louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06000241: Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia
Official title: Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation Under Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants have a cluster of elective EGD and colonoscopy under anesthesia.

Brief summary: 220 patients are allocated randomly to the morning group (am group) or the afternoon group (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.


Eligibility criteria: Inclusion Criteria:

Patients are able to follow the instructions of bowel preparation and have good ability of walking at least an hour.

Exclusion Criteria:

Clinical diagnosis of obstruction of bowel and sever renal and heart disease.

Primary outcomes:
measure: ottawa score
timeFrame: a day
measure: gastric residual volume
timeFrame: 30 minutes
measure: colonic residual volume
timeFrame: 30 minutes
Secondary outcomes:
measure: reflux
timeFrame: 60mins
measure: adenoma detection rate
timeFrame: a day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT00395941: Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2006-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic plaque type psoriasis having body surface area involvement of \> 20%
* Patients of either sex
* Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
* Age range 18-65 years

Exclusion Criteria:

* Females of child bearing potential
* H/O hypersensitivity to acitretin
* Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase \>1.5 times the upper limit of normal)
* Impaired renal function (serum creatinine \>1.5mg% in males and \>1.4 mg% in females)
* Hyperlipidemia
* BMI \>30 kg /m2
* H/O excessive alcohol use
* Diabetes mellitus
* Congestive heart failure
* Ischemic heart disease

Primary outcomes:
measure: Change in PASI score from baseline in the two groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Sunil Dogra, MD
role: STUDY_CHAIR
References:
citation: Mittal R, Malhotra S, Pandhi P, Kaur I, Dogra S. Efficacy and safety of combination Acitretin and Pioglitazone therapy in patients with moderate to severe chronic plaque-type psoriasis: a randomized, double-blind, placebo-controlled clinical trial. Arch Dermatol. 2009 Apr;145(4):387-93. doi: 10.1001/archdermatol.2009.5.
Clinical trial NCT03457441: Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method
Official title: Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Near Vision
Lead sponsor: Tilak Healthcare
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Able to correctly distinguish the body laterality (left and right)
* Able to recognize alphabet letters and read French
* Affiliated to or beneficiary of the French health care system
* Signed/written informed consent
* Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.

Exclusion Criteria:

* Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
* Pregnant and breastfeeding women.
* Subject not considered by the investigator or designee to correctly use OdySight modules after the training session

Primary outcomes:
measure: Near visual acuity assessment with OdySight versus with near visual acuity chart
timeFrame: 1 day ( During evaluation visit)
Secondary outcomes:
measure: Near visual acuity assessment with OdySight versus with ETDRS chart
timeFrame: 1 day ( During evaluation visit)
Other outcomes:
measure: Contrast sensitivity assessment with OdySight versus with Pelli-Robson
timeFrame: 1 day ( During evaluation visit)
measure: Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid
timeFrame: 1 day ( During evaluation visit)
measure: Global functional disorders assessment with Odysight versus with OCT
timeFrame: 1 day ( During evaluation visit)
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
state: Ile-de-France
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Saddek Mohan-Saïd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Said S. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25.
Clinical trial NCT00624741: Compassionate Use Study of Pergolide in Patients With Parkinson's Disease
Official title: Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Antiparkinsonian
Compassionate use
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past
* Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease
* No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior

Exclusion Criteria:

* History or current diagnosis of cardiac valvulopathy
* Inability to undergo echocardiograms every 6 months while receiving pergolide
* Hypersensitivity to pergolide or other ergot derivatives

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04095741: Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission
Official title: Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Autism Spectrum Disorder
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2019-09-19
Enrollment: 34
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were previously treated in UZ Brussel for anorexia nervosa. Intake happened at least one year ago.

Brief summary: With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.

Detailed description: 34 patients who are still minors and were previously treated in the Child and Adolescent Psychiatry Department (PAika) of the University Hospital in Brussels, will be contacted to ask if they would volunteer in this investigation. If the minors and their parents give their permission, they will be asked to fill in multiple questionnaires, measuring the current symptoms of anorexia nervosa, characteristics of autism spectrum disorder and global functioning of the minors. The questionnaires will be send and returned by post.

Eligibility criteria: Inclusion Criteria:

* Patients speaking Dutch
* Previously treated in UZ Brussel for anorexia nervosa
* Informed consent signed by children and parent(s)

Exclusion Criteria:

* Patients and/or parents don't speak Dutch
* Adults
* No informed consent obtained

Primary outcomes:
measure: Symptoms of autism spectrum disorder
timeFrame: The measurment will be done once during the period of October 2019 to March 2020.
Secondary outcomes:
measure: Global functioning
timeFrame: The measurment will be done once during the period of October 2019 to March 2020
measure: Symptoms of anorexia nervosa
timeFrame: The measurment will be done once during the period of October 2019 to March 2020
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT05558241: Micro-UltraSound In Cancer - Active Surveillance
Official title: Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Active surveillance
micro-ultrasound
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 210
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective paired diagnostic trial
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.


Eligibility criteria: Inclusion Criteria:

* Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy

Exclusion Criteria:

* Men who cannot undergo a prostate MRI
* Men who cannot undergo a prostate biopsy

Primary outcomes:
measure: Cancer upgrading during Active surveillance by micro-ultrasound and MRI
timeFrame: Immediately after biopsy.
Secondary outcomes:
measure: Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.
timeFrame: Immediately after biopsy.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles, Department of Urology
state: California
city: Edmonton
country: Canada
facility: Kipnes Urology Centre - Kaye Edmonton Clinic
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: Alberta
city: Montreal
country: Canada
facility: CIUSSS du Nord-de-L'Ile-De-Montreal
state: Quebec
Study officials:
affiliation: University of Alberta
name: Adam Kinnaird, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108741: Augmented Reality Treadmill Training in Patients With Parkinson's Disease
Official title: Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Fall
Keywords: Parkinson Disease
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gait disorder is a disabling symptom in Parkinson's disease (PD) affecting all patients during the course. Three methods of treadmill training (TT) will be compared to assess additional augmented reality (AR), or additional dual task (DT). AR TT, DT TT, and TT alone applied over 3 weeks at each day will be compared for their impact on falls, walking, freezing and attention for 3 months in a double blinded randomized controlled trial during regular neurorehabilitation.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Parkinson´s disease without dementia and hallucination
* at least one fall within the past 3 months or postural instability
* Gait disorder
* Hoehn and Yahr stages II-IV
* able to perform the treadmill therapy during a study

Exclusion Criteria:

* Contraindications to treadmill therapy (e.g. hip fracture)
* Dementia as defined by an Montreal cognitive assessment (MOCA) \< 20

Primary outcomes:
measure: Frequency of falls
timeFrame: 3 months before study to 3 months following the study
Secondary outcomes:
measure: Secondary outcomes:
timeFrame: before and after the training period of 3 weeks
measure: Sensor based gait analyses
timeFrame: before and after the training period of 3 weeks and after 3 months
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Department of Neurology
state: Saint Gallen
Study officials:
affiliation: Department of Neurology, Kliniken Valens
name: Veit Mylius, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01165619: Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders
Official title: Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Hypothalamic Amenorrhea
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The reproductive disorder populations will be recruited from the reproductive endocrine clinic at the Mass General Hospital. The control populations will be recruited from Boston and surrounding communities

Brief summary: In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 for men
* Between the ages of 18 and 40 for women
* For reproductive disorder population: Current or previous diagnosis of Idiopathic Hypogonadotropic Hypogonadism or Hypothalamic Amenorrhea

Exclusion Criteria:

* chronic disease (hypertension, high cholesterol, diabetes, asthma, etc)
* polycystic ovarian syndrome for women
* prescription medication use (other than allergy meds) for control populations
* irregular menstrual cycles for healthy female control population (cycle length longer than 35 days or shorter than 25 days. cycle length varies by more than 5 days. less than 9 periods per year)

Primary outcomes:
measure: Serum/plasma markers
timeFrame: baseline
Secondary outcomes:
measure: Genetics
timeFrame: baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02160119: Emotional and Change-related Attention in Autism
Official title: Emotional and Change-related Attention in Autism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders
Emotion
Attention
Event-related potential
Functional neuroimaging
Diffusion Tensor Imaging
Development
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children/ adults with ASD and healthy children/ adults

Brief summary: Several studies seem to indicate that emotional attention and change-related attention are impaired in ASD. The goal of this study is to identify the relationships between those two types of automatic attention in visual and auditory modalities in subjects with ASD compared to healthy controls and also, over the course of development (children, adults). In order to achieve this goal, the investigators will use complementary techniques (EEG and MRI-based techniques (fMRI, DTI)).

Detailed description: Autism Spectrum Disorders (ASD) are characterized by major handicap in social interaction and in daily life adaptation. The orienting response towards potentially relevant events involves automatic attentional mechanisms that would be elicited mainly by two classes of biologically important stimulations: novel stimuli and emotional stimuli. The neural basis of emotional and change-related attention in ASD will be explored by investigating brain reactivity in both visual and auditory modalities, during tasks mixing emotional and non emotional stimuli.

Eligibility criteria: Inclusion Criteria:

* No past history of central nervous system disorders
* Written consent
* Affiliated to the National Health Insurance
* Do not participate to another biomedical research
* For ASD group: Children with autism spectrum disorder (DSM-V criteria) and adults with high-functioning autism
* For healthy subjects: No past history of difficulties in early childhood for acquisition of walk, language or reading and no psychiatric disorders

Exclusion Criteria:

* Abnormal corrected vision
* Abnormal audition
* Not stabilized psychoactive treatment or treatment that can modify electrogenesis
* Infectious or metabolic diseases
* Epilepsies
* Impossibility to participate to the whole study
* For subjects participating to the MRI recordings: MRI counter-indications (pace-makers ...), claustrophobia or a positive pregnancy test

Primary outcomes:
measure: Neural responses to neutral and emotional stimuli
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Frédérique BONNET-BRILHAULT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05424419: Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis
Official title: Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: scoliosis
nighttime bracing
full-time bracing
Chêneau brace
Charleston brace
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 115
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AIS were managed as recommended by SOSORT Consensus statement. Inclusion criteria were according to the Scoliosis Research Society criteria. Initial diagnostics included a clinical examination, standardized X-ray of the entire spine in standing position. Patients for whom cost coverage of double-brace therapy was denied by the health insurance company received a single full-day and nighttime Chêneau type brace treatment. All other patients received a Chêneau brace for daytime and a Charleston type nighttime bending brace. Patients who were prescribed the brace were instructed to wear it for 23 hours/day. Patients were seen at 6-month intervals, at which times we collected radiographic, clinical, orthotic, and self-reported data.

Brief summary: Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.

Detailed description: One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.

Eligibility criteria: Inclusion Criteria:

* AIS
* age between 10 and 15 years (y)
* Risser's sign of 0-2
* Cobb curvature angle of 25-40°
* no previous treatment
* compliance (at least 23 h wearing time)

Exclusion Criteria:

* non-idiopathic scoliosis
* Cobb curvature angle \>40°
* \<10 years and \>15 years for initial treatment

Primary outcomes:
measure: primary correction
timeFrame: At study inclusion with initiation of brace therapy
Secondary outcomes:
measure: Cobb angle reduction
timeFrame: 2 years after deposition of the brace
Other outcomes:
Locations:
Study officials:
References: