louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01947179: Cognitive Anxiety Sensitivity Treatment for Suicide
Official title: Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-09-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.

Detailed description: CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment.

Eligibility criteria: Inclusion Criteria:

* At or above the community sample mean on the ASI
* English speakers
* 18 years of age or older

Exclusion Criteria:

* Significant medical illness
* Current substance dependence
* Current or past psychotic-spectrum disorders
* Uncontrolled bipolar disorder
* Serious suicidal intent that warranted immediate medical treatment

Primary outcomes:
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Month one follow-up
Secondary outcomes:
measure: Beck Suicide Scale (BSS)
timeFrame: Month one follow-up
Other outcomes:
measure: Posttraumatic Diagnostic Scale (PDS)
timeFrame: Month one follow-up
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT02110979: Validation of a Patient Decision Aid for Type 2 Diabetes
Official title: Validation of a Patient Decision Aid for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Patient Decision Aid
Shared Decision Making
Lead sponsor: EPI-Q
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.

Detailed description: This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Age 18 or older
3. English speaking
4. Currently taking metformin
5. Inadequate glycemic control in the opinion of the investigator
6. Is considering additional medication options on the advice of their physician
7. Can provide a valid email address
8. Access to the internet and able to read and respond to internet questionnaires

Exclusion Criteria:

1. Participation in a clinical trial of a diabetes medication within 1 year
2. Currently taking more than two (2) medications for diabetes
3. Has been exposed to diabetes medications from more than three (3) drug classes
4. Adults unable to consent
5. Individuals who are not yet adults (infants, children, teenagers)
6. Pregnant women
7. Prisoners

Primary outcomes:
measure: Knowledge score
timeFrame: 6 weeks
Secondary outcomes:
measure: Decisional conflict
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oak Brook
country: United States
facility: EPI-Q Inc
state: Illinois
city: Oak Brook
country: United States
facility: EPI-Q
state: Illinois
Study officials:
affiliation: EPI-Q
name: Alicia Shillington, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.
Clinical trial NCT00846079: Myocardial Perfusion Assessment With Multidetector Computed Tomography
Official title: Myocardial Perfusion Assessment With Multidetector Computed Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
stress testing
Lead sponsor: Tennessee Heart and Vascular Institute, P.C.
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2009-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years of age
* Adults undergoing myocardial perfusion SPECT imaging
* Adults with suspected coronary artery disease

Exclusion Criteria:

* Age \<18
* Known or suspected renal insufficiency (Creatinine \<1.7 mg/dl)
* Allergy to contrast
* Inability or contraindication to lexiscan or beta blocker

Primary outcomes:
measure: Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
timeFrame: 6 months
Secondary outcomes:
measure: Radiation dosimetry
timeFrame: 6 months
Other outcomes:
Locations:
city: Hendersonville
country: United States
facility: Tennessee Heart and Vascular Institute
state: Tennessee
Study officials:
References:
Clinical trial NCT04739579: Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.
Official title: Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn Disease
Anastomotic Leak
C-Reactive Protein
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ileocolic resection with primary anastomosis

Brief summary: Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.


Eligibility criteria: Inclusion Criteria:

* Crohn's disease patients
* Primary ileocolic anastomosis
* C-Reactive Protein data available in medical file

Exclusion Criteria:

* Protective stoma
* Associated resection with or without anastomosis during intervention

Primary outcomes:
measure: Anastomotic leak
timeFrame: up to 30 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Adeline Germain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03752879: The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery
Official title: The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Complication
Avulsion
Keywords: Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 86
Sex: FEMALE
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: Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.

Brief summary: We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.

Detailed description: We will recruit women immediately following their first vaginal delivery. Women who underwent Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure) will be recruit matched by BMI, second stage duration and birthweight. All women will be invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases and controls.

Eligibility criteria: Inclusion Criteria:

* First delivery
* Term pregnancy (37-41w)

Exclusion Criteria:

* Instrumental vaginal delivery
* Multifetal pregnancy
* Previous vaginal or cesarean delivery
* Refused consent and uncooperative patient for effective Valsalva maneuver
* Handicap in lithotomy position
* Women without regular and active contractions
* Epidural analgesia

Primary outcomes:
measure: levator ani muscle (LAM) injury
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital
Study officials:
References:
citation: Takmaz T, Aydin S, Gorchiyeva I, Karasu AFG. The usual suspect: cross-sectional study of fundal pressure at second stage of delivery and the association with pelvic floor damage. Int Urogynecol J. 2021 Jul;32(7):1917-1924. doi: 10.1007/s00192-020-04523-x. Epub 2020 Sep 9.
Clinical trial NCT04573179: Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3
Official title: Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 60
Sex: MALE
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: community residents

Brief summary: The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.


Eligibility criteria: Inclusion Criteria:

* males over 18 years old suspected for prostate cancer
* serum PSA between 4ng/ml and 20ng/ml in recent two months
* mpMRI PI-RADS version2 scores 3 in recent two months
* willing to undertake prostate biopsy
* no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride)
* ECOG 0-1

Exclusion Criteria:

* history of prostate biopsy or other operations
* history of prostate cancer associated treatment
* contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min)
* not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)

Primary outcomes:
measure: detection rate
timeFrame: one year
Secondary outcomes:
measure: detection rate
timeFrame: one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00457379: Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study)
Official title: Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
HDL-Cholesterol
Endothelial Function
Endothelial Progenitor Cells
normal blood HDL-Cholesterol level
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties.

The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease
* Normal HDL-cholesterol levels in blood:

  * \> 40 mg/dl (1.03 mmol/L) in males
  * \> 50 mg/dl (1.29 mmol/L) in females

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Acute coronary syndrome
* Unstable angina pectoris
* Myocardial infarction during the last 8 weeks
* Therapy with niacin
* Active infections
* Ventricular arrhythmias
* Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg
* Cancer
* Pregnant or lactating
* Alcoholism

Primary outcomes:
measure: vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training
Secondary outcomes:
measure: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Helmut Drexler, MD
role: STUDY_DIRECTOR
affiliation: Hannover Medical School
name: Ulf Landmesser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Kristina Sonnenschein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662779: Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Official title: Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Exercise-induced Bronchospasm
Keywords: asthma
exercise induced bronchospasm
prevention
EIB
children
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.

Detailed description: This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.

Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.

Eligibility criteria: Inclusion Criteria:

* Children 12-17 years of age
* Physician diagnosed asthma for at least 6 months
* Long term controller medication for at least 4 weeks if any being used
* Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
* EIB diagnosed by a positive exercise challenge at screening
* Forced expiratory volume in 1 second (FEV1) greater than 70% of predicted at screening visit

Exclusion Criteria:

* History of cardiac dysfunction
* Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
* Upper respiratory infection in the last 4 weeks
* Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
* Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
* Pregnancy or lactation
* History of paradoxical bronchospasm with any beta-agonist
* Obesity defined as BMI greater than 30 kg/m2

Primary outcomes:
measure: It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
timeFrame: April 2008-April 2010
Secondary outcomes:
measure: Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
timeFrame: April 2008- April 2010
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico- Pediatric department
name: Hengameh Raissy, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198679: Effect of Chlorhexidine Skin Cleansing on Skin Flora
Official title: Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Infectious
Keywords: skin cleansing
Bangladesh
Skin Flora
Newborn
infectious disease
chlorhexidine
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 210
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

Detailed description: This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.

Eligibility criteria: Inclusion Criteria:

* Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
* parental consent must be obtained

Exclusion Criteria:

* infants being admitted for major surgical procedure which is attended by high rate of infectious complications
* sepsis
* clinically-evident skin infection
* generalized skin disease
* structural defect of the skin involving greater than 5% of the body surface
* with a major congenital anomaly
* with a known immunodeficiency

Primary outcomes:
measure: Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Shishu Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Gary Darmstadt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02974179: A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Official title: A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: AnGes USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.

Brief summary: Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

Detailed description: The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

Eligibility criteria: Inclusion Criteria:

* Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
* Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have provided a release of information to the sponsor.

Exclusion Criteria:

* Subjects who were not enrolled in the AGCLI-0206 study.
* Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.
* Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

Primary outcomes:
measure: Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001
timeFrame: 3 years from the date last subject randomized into AG-CLI-0206 study
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard Powell, MD
role: PRINCIPAL_INVESTIGATOR
References: