louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05996419: Intervention to Reduce Safety Behaviors
Official title: Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety
Keywords: Veteran
Social Anxiety
workforce
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Ralph H. Johnson VA Medical Center
First posted: 2023-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open trial
Primary purpose: OTHER

Brief summary: Social anxiety is associated with significant deficits in social and occupational functioning. The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Findings from this pilot will support a larger randomized controlled study examining the efficacy of the intervention for improving functional outcomes and quality of life among Veterans.


Eligibility criteria: Inclusion Criteria:

* Active enrollment in Compensated Work Therapy
* Score of \> 25 on the Social Phobia Inventory
* Score of \> 47 on the Subtle Avoidance Frequency Examination

Exclusion Criteria:

* Concurrent enrollment in another study related to social anxiety or improving functional status
* Recent (\<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt

Primary outcomes:
measure: Subtle Avoidance Frequency Examination (SAFE)
timeFrame: Baseline and immediately after intervention
measure: Social Phobia Inventory (SPIN)
timeFrame: baseline and immediately after intervention
Secondary outcomes:
Other outcomes:
measure: General Self-Efficacy Scale (GSE)
timeFrame: Baseline and immediately after intervention
measure: PTSD Checklist (PCL-5)
timeFrame: Baseline and immediately after intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and immediately after intervention
measure: Quality of Life Scale (QOL)
timeFrame: Baseline and immediately after intervention
measure: Rate of recruitment
timeFrame: 18 month (end of recruitment)
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)
timeFrame: Baseline and immediately after intervention
measure: Rate of retention
timeFrame: 18 month (end of recruitment)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline
measure: Reactions to the Intervention
timeFrame: immediately after intervention
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Anouk L. Grubaugh, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02777619: Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia
Official title: Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacodynamic Interaction
Keywords: Pharmacodynamic
Dexmedetomidine
Propofol
Target-controlled Infusion Intravenous Anesthesia
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).

Detailed description: 64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.

Eligibility criteria: Inclusion Criteria:

1. Weight:18≦ BMI≦25
2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

1. A previous history of intolerance to the study drug or related compounds and additives.
2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Primary outcomes:
measure: The EC50 of propofol for loss of consciousness
timeFrame: within 30 min during the induction of anesthesia
Secondary outcomes:
measure: The EC95 of propofol for loss of consciousness
timeFrame: within 30 min during the induction of anesthesia
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
citation: Chen Z, Shao DH, Hang LH. Effects of dexmedetomidine on performance of bispectral index as an indicator of loss of consciousness during propofol administration. Swiss Med Wkly. 2013 Mar 14;143:w13762. doi: 10.4414/smw.2013.13762. eCollection 2013.
citation: Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.
Clinical trial NCT01035619: Pediatric Pharmacokinetics And Safety Study Of Moxidectin
Official title: A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Onchocerciasis
Keywords: onchocerciasis; river blindness; moxidectin; pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: World Health Organization
First posted: 2009-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the amount of moxidectin in subjects' blood and to measure safety. This study will enroll 36 children aged 4 to 11 years (\>=12 kg) with or without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm, that causes Onchocerciasis, also known as river blindness. Each subject will receive a single dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening through day 13 and as outpatients through month 6. The study will take place at a single research center.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 4 to 11 years, inclusive (weighing \>= 12 kg)
* With or without O volvulus infection

Exclusion Criteria:

* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study
* Contraindication or hypersensitivity to moxidectin

Primary outcomes:
measure: The amount of moxidectin in subjects blood, as measured by collecting a number of blood samples from each subject, in which the amount of moxidectin will be measured
timeFrame: 3 months
Secondary outcomes:
measure: The safety and tolerability of a single dose of 4 mg moxidectin in subjects as measured by physical examinations, laboratory tests, vital signs and ECG findings
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00479219: Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients
Official title: A Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 in Blood and Cerebrospinal Fluid, When Administered Orally to Healthy Young Subjects and Patients With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).


Eligibility criteria: Inclusion Criteria:

* For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs.
* For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)

Primary outcomes:
measure: We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00666419: Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren
Official title: Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Low Back Pain
Keywords: nonspecific low back pain
schoolchildren
prevalence
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Universitat de les Illes Balears
First posted: 2008-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All 10-12 year old schoolchildren on the island of Mallorca, Spain

Brief summary: A large study in Mallorca, Spain showed that nonspecific low back pain is quite prevalent in adolescents 13-15 years of age (Kovacs, 2003). Since below the age of seven years hardly any child has suffered low back pain, the purpose of this study is to determine the prevalence of low back pain in children 10-12 years of age, and to investigate the risk factors associated with its occurrence.


Eligibility criteria: Inclusion Criteria:

* Schoolchildren born in the years 1993, 1994 or 1995
* Attending schools (public, concerted or private) in Mallorca
* Can read and write Spanish

Exclusion Criteria:

* Nor attending class on the days when the study is being done

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universitat de les Illes Balears, Palma de Mallorca, Spain
name: Pere Palou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balague F, Troussier B, Salminen JJ. Non-specific low back pain in children and adolescents: risk factors. Eur Spine J. 1999;8(6):429-38. doi: 10.1007/s005860050201.
citation: Kovacs FM, Gestoso M, Gil Del Real MT, Lopez J, Mufraggi N, Ignacio Mendez J. Risk factors for non-specific low back pain in schoolchildren and their parents: a population based study. Pain. 2003 Jun;103(3):259-268. doi: 10.1016/S0304-3959(02)00454-2.
citation: Gil del RealMT, Kovacs FM, Gestoso M, Mufraggi N, Diéguez JM. Evaluation of two questionnaires to determine exposure to risk factors for non-specific low back pain in Mallorcan schoolchildren and their parents. European Journal of Public Health 9(3): 194-199, 1999.
Clinical trial NCT06222619: Effect of PVE on Surgical Outcomes and Long-term Survival in Perihilar Cholangiocarcinoma
Official title: Effect of Portal Vein Embolization on Surgical Outcomes and Long-term Survival in Patients With Perihilar Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Cancer
Portal Vein Embolization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 136
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: Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma

Brief summary: Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV.


Eligibility criteria: Inclusion Criteria:

1. patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
2. patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.

Exclusion Criteria:

1. patients with unresectable perihilar cholangiocarcinoma
2. patients who refused treatment
3. patients with other concomitant malignancies.

Primary outcomes:
measure: Overall survival
timeFrame: The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months
Secondary outcomes:
measure: Recurrence free survival
timeFrame: The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01621919: Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1
Official title: Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who receiving S-1 as an adjuvant chemotherapy after radial surgery for gastric cancer

Brief summary: S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.

Detailed description: 1. S-1 metabolites concentration in plasma

   1. factors affecting plasma concentration

      * surgery subtype
      * serum creatinine
   2. systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration

      * enteritis
      * fatigue
2. S-1 metabolites concentration in tears

   1. correlation of tear concentration with plasma concentration
   2. lacrimal drainage obstruction caused by S-1 administration, and its correlation with tear S-1 metabolites concentration
   3. lacrimal drainage obstruction caused by S-1 administration, and its correlation with plasma S-1 metabolites concentration

Eligibility criteria: Inclusion Criteria:

* Patients who received radical surgery for gastric cancer
* Patients who receiving S-1 adjuvant chemotherapy
* Patients who administrated S-1 for more than 7 days

Exclusion Criteria:

* who using eyedrop medication
* who has dry eye that tear cannot be sampled

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: GYeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Keun-Wook Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01967719: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)
Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Nicotine absorption
Candidate modified risk tobacco product
Conventional cigarette
Nicotine replacement therapy: nasal spray
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 64
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).


Eligibility criteria: Inclusion Criteria:

* Subject is aged from 22 to 65 years (inclusive).
* Smoking, healthy subject as judged by the Investigator.
* Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
timeFrame: 3 days
measure: Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Central Kentucky Research Associates
name: James L Borders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123719: Laparoscopic Incisional Hernia Repair in Liver Transplant Patients
Official title: Outcomes Analysis of Laparoscopic Incisional Hernia Repair and Risk Factors for Hernia Recurrence in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with incisional hernia post liver transplantation

Brief summary: Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.

Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant.

Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate

- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values \<0.05 were considered significant.


Eligibility criteria: Inclusion Criteria:

* Incisional hernia
* Laparoscopic repair possible

Exclusion Criteria:

* Other types of ventral hernias
* Laparoscopy not possible

Primary outcomes:
measure: Hernia recurrence post laparoscopic incisional hernia repair
timeFrame: 1 - 74 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References:
Clinical trial NCT01781819: (ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
Official title: Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urine Reflux
Kidney Damage
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Urine reflux (urine backing up into the kidneys) is common in the pediatric population and may be complicated by renal abnormalities, such as infection and scarring. Currently, urine reflux is detected using either voiding cystourethrogram or other procedures. A new technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity imaging SVI) is performed using standard approved ultrasound machines and transducers bu the sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into the kidneys).


Eligibility criteria: Inclusion Criteria:

1. 18 years of age and younger
2. Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -

Exclusion Criteria:

None to list

Primary outcomes:
measure: Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Jonathan Dillman, MD
role: PRINCIPAL_INVESTIGATOR
References: