louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00086398: Psychotherapy Enhancement for Therapeutic Community (TC) Retention - 1
Official title: Psychotherapy Enhancement for TC Retention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents.

Detailed description: Therapeutic Community (TC) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. Personality disorders are very common in residential programs, and TCs regard personality disturbance as core to all people with addiction. Severe personality dysfunction is associated with higher dropout rates from TCs, and adding cognitive-behavioral treatments may improve retention and outcome. We hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of TC processes and techniques. We predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach.

To begin to improve retention, TC research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. We have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 TC residents. In addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the TC.

Eligibility criteria: Admission for residential TC treatment at APT Residential Services Division

Inclusion Criteria:

Adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak English

Exclusion Criteria:

Acute suicidality, homicidality, psychosis, mania

Primary outcomes:
measure: Retention
measure: Psychosocial functioning
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: APT Foundation, Inc.
name: Samuel Ball, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06117098: Mobile App for Risk Reduction of Type 2 Diabetes
Official title: Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetic State
Keywords: Prevention
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT feasibility study, non-inferiority and superiority trial
Primary purpose: PREVENTION

Brief summary: The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.

Detailed description: A small scale RCT will be carried out a the collaborating Healthy Life Centres (HLC). Trained health personnel will deliver the lifestyle programs at these centres, and the content of their programs should be in line with the national guidelines for physical activity and nutrition. The study sample 60 participants with high risk of developing diabetes type 2.

The participants will be randomized into three study arms, 20 participants in each. One group, the intervention group, will receive the mobile app, the second group will receive group-based lifestyle intervention at the HLCs and the third group will receive group based lifestyle intervention at the HLCs and a mobile application. The middle arm will serve as the control arm for both the non-inferiority trial ( mobile application group and HLC lifestyle intervention only) and for the superiority trial (HLC lifestyle intervention plus mobile app and HLC intervention only).

Eligibility criteria: Inclusion Criteria:

* smart phone
* prediabetes

Exclusion Criteria:

* not interested in lifestyle change

Primary outcomes:
measure: Recruitment rate
timeFrame: Six months
measure: Resources
timeFrame: Nine months
measure: Management
timeFrame: Nine months
measure: Satisfaction with the app
timeFrame: Three months
measure: Change and ceiling and floor effect in outcomes
timeFrame: Three months
Secondary outcomes:
measure: Antropometric measures
timeFrame: Three months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet
Study officials:
affiliation: OsloMet
name: Birgitta Blakstad Nilsson, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593198: Guided Bone Regeneration Versus Bone Block Grafting
Official title: Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy; Bone
Keywords: Bone Regeneration
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.


Eligibility criteria: Inclusion Criteria:

* Patients in need of an implant-supported rehabilitation
* Patients requiring bone regeneration
* Healthy patients
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
* Sufficient mesiodistal and interocclusal space
* At least 6 months of follow-up

Exclusion Criteria:

* An American Society of Anesthesiologists physical status classification ≥ III
* General contraindications for surgical treatment or implant placement
* Untreated periodontitis
* Smoking
* Excessive alcohol consumption
* Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
* No residual keratinized tissue at the experimental area
* Unwillingness to return for follow-up examinations

Primary outcomes:
measure: Bone volume
timeFrame: 6 Months follow up
Secondary outcomes:
measure: Periodontal parameters
timeFrame: 6 Months follow up
measure: Wound healing
timeFrame: 2 weeks follow up
measure: Histological analysis
timeFrame: 6 Months follow up
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
affiliation: Fondazione Policlinico Gemelli
name: Antonio D'Addona, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03629145: Music Therapy With Intubated and Sedated Pediatric Patients
Official title: The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 33
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.

Detailed description: Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
* mechanically ventilated
* sedated
* Patients with underlying diagnosis accepted unless listed below
* Patients must have a primary caregiver present

Exclusion Criteria:

* Patients who are oscillating
* have a previous diagnosis of severe or profoundly deaf
* have a suspicion of child abuse
* in custody of the state.

Primary outcomes:
measure: Heart Rate
timeFrame: up to sixty minutes post intervention.
measure: Respiratory Rate
timeFrame: up to sixty minutes post intervention.
measure: Blood Pressure
timeFrame: up to sixty minutes post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
References:
citation: Austin D. The psychophysiological effects of music therapy in intensive care units. Paediatr Nurs. 2010 Apr;22(3):14-20. doi: 10.7748/paed2010.04.22.3.14.c7637.
citation: Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111/j.1365-2702.2009.02845.x.
citation: Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: A review. Heart Lung. 2015 Sep-Oct;44(5):416-25. doi: 10.1016/j.hrtlng.2015.06.010. Epub 2015 Jul 27.
Clinical trial NCT02274298: Improving Care for Patients With Chronic Kidney Disease Using EMRALD
Official title: Improving Care for Patients With Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Ontario Renal Network
First posted: 2014-10-24
Enrollment: 221
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pragmatic cluster randomized controlled trial will test the impact of feedback and a toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary care setting. This trial will use family physicians in Ontario participating in the Electronic.

Detailed description: This trial will use family physicians in Ontario participating in the Electronic Medical Record Administrative data Linked Database (EMRALD) and receiving the System for Audit and Feedback to Improve caRE (SAFIRE) along with other decision support tools. Performance on CKD quality indicators for family physicians receiving the CKD feedback and tools will be compared to physicians not receiving the CKD feedback or tools.

Eligibility criteria: Inclusion Criteria:

* Family physicians participating in EMRALD, on the EMR for \>=2 years, roster size \>=100 patients
* Patient criteria, rostered and actively seeing an EMRALD physician, on the EMR for .=1 year

Exclusion Criteria:

* Updated data available at the time of study commencement

Primary outcomes:
measure: Proportion of patients age 50-80 with Stage 3+ CKD and a statin prescription
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of patients at high risk screened for CKD with an eGFR and/or ACR
timeFrame: 24 months
measure: Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR
timeFrame: 24 months
measure: Proportion of patients with diabetes and albuminuria and on an ACE or ARB
timeFrame: 24 months
measure: Proportion of patients meeting eGFR criteria for CKD and documentation of CKD in the cumulative patient profile (CPP)
timeFrame: 24 months
measure: Proportion of patients with an ACR in the past 18 months and meeting bp targets
timeFrame: 24 months
measure: Proportion of patients age less than 80 years and an eGFR<30 being seen by or with a referral to a Nephrologist
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: ICES/Sunnybrook
name: Karen Tu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nash DM, Ivers NM, Young J, Jaakkimainen RL, Garg AX, Tu K. Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol. Can J Kidney Health Dis. 2017 Apr 5;4:2054358117699833. doi: 10.1177/2054358117699833. eCollection 2017.
Clinical trial NCT05810545: Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity
Official title: Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Weight
Small for Gestational Age at Delivery
Large for Gestational Age at Delivery (Macrosomia)
Diabetes, Gestational
Hypertension in Pregnancy
Preeclampsia
Congenital Malformation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: The Swedish Research Council
name: Statistics Sweden
name: National Board of Health and Welfare, Sweden
name: Swedish University of Agricultural Sciences
name: Swedish Food Agency
First posted: 2023-04-12
Enrollment: 256659
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018, where PFAS exposure data is available.

Brief summary: The aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.


Eligibility criteria: Inclusion Criteria:

* Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018

Exclusion Criteria:

* Lack of data of PFAS levels in municipal drinking water (entire localities excluded)
* Mothers not living in the study area consistently between first trimester and four years prior to birth

Primary outcomes:
measure: Birth outcome - birthweight
timeFrame: at birth
measure: Birth outcome - Small for gestational age (SGA)
timeFrame: at birth
measure: Birth outcome - Large for gestational age (LGA)
timeFrame: at birth
measure: Birth outcome - major congenital malformations
timeFrame: at birth
measure: Maternal health - Gestational hypertension/preeclampsia
timeFrame: during gestation
measure: Maternal health - Gestational diabetes mellus
timeFrame: during gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01801345: The Effect of Fatigue on the Clinical Performance
Official title: The Effect of Fatigue on the Clinical Performance of Experienced Physicians: A Simulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Human Performance
Clinical Performance
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary aim of this randomized controlled trial is to examine the effect of fatigue on clinical performance in a simulated obstetric emergency. This scenario was chosen because it is a common clinical situation faced by anesthesia providers on call and therefore likely to occur when a provider is fatigued. Secondary outcomes will include the evaluation of other factors that worsen fatigue related decrement in performance including age, years of training/practice and clinical load prior to study participation.


Eligibility criteria: Inclusion Criteria:

* All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.

Exclusion Criteria:

* Resident physician or trainee, physician not taking overnight in house call.

Primary outcomes:
measure: Clinical performance Score
timeFrame: 24 months
Secondary outcomes:
measure: Stanford Sleepiness Scale
timeFrame: 24months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT06222645: PPG vs. ICG in Gastrointestinal Resections
Official title: Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anastomosis
Perfusion
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
Collaborators: name: Shandong Linglong Yingcheng Hospital
First posted: 2024-01-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, gastrointestinal anastomoses are examined with imaging Photoplethysmography and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared.

Detailed description: All gastrointestinal anastomoses were examined in all patients with written informed consent.

As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Imaging photoplethysmography (iPPG) as new method.IPPG is an optical technique in which a conventional video camera is used to detect tiny modulations associated with blood pulsation in vessels.This technique is contactless, extremely simple, and does not affect hemodynamic processes in living organs. It is an emerging technique that allows to sense cardiovascular signals in the outer skin layers.Various research groups recently applied iPPG to monitor the vascular changes (dilatation or vasoconstriction) caused by functional tests.These experiments suggest that the normalized amplitude of the photoplethysmography (PPG) waveform can be considered as a perfusion index. More recently, our group has demonstrated the feasibility of using iPPG to assess changes in cortical blood flow in open brain neurosurgery and tissue perfusion during abdominal surgery.

As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.

Eligibility criteria: Inclusion Criteria:

* all gastrointestinal anastomoses

Exclusion Criteria:

* inability to consent
* allergy against indocyaningreen dye

Primary outcomes:
measure: Processing of iPPG data
timeFrame: After the intraoperative video is taken, within 5 minutes
measure: Anastomotic perfusion in digestive system
timeFrame: After the intraoperative video is taken, within 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yantai
country: China
facility: Shandong Linglong Yingcheng Hospital
state: Shandong
city: Saint Petersburg
country: Russian Federation
facility: Department of Faculty Surgery, Saint Petersburg State University
state: Leningrad Oblast
Study officials:
References:
Clinical trial NCT01781845: Hydronephrosis ARFI Study
Official title: Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydronephrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 41
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: Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or younger
2. You are scheduled for diuretic scintigraphy (DRS)testing -

Exclusion Criteria:

None

-

Primary outcomes:
measure: ARFI-SVI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Jonathan Dillman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: