, Boss A, Kuprash DV, Nedospasov SA, Stenzl A, Aebert H, Wernet D, Stevanovic S, Pereira PL, Rammensee HG, Gouttefangeas C. Analysis of tumor antigen-specific T cells and antibodies in cancer patients treated with radiofrequency ablation. Int J Cancer. 2011 Jun 1;128(11):2653-62. doi: 10.1002/ijc.25601. Epub 2010 Oct 8.
citation: Hoffmann E, Paulsen F, Schaedle P, Zips D, Gani C, Rammensee HG, Gouttefangeas C, Eckert F. Radiotherapy planning parameters correlate with changes in the peripheral immune status of patients undergoing curative radiotherapy for localized prostate cancer. Cancer Immunol Immunother. 2022 Mar;71(3):541-552. doi: 10.1007/s00262-021-03002-6. Epub 2021 Jul 16.
citation: Eckert F, Schaedle P, Zips D, Schmid-Horch B, Rammensee HG, Gani C, Gouttefangeas C. Impact of curative radiotherapy on the immune status of patients with localized prostate cancer. Oncoimmunology. 2018 Aug 27;7(11):e1496881. doi: 10.1080/2162402X.2018.1496881. eCollection 2018.
Clinical trial NCT01761474: CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols
Official title: Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction
Complication
Keywords: Carbon dioxide insufflation
Air insufflatioin
ERCP
Sedation
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study had an 80% power to detect a 20% difference in PAIN score any two groups, assuming 2-sided tests at a 5% significance level.Assuming a 10 % dropout rate, 220 patients were needed.

Brief summary: Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.


Eligibility criteria: Inclusion Criteria:

* candidates for therapeutic ERCP

Exclusion Criteria:

* age\<18 years
* pregnant women
* total gastrectomy
* uncontrolled coagulopathy
* American Society of Anesthesiologist(ASA) Class V
* neurologic impairment
* known allergy to the drugs used
* history of complications with previous sedation, sedative
* alcohol abuse
* inability to provide informed consent

Primary outcomes:
measure: Sedation quality
timeFrame: After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later
Secondary outcomes:
measure: Complications
timeFrame: After completion of procedures (within 2 hrs) and 24 hrs later
measure: Procedure outcome
timeFrame: After completion of procedure, within 2hrs
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungchungnam-do
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Tae Hoon Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578574: Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
Official title: Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2020-10-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.


Eligibility criteria: Inclusion Criteria:

1. Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
2. Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10).
3. Participants must be willing and able to sign informed consent

Exclusion Criteria:

1. Major psychiatric disease/disorder (self-reported)
2. A significant neurological trauma besides SCI
3. A recent (one-year) history of alcohol or drug abuse (selfreported)
4. Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures

Primary outcomes:
measure: Change in Neuropathic Pain Severity
timeFrame: baseline, up to two weeks
measure: Change in Performance of Body Part Processing
timeFrame: baseline, up to two weeks
Secondary outcomes:
measure: Change in Sensory Thresholds
timeFrame: baseline, up to two weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Eva Widerstrom-Noga, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02289274: Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203
Official title: Partial Replicated Crossover Clinical Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203 Treatment to Those of Co-administration of Eperisone Hydrochloride Slow Release and Aceclofenac in Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration of aceclofenac and eperisone HCl SR.

Detailed description: aceclofenac and eperisone(low back pain)

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 19 and 45
* BMI of \>19kg/m2 and \<28kg/m2 subject
* Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1

Primary outcomes:
measure: Area Under Curve(AUC) last
timeFrame: 0-24hr
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Asan Medical Center
name: Bae K Seop, M.D.
role: PRINCIPAL_INVESTIGATOR
References: