louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02581072: A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
Official title: A Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Spaulding Clinical Research LLC
First posted: 2015-10-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Detailed description: A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Eligibility criteria: Inclusion Criteria:

* Moderate to severe acne
* 20 inflammatory and 25 non-inflammatory acne lesions

Exclusion Criteria:

* Pregnant, trying to become pregnant, or nursing
* Known allergy to any component of the topical SB204 formulation

Primary outcomes:
measure: Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo.
timeFrame: 15 days
Secondary outcomes:
measure: Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms.
timeFrame: 15 days
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research, LLC
state: Wisconsin
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03380572: Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Official title: Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Colic
Cholecystitis
Keywords: Robotic Surgery
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.

Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.


Eligibility criteria: Inclusion Criteria:

ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs

Exclusion Criteria:

Patients unable tor unwilling to consent BMI \>40

Primary outcomes:
measure: Operative Time
timeFrame: 1 day
Secondary outcomes:
measure: Morbidity Data
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Sanjay Purkayastha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039272: Epstein-Barr Detection in Oral Cancer
Official title: Epstein-Barr Detection in Squamous Cell Carcinoma and Healthy Oral Mucosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Keywords: oral cancer
EBV
PCR
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: oral care clinic, community sample

Brief summary: The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for the possible presence of Epstein-Barr virus (EBV).

Detailed description: Epstein-Barr virus has been implicated in a range of malignant neoplasms, including in some studies, in the aetiology of oral squamous cell carcinoma but the influence of EBV in oral cancer remains unclear. This study will examine the prevalence of EBV infection in oral cancer by means of nested polymerase chain reaction.

Eligibility criteria: Inclusion Criteria:

* patients of Oral Cancer Centre - UNESP/Araçatuba - SP
* with oral squamous cell carcinoma

Exclusion Criteria:

* without oral squamous cell carcinoma

Primary outcomes:
measure: presence of EBV
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Araçatuba
country: Brazil
facility: Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
state: São Paulo
Study officials:
affiliation: Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
name: Glauco Issamu I Miyahara, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
name: Lívia T Arêde, student
role: STUDY_CHAIR
References:
Clinical trial NCT01789372: Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation
Official title: Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
yoga
quality of life
blood pressure
heart rate
heart rate variability
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic. All participants should have been on usual treatment (medication, cardio version or ablation) for at least three months.

Brief summary: The purpose of this study is to determinate if mediyoga has effects in quality of life, heart rate variability, blood pressure , heart rate in patients with paroxysmal atrial fibrillation (PAF).

Detailed description: This is randomized prospective pilot study. Eighty patients from Danderyd hospital, Stockholm, Sweden were randomized to either mediyoga group or control group. The mediyoga group were completing yoga for one hour, once a week for 12 weeks together with usual treatment. The controlgroup had only usual treatment.The usual treatment consists of pharmaceutical, cardio version and ablation. Quality of life ( SF-36, EQ-5d), blood pressure, heart rate and 24-hours ekokardiografi were measured at baseline and after twelve weeks.A follow up after six months was accomplished with SF-36 and EQ-5d, bloodpressure and heart rate.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PAF

Exclusion Criteria:

* The exclusions criteria were multiple concurrent medical conditions and/or cognitive dysfunction (in the diagnosis of e.g. mental illness), considered not to be able to carry out yoga owing to ability to move and those who have difficulties to understand the Swedish language.

Primary outcomes:
measure: Quality of life
timeFrame: Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.
measure: Quality of life
timeFrame: Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month
Secondary outcomes:
measure: Blood pressure
timeFrame: Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months
measure: heart rate
timeFrame: Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.
measure: Heart variability
timeFrame: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyds hospital
Study officials:
affiliation: Danderyd hospital, Karolinska Institute Sweden
name: Viveka Frykman, Phd, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04055272: A Mobile Text Messaging Intervention for Indoor Tanning Addiction
Official title: A Mobile Text Messaging Intervention for Indoor Tanning Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indoor Tanning
Keywords: indoor tanning
skin cancer
mobile health
text messaging
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized trial with two groups: 1) Indoor tanning education only; 2) Mobile text messaging intervention
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of indoor tanning delivered via mobile text messaging among young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction.

Detailed description: This is a two arm randomized controlled trial to test the effects of messages communicating the risks of indoor tanning delivered via mobile text messaging as a strategy for promoting cessation among young adult women who meet screening criteria for indoor tanning addiction. Eligible participants are young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction and have access to the internet and a personal mobile phone to complete study procedures. Participants will complete baseline measures and then be randomized to the study arms. The text messaging intervention exposure in the intervention arm will last for four weeks. The control arm will be given basic indoor tanning education information and will not receive any intervention. Follow up assessments capturing study outcomes will be administered at 1 month (i.e., immediately post-intervention) and three months post-intervention.

Eligibility criteria: Inclusion Criteria:

* Female
* Age between 18 and 30 years
* Meet self-report criteria for tanning addiction
* Has access to the internet to complete study procedures
* Has personal mobile phone to complete study procedures

Exclusion Criteria:

* Male
* Age less than 18 or greater than 30
* Does not meet self-report criteria for tanning addiction
* Does not have access to the internet to complete study procedures
* Does not have a personal mobile phone to complete study procedures

Primary outcomes:
measure: Motivation to Quit Indoor Tanning
timeFrame: 1 month follow up
measure: Indoor Tanning Cessation
timeFrame: 1 month follow up
Secondary outcomes:
measure: Attempts to Quit Indoor Tanning
timeFrame: 1 month follow up and 3 month follow up
Other outcomes:
measure: Risk Appraisals
timeFrame: 1 month follow up and 3 month follow up
measure: Efficacy Beliefs
timeFrame: 1 month follow up and 3 month follow up
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Darren Mays, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01437072: Changing Diabetes® World Tour
Official title: Changing Diabetes® World Tour a Study on the Association of Risk Factors and the Presence of Undiagnosed Diabetes in the Middle East, Northern Africa and Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 8304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Changing Diabetes® World Tour is designed as a mobile screening clinic staying for a minimum of 14 days in each location such as malls, public squares, etc. Subjects included in the study are either actively seeking to be screened, or are invited by subjects in their network already included in the study.

Brief summary: This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study is to contribute to the design of a simple screening strategy for countries in scope, by exploring the association between risk factors and undiagnosed diabetes in a screening study.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained

Exclusion Criteria:

* Subjects with known diabetes (exception: women with a history of gestational diabetes should not be excluded)
* Pregnant women or women who have given birth within less than a month
* Subjects suffering from severe illness
* Subjects with the inability to read and understand the information given (either due to illiteracy or vision problems) and therefore unable to give an informed consent
* Subjects with mental impairment
* Subjects treated with systemic cortico-steroids

Primary outcomes:
measure: HbA1c (Glycosylated Haemoglobin) level
timeFrame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Secondary outcomes:
measure: Number of subjects with diabetes (type 1 and 2)
timeFrame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
measure: The presence of retinopathy
timeFrame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Other outcomes:
Locations:
city: Paco de Arcos
country: Portugal
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Handlos LN, Witte DR, Almdal TP, Nielsen LB, Badawi SE, Sheikh AR, Belhadj M, Nadir D, Zinai S, Vistisen D. Risk scores for diabetes and impaired glycaemia in the Middle East and North Africa. Diabet Med. 2013 Apr;30(4):443-51. doi: 10.1111/dme.12118.
Clinical trial NCT01284972: HINTEGRA Total Ankle Prosthesis Follow-up
Official title: Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Ankle Prosthesis
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years

Brief summary: The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis.

The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.


Eligibility criteria: Inclusion Criteria:

* Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
* Age ≥ 18 years
* Have willingness to give his/her data transfer authorisation

Exclusion Criteria:

* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Primary outcomes:
measure: rate of device related complications at the follow up after 2 years of implantation
timeFrame: more than 2 years after the implantation
Secondary outcomes:
measure: AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).
timeFrame: more than 2 years after the implantation
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Amiens
country: France
facility: CHU d'Amiens - Hopital Nord
city: Wiesbaden
country: Germany
facility: AukammKlinik
city: Seoul
country: Korea, Republic of
facility: Severance Hospital - Yonsei University
city: Barcelona
country: Spain
facility: Hopital San Rafael
Study officials:
References:
Clinical trial NCT05281172: Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings
Official title: Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse or Dependence
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2022-03-16
Enrollment: 800
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study corresponds to a pretest-posttest randomized experimental design with two arms. Arm 1 includes Guided Self-Change program, and Arm 2 a psychoeducational program to promote healthy habits. This study aims to analyze the efficacy of a selective and indicated prevention program based on the Guided Self-Change model (GSC) in adolescent alcohol users between 16-18 years. Researchers hypothesize that implementation of GSC therapy will lead to a greater reduction of alcohol drinkers compare with the control condition, and will prevent alcohol abuse after 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* 16-18 years old.
* Having inform consent from parents
* Report using alcohol at least once a month during the previous last three months

Exclusion Criteria:

* Participants will be excluded if they refer being diagnosed with a severe mental disorder.
* Have a severe medical illness that will limit participation
* Being under treatment for a psychological of psychiatric problem.
* Meet DSM criteria for Drug dependence to illegal drugs.

Primary outcomes:
measure: Alcohol use change
timeFrame: Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention
measure: Alcohol abuse
timeFrame: Change from baseline to week 5, and at 6 and 12 months post intervention.
measure: Alcohol dependence
timeFrame: Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary outcomes:
measure: Drug use
timeFrame: Change from baseline to week 5, and at 6 and 12 months post intervention.
measure: Impulsiveness
timeFrame: Change from baseline to week 5, and at 6 and 12 months post intervention.
measure: Sleep quality
timeFrame: Change from baseline to week 5, and at 6 and 12 months post intervention.
Other outcomes:
Locations:
city: Elche
country: Spain
facility: José Luis Carballo
state: Alicante
Study officials:
affiliation: Miguel Hernández University of Elche
name: José Luis Carballo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662372: Functional Neurological Disorders in Patients Admitted in Stroke Units
Official title: Functional Neurological Disorders in Patients Admitted in Stroke Units: Clinical Profile et and 6 Months Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Neurological Disorders
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in stroke unit for a neurological deficit, without evidence of neurovascular or othe neurological disease

Brief summary: Functional neurological disorders are an important subgroup of patients with stroke mimics admitted to stroke unit.Their clinical profile and outcome are poorly known. The goal of this study is to describe the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Patients admitted in stroke unit for a neurological deficit, without evidence of neurovascular or othe neurological disease.
* NIHSS ≥ 1 at time of admission
* Informed and consent patient to study
* Health insured

Exclusion Criteria:

* Patient receiving legal protection
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Patient characteristics
timeFrame: 3 months
Secondary outcomes:
measure: symptoms of patients
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Fondation Adolphe de Rothschild
Study officials:
References: