louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01312116: Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder
Official title: Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Internet treatment
GAD
guided self-help
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Stockholm University
First posted: 2011-03-10
Enrollment: 81
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: The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.

Detailed description: This was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in Sweden. Outcome assessors were blind to treatment status.

Eligibility criteria: Inclusion Criteria:

* fulfill the diagnostic criteria for GAD according to DSM-IV
* have access to the Internet
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation

Primary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Two weeks pre treatment to two weeks post treatment.
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: Quality of Life Inventory (QOLI)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: Beck Depression Inventory (BDI)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: Beck Anxiety Inventory (BAI)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Two weeks pre treatment to two weeks post treatment
measure: Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)
timeFrame: Two weeks pre treatment to two weeks post treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02596516: A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies
Official title: A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colectomy
Bile Acid and Salts
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients palnned to undergo colon resection.

Brief summary: The aim of this study is to evaluate whether there is a difference in the bile acid content in the bowel in patients after right versus left colectomy. There is compelling evidence that patients under going resection of the right colon versus left coolon have a lower polyp detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of patients undergoing left and right colectomies; prior to their surgery and again three and six months aftet the surgery. The investigators plan to compare the content of the different bile acids and to compare the content between the two groups.


Eligibility criteria: Inclusion Criteria:

* Age above 18.
* Patients intended to undergo a colectomy for colonic cancer
* Patients willing and participate and able to sign an informed consent

Exclusion Criteria:

* Age under 18.
* Patients with Inflammatory Bowel Disease (Crohn's, Ulcerative colitis).
* Patients refusing to participate or are unable to understand or sign an informed consent

Primary outcomes:
measure: Colonic bile acid content
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04859816: Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
Official title: Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Keywords: fat
triglyceride
triacylglycerol
Roux-en-Y gastric bypass
malabsorption
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.


Eligibility criteria: Inclusion criteria, RYGB

* Age \> 18 years
* RYGB \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Inclusion criteria, CON

* Age \> 18 years
* No former bariatric surgery
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1, and no history of diabetes

Exclusion criteria

* Thyrotoxicosis or inadequately treated hypothyreosis
* Haemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding
* Medication affecting the planned examinations which cannot be paused during the study period.
* Adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet)
* Complications restricting eating behavior (e.g. postprandial hypoglycemia, vomiting or strictures)
* MR contraindications

Primary outcomes:
measure: Area under the curve of plasma triacylglycerol
timeFrame: 6 hours
Secondary outcomes:
measure: Recovery of oral stable triacylglycerol isotope tracer in feces
timeFrame: 4 days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References:
Clinical trial NCT05869916: The Effect of Psychological First Aid Intervention on Stress and Resilience in Volunteers Working in Kahramanmaraş Centered Earthquakes
Official title: The Effect of Psychological First Aid Intervention on Stress and Resilience in Volunteers Working in Kahramanmaraş Centered Earthquakes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Resilience
Stress
Earthquake
Keywords: post traumatic stress disorder
psychological first aid
psychological resilience
earthquake victims
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a single-blind randomized controlled experimental study to determine the effect of online psychological first aid intervention on the stress and resilience levels of volunteers who took part in the earthquake.
Primary purpose: PREVENTION

Brief summary: Purpose: It was aimed to compare the effectiveness of online psychological first aid intervention on stress and psychological resilience in volunteers who took part in earthquakes.

Method: This is a single-blind randomized controlled experimental study conducted to determine the effect of online psychological first aid intervention on the stress and resilience levels of volunteers who took part in the earthquake.

Detailed description: In this study, it is aimed to compare the effectiveness of the online psychological first aid intervention on stress and psychological resilience given to the volunteers working in various provinces (11 provinces) affected by the Kahramanmaraş Centered Earthquakes.

Eligibility criteria: Inclusion Criteria:

* Volunteering in the earthquake zone,
* Not having a perception disorder that will prevent communication,
* To volunteer to participate in the research.

Exclusion Criteria:

* Having a communication barrier,
* Not wanting to be involved in the study.

Primary outcomes:
measure: 1st hypothesis
timeFrame: 2 weeks
measure: 2nd hypothesis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: The data of the study were collected between February 20, 2023 and March 20, 2023 in the form of group interviews by applying online psychological first aid to volunteers working in Kahramanmaraş Centered Earthquakes that occurred in Turkey on Monday, Feb
Study officials:
affiliation: galipusta@trabzon.edu.tr
name: galip usta, 2
role: STUDY_DIRECTOR
affiliation: kemaltorpus@artvin.edu.tr
name: kemal torpuş, 3
role: STUDY_DIRECTOR
References:
Clinical trial NCT00880516: Genetic Factors in Chronic Sinusitis
Official title: Genetic Factors in Chronic Sinusitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Sinusitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with and without chronic sinusitis

Brief summary: The purpose of this study is to learn more about the genetics of chronic sinusitis and identify genes involved in chronic sinusitis.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Diagnosis of chronic sinusitis or normal sinuses (with verification by imaging.) You must have a recent CT scan showing either normal sinuses or the presence of sinus disease.

Exclusion Criteria:

* Genetic or acquired immunodeficiency
* Ciliary dyskinesia
* Cystic fibrosis
* Autoimmune disease
* Cancer of the sinuses

Primary outcomes:
measure: Association of genetic variation with CRS disease status
timeFrame: Adult age
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jayant Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773916: The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder
Attention Deficit Disorders with Hyperactivity
Hyperkinetic Syndrome
Family Function
Adverse Factors
Parental Psychopathology
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Hospital de Clinicas de Porto Alegre
First posted: 2008-10-16
Enrollment: 130
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

Detailed description: Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in many aspects of the patient´s life, such as academic achievements, peers relationships and physical injuries. There are few studies assessing predictive factors of clinical response to treatment. Different patterns of family functioning, such as high family conflict and low family cohesion might be associated with a poor treatment response, possibly mediating the effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental psychopathology has been associated with a poorer prognosis and is related with family functioning. Adverse social factors have long been studied and are associated with an increased risk for general mental disease, including ADHD, as well as a poorer prognosis. Different genetic factors have been studied and associated with different aspects of the disorder and different clinical responses to treatments. There are no studies evaluating how those factors interact with each other in a Brazilian population.

Eligibility criteria: Inclusion Criteria:

* ADHD
* Age: 5 - 18
* Primary Indication of Methylphenidate

Exclusion Criteria:

* IQ \< 70
* Clinical conditions that preclude use of methylphenidate

Primary outcomes:
measure: SNAP -IV scores
timeFrame: 1, 2, 3 and 6 months of treatment
measure: CGI scores
timeFrame: 1, 2, 3 and 6 months of treatment
Secondary outcomes:
measure: Scores in CGAS
timeFrame: 1, 2, 3 and 6 months of treatment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Luis A Rohde, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083716: A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
Official title: A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.


Eligibility criteria: Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
2. Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Area under the plasma concentration time curve (AUC) of ABI-H2158: Relative Bioavailability and Food Effect
timeFrame: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
measure: Maximum observed plasma concentration (Cmax) of ABI-H2158: Relative Bioavailability and Food Effect
timeFrame: before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Assembly Biosciences
name: Marc Evanchik
role: STUDY_DIRECTOR
References:
Clinical trial NCT02375516: Preventing Drug Abuse Among Hispanic Adolescents
Official title: Drug Abuse Prevention Programming for Hispanic Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Keywords: Drug abuse
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-03-02
Enrollment: 678
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The planned research aims to delay the onset of drug use and reduce harmful use and abuse among Hispanic youths. The culturally-tailored prevention program will be delivered to youths by computer. Over 5 years, the program will be developed and tested in a randomized clinical trial. The intervention program will include 10 initial sessions, followed by annual booster sessions. Outcome measurements will involve baseline, post-intervention, and three annual follow-up data collections.

The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among participants assigned to receive the intervention. If proven to be efficacious, the program will be revised and disseminated nationally.

Detailed description: America's largest ethnic minority group, Hispanics are also a youthful population: one-third of Hispanic Americans are less than 18 years old. Unfortunately, young Hispanic Americans are an at-risk population more likely than their majority culture peers to drop out of school, become involved in the criminal justice system, fall prey to violence, and face lifelong economic problems. Hispanic youths are also at risk for early drug use and subsequent harmful use and abuse. As early as eighth grade and relative to their Black and White peers, Hispanic adolescents report higher rates of most harmful substances. Drug use continues to pose problems for Hispanic youths throughout adolescence and into adulthood.

Eligibility criteria: Inclusion Criteria:

* 12 to 15 years old
* Hispanic ethnicity

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in average number of drug abuse instances
timeFrame: Baseline, Post-intervention, Year 1, Year 2, Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Traci Schwinn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schinke SP, Schwinn TM, Hursh HA. Preventing Drug Abuse Among Hispanic Adolescents: Developing a Responsive Intervention Approach. Res Soc Work Pract. 2015 Oct;25(7):794-800. doi: 10.1177/1049731514538103. Epub 2014 Jul 1.
citation: Schwinn TM, Schinke SP, Hopkins J, Thom B. Risk and protective factors associated with adolescent girls' substance use: Data from a nationwide Facebook sample. Subst Abus. 2016 Oct-Dec;37(4):564-570. doi: 10.1080/08897077.2016.1154495. Epub 2016 Sep 20.
Clinical trial NCT01764516: Study on Serum Zinc and Selenium Levels in Epileptic Patients
Official title: Arak University of Medical Sciences , Ministry of Health and Education,I.R.Iran
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Generalized Epileptic
Keywords: zinc
selenium
serum
epilepsy
antioxidants
Lead sponsor: Arak University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all generalized and single epileptic patiants which were identify for fist time

Brief summary: This study was carried out with the purpose of evaluating zinc and selenium levels in serum of epileptic patients and compare with normal individuals.

Detailed description: Forty patients aged 18 to 50 years visiting Vali-Asr hospital in Arak, I.R. Iran, who were diagnosed with generalized form of epilepsy by a neurologist for the first time were recruited as cases. The control group (n=40) was selected from healthy individuals, in whom no disease was diagnosed until this study, and were matched to the case group by age, sex, and economical status.

Eligibility criteria: Inclusion Criteria:

New generalized and single epileptic cases patients who accept and sign the approval form of ethical committee non smoker, no trauma, no use of selenium supplement, no use of zinc supplement, no use of vitamin A supplement, no use of vitamin D supplement, no Weight loss, no Diarrhea, no addiction, no alcohol consumption, no use of certain medications,

Exclusion Criteria:

presence of above criteria as well as, generalized and single epileptic cases under treatment

Primary outcomes:
measure: Study on Serum Zinc and Selenium Levels in Epileptic Patients
timeFrame: 5 months
Secondary outcomes:
measure: Comparison between the selenium levels by gender in two groups
timeFrame: 5 months
Other outcomes:
Locations:
city: Arak
country: Iran, Islamic Republic of
facility: Vali-Asr Hospital
state: Central province
Study officials:
affiliation: Department of Biochemistry,Arak medical sciences university
name: Heidar N Farahani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216616: Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
Official title: Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Inflammatory Rheumatism
Keywords: fatigue
Inflammatory Rheumatism
Coping
self-efficacy
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
name: Norsk revmatikerforbund
First posted: 2017-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fatigue is common and debilitating in rheumatic inflammatory diseases as for other chronical medical conditions. The purpose of this study is to develope and evaluate a cognitive behavioural intervention targeting fatigue. The aim of the intervention is to improve fatigue self-management by changing behavioral and cognitive factors contributing to perceived fatigue. Levels of fatigue, depressive symptoms and self esteem will be measured before, after and three months after the intervention.


Eligibility criteria: Inclusion Criteria:

• Men and women over 18 years with inflammatory rheumatic diseases and fatigue at Department of Rheumatology, Diakonhjemmet Hospital

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and understand Norwegian
* Unable to complete a survey

Primary outcomes:
measure: Screening of the perceived level of fatigue in patients with inflammatory rheumatic disease
timeFrame: 2-10 minutes
measure: Screening of depressive symptoms in patients with inflammatory rheumatic disease and fatigue
timeFrame: 2-10 minutes
measure: Screening of the patients perceived self efficacy in coping with fatigue
timeFrame: 10-15 minutes
measure: Reduce perceived fatigue and increase perceived self efficacy in relation to coping with fatigue in patients with inflammatory rheumatic diseases
timeFrame: 6 weeks-6 months
measure: Detection of changes in perceived levels of fatigue
timeFrame: 2-10 minutes
measure: Detection of changes in symptoms of depression
timeFrame: 2-10 minutes
measure: Detection of changes in the patients perceived self efficacy in coping with fatigue
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: