louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00570505: Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2.

Detailed description: LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.

Eligibility criteria: Inclusion Criteria:

* Have a BMI ≥ 30 kg/m2 and \< 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and \< 40 kg/m2 without severe comorbid conditions
* Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion Criteria:

* Subject history of congenital or acquired anomalies of the gastrointestinal tract
* Severe cardiopulmonary or other serious or uncontrolled organic disease
* Severe coagulopathy; hepatic insufficiency or cirrhosis
* History of bariatric; gastric; or esophageal surgery
* History of intestinal obstruction or adhesive peritonitis
* History of esophageal dysmotility disorders
* Type I diabetes

Primary outcomes:
measure: Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation
timeFrame: One year
Secondary outcomes:
measure: Percent Weight Loss
timeFrame: Baseline through 12 months
measure: Change in Comorbid Conditions Related to Obesity
timeFrame: 12 months
measure: Change in Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
state: Washington
Study officials:
References:
citation: Michaelson R, Murphy DK, Gross TM, Whitcup SM; LAP-BAND Lower BMI Study Group. LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study. Obesity (Silver Spring). 2013 Jun;21(6):1148-58. doi: 10.1002/oby.20477.
Clinical trial NCT05200598: Cardiovascular Risk Predictors in Patients With Psoriasis
Official title: Cardiovascular Risk Predictors in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Cardiovascular Diseases
Keywords: psoriasis
cardiovascular risk
risk factors
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Considering the different severity of psoriasis, it is possible to divide patients with psoriasis into several subgroups: patients with mild psoriasis; patients with moderate psoriasis; patients with severe psoriasis who are not receiving systemic therapy; patients with severe psoriasis receiving systemic therapy with genetic-engineering biological drugs; patients with psoriatic arthritis receiving genetic-engineering biological drugs.

Brief summary: The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. The traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. As it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Written informed consent of the patient to participate in the study

Exclusion Criteria:

* Age under 18
* Pregnancy, lactation
* Very high cardiovascular risk
* Life-threatening, independently influencing prognosis and disabling diseases,
* Mental disorders that do not allow to give informed consent or answer questions adequately
* Refuse of the patient to participate in the study

Primary outcomes:
measure: SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person)
timeFrame: 1 year
Secondary outcomes:
measure: Overall mortality
timeFrame: 1 year
measure: Cardiovascular mortality
timeFrame: 1 year
measure: Progression of psoriasis (PASI)
timeFrame: 1 year
measure: Quality of life (DLQI score)
timeFrame: 1 year
measure: Hospitalization due to cardiovascular reasons
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Clinical Hospital #2
Study officials:
affiliation: Sechenov University
name: Olga Mironova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05944198: Clinical Study of 18F-FAPI-RGD PET/CT in Rheumatoid Arthritis
Official title: Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.

Brief summary: The goal of this observational study is to learn about 18F-FAPI-RGD PET/CT imaging in assessing rheumatoid arthritis disease activity. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Detailed description: Patients with rheumatoid arthritis who met the 2010 American College of Rheumatology/European League against Rheumatism Rheumatoid arthritis classification criteria will be included. All patients will be assessed for disease activity and the clinical disease activity Index (cDAI) was calculated. Blood sedimentation rate and CRP assay results will be collected. All patients will undergo 18F-FAPI-RGD PET/CT examination. The correlation of cDAI, ESR and CRP levels with PET joint count and PET joint index as measured by 18F-FAPI-RGD PET/CT will be statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.

Exclusion Criteria:

* A. Patients with malignant tumors and other rheumatic immune diseases; B. clinical and conventional radiographic inspection of materials; C. researchers think not suitable for other information to participate in this study.

Primary outcomes:
measure: Correlation between clinical indicators and PET/CT results
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT00891098: Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)
Official title: Comparing Imaginal Exposure (IE) and Imagery Rescripting and Reprocessing Therapy (IRRT) in the Treatment of Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Modum Bad
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-05-01
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by which emotions that are predominant among current symptoms, e.g. fear, anger, guilt, shame. Different treatment procedures for processing traumatic memories may resolve different emotions. This study compares two different treatment procedures of working with trauma memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to test this.

Detailed description: The main objectives of this study are:

1. To assess the relative efficacy of the two procedures in inpatient treatment for PTSD
2. To assess whether the predominant emotions in the traumatic memories moderate the outcome of the different procedures
3. To assess whether theory-derived constructs mediate outcome and whether the mediating relationships are different in the two treatments
4. To provide a theoretical account of the two models
5. To psychometrically evaluate 3 new measures

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of PTSD identified as primary diagnosis
* Accepts withdrawal of all psychotropic medication

Exclusion Criteria:

* Extensive dissociative symptoms or current psychosis,
* Current suicidal risk,
* Extensive current substance or alcohol abuse, or
* Ongoing trauma

Primary outcomes:
measure: PTSD symptoms
timeFrame: pretreatment, weekly during treatment, posttreatment, followup
Secondary outcomes:
measure: General psychiatric symptoms
timeFrame: pretreatment, weekly during treatment, postttreatment, followup
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
affiliation: Modum Bad and University of Oslo
name: Asle Hoffart, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00963898: Accurate Controlled Dental Sedation
Official title: The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Retardation
Keywords: Intravenous sedation
Target controlled infusion
Bispectral index
Dental treatment
Mental Retardation
Deep sedation
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.

Detailed description: The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Eligibility criteria: Inclusion Criteria:

1. Participants aged 16 or over,
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatments of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

1. Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons,
2. Patients needed premedication
3. Patients had uncontrolled or sever medical condition

Primary outcomes:
measure: The dose of anesthesia agent
timeFrame: 1 day
measure: The recovery times of eyelash reflex and eye opening
timeFrame: 1 day
measure: The time to going home
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Department of Dental Anesthesiology, Okayama University Hospital
Study officials:
affiliation: Okayama University
name: Hitoshi Higuchi, D.D.S., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00819598: Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures
Official title: Pilot Study to Determine the Optimal Oscillometric-Based Technique for Measurement of Ankle Blood Pressures for the Ankle-brachial Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Summit Doppler Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2009-01-09
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to Cleveland Clinic's non-invasive vascular lab

Brief summary: Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure based on measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement and determination of the ankle-brachial index has been applied with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity.

The purpose of this study is to determine the optimal oscillometric-based technique for estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the ankle-brachial index in patients with and without PAD.

Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a subset of subjects will be obtained in both seated and supine positions. The ankle-brachial index and toe-brachial index will be calculated.


Eligibility criteria: Inclusion Criteria:

* Patient at least 50 years of age
* Ambulatory outpatient
* Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease.

Exclusion Criteria:

* Unable to give informed consent
* Unable to lie supine for at least 15 minutes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Heather L Gornik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03913598: Internet and Social Media Use in Dermatology Patients
Official title: Internet and Social Media Use in Dermatology Patients - a Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatologic Diseases
Keywords: social media use
online medical services
internet use
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients treated at the Department of Dermatology of University Hospital Basel

Brief summary: This study is to assess Internet and social media use in dermatology patients

Detailed description: The Internet and social media bear potential in terms of heath care consumer education, prevention of diseases and dissemination of evidence-based information. The use of the internet and social media platforms both by dermatologists and patients is rapidly evolving. In order to improve the presence and visibility of dermatology-related evidence-based informations on the Internet and in social media, the use and behavior of dermatology patients in this context is studied in more detail.

Eligibility criteria: Inclusion Criteria:

* Patients treated at the Department of Dermatology of University Hospital Basel

Exclusion Criteria:

* Insufficient knowledge of German language

Primary outcomes:
measure: Use of the Internet as a source of medical information
timeFrame: single time point assessment at baseline
measure: Use of Social media as a source of medical information
timeFrame: single time point assessment at baseline
measure: Duration of Internet/ Social media use by dermatology patients
timeFrame: single time point assessment at baseline
measure: Quality assessment (by patients) of medical information provided
timeFrame: single time point assessment at baseline
measure: Impact of internet/social media on the patient-physician relationship
timeFrame: single time point assessment at baseline
measure: Previous use of online medical services and online shopping of drugs/medications
timeFrame: single time point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Müller, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05719298: Infant Respiratory Interface and Accessories Evaluation Study
Official title: Infant Respiratory Interface and Accessories Evaluation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 150
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.


Eligibility criteria: Inclusion Criteria:

* Spontaneously breathing infants who require non-invasive respiratory support
* Parent(s)/guardian(s) at least 18 years of age

Exclusion Criteria:

* Parent(s)/guardian(s) unable to give written informed consent
* Neonate or infant not requiring non-invasive support
* Suspected or confirmed abnormalities or trauma to the skull or airway

Primary outcomes:
measure: Feedback score
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Mater Mothers' Hospital NICU
state: Queensland
Study officials:
References:
Clinical trial NCT05539898: Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification
Official title: Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: sudden cardiac death
heart failure
primary prevention
risk stratification
Lead sponsor: Astrakhan Federal Centre For Cardiac Surgery
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.

Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.


Eligibility criteria: Inclusion Criteria:

* LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer)
* NYHA II-IV
* favorable prediction of survival for 1 year or more

Exclusion Criteria:

* secondary SCD prevention
* indications for open heart surgery
* hypertrophic cardiomyopathy
* arrhythmogenic right ventricular dysplasia
* genetic channelopathies

Primary outcomes:
measure: Rate of VT primary occurrence
timeFrame: 24 months
Secondary outcomes:
measure: Rate of Cardiac Mortality
timeFrame: 24 months
measure: Number of Participants with CRT Response
timeFrame: 24 months
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Federal Center for Cardiovascular Surgery
state: Astrakhan Region
Study officials:
References:
citation: Ilov NN, Palnikova OV, Stompel DR, Nechepurenko capital A, CyrillicA. Clinical Predictors of Occurrence of Ventricular Tachyarrhythmias in Patients with Reduced Left Ventricle Ejection Fraction. Results of Single-Center Prospective Study. Kardiologiia. 2021 May 31;61(5):32-40. doi: 10.18087/cardio.2021.5.n1480. English, Russian.