louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01943175: Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia
Official title: Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic High Risk for Schizophrenia
Keywords: schizophrenia
stem cells
neurons
genetic hish risk for schizophrenia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2013-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Subjects at genetic high risk for schizophrenia
* Healthy control

Brief summary: This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells.


Eligibility criteria: Inclusion Criteria:

\[Subjects at genetic high risk for schizophrenia\]

* Healthy without any Axis I mental disorder
* Is a monozygotic twin of a patient with schizophrenia OR Has at least two family members of schizophrenia in the pedigree, including at least one 1st-degree family member

\[Healthy Control\]

* Healthy without any Axis I mental disorder
* No family members of schizophrenia in the pedigree to the 3rd degree

Exclusion Criteria:

* Significant neurological or medical illness
* Psychotic symptoms
* Substance abuse
* Suicidal risk
* Blindness or hearing loss
* Taking aspirin, warfarin or hormonal agents
* Pregnancy or lactation
* Susceptibility for keloid formation
* Allergy to lidocaine
* History of significant head trauma or loss of consciousness
* Mental retardation

Primary outcomes:
measure: Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls
timeFrame: three years
Secondary outcomes:
measure: CAARMS(Comprehensive assessment of at risk mental states)
timeFrame: Baseline
measure: PANSS(Positive and Negative Syndrome Scale)
timeFrame: Baseline
measure: Neurocognitive function test battery (composite)
timeFrame: Baseline
measure: ERP(event-related potential) profile
timeFrame: Baseline
measure: Structural/resting functional MRI data
timeFrame: Baseline
measure: Proton MR spectroscopy
timeFrame: Baseline
measure: PET imaging data
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jun Soo Kwon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679275: Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
Official title: Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: Heart Defects, congenital
Patient Monitoring
Infant, Newborn
Physiology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 57
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants with congenital heart defect

Brief summary: Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.


Eligibility criteria: Inclusion Criteria:

* neonates with admission on neonatal intensive care unit with congenital heart disease.

Exclusion Criteria:

* No informed consent. (for the long term neurodevelopmental FU)
* no cerebral oxygen saturation in the first 3 day's of life
* gestational age \< 37 weeks

Primary outcomes:
measure: Neurodevelopmental follow up at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: cerebrovascular changes in the transitional phase
timeFrame: first 3 days of life
measure: Association of cerebrovascular changes with short term outcome
timeFrame: time frame of 1 admission
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Neonatal Intensive Care Unit UZLeuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Liesbeth Thewissen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080975: Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Official title: Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Catheter Ablation
Atrial Flutter
Cardiac Arrhythmias
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions by delivering energy while maintaining adequate catheter contact with the endocardium. Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation catheter lacks clear indications of contact. We propose to use the Boston Scientific IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by the mini-electrodes on the ablation tip could help confirm tissue contact. Using an ultrasound catheter to define instances of clear contact and non-contact, we will determine whether the micro-electrodes produce sufficient information to confirm catheter contact. We propose that the MiFi catheter produces sufficient signal characteristics that can be used as an effective surrogate for adequate tissue contact.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of typical atrial flutter
* Subject is clinically indicated for right sided atrial flutter ablation
* Patient is willing and able to understand and sign the informed consent document
* Patient is over 18 years of age
* Patient is willing and able to comply with the study protocol

Exclusion Criteria:

* Patient has one of the following cardiac comorbidities: hypertrophic cardiomyopathy, structural heart disease, congestive heart failure
* Patient has history of the following arrhythmias: ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White syndrome
* Patient has a contraindication to right atrium ablation, including but not limited to: right atrial thrombus, active systemic infection, or a coagulopathy.

Primary outcomes:
measure: Correlation between catheter contact and micro electrode signals
timeFrame: During Procedure
Secondary outcomes:
measure: Document the electrogram signatures that help demonstrate catheter tip contact
timeFrame: During Procedure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: David B De Lurgio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02953275: Synergistic Effect of Vedolizumab and Pentoxifylline
Official title: Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Crohn Disease
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2016-11-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
* Patients who are good candidates to start standard dosing of vedolizumab
* Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
* Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
* Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
* Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening
* Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab
* Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion

Exclusion Criteria:

* Contraindications or history of allergy to PTX
* Known interaction of PTX with patient's current medications
* Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
* Pregnancy
* GFR \<30 at any time in the 6 months prior to first infusion of VDZ
* Documented cirrhosis
* Age \<18 or \>80 years old
* Contraindication to colonoscopy at 24 week study time-point

Primary outcomes:
measure: proportion of patients in clinical remission
timeFrame: week 14
Secondary outcomes:
measure: number of new major and minor infections
timeFrame: week 24
measure: number of episodes of nephrotoxicity
timeFrame: week 24
measure: number of episodes of hepatotoxicity
timeFrame: week 24
measure: number of episodes of myelosuppression
timeFrame: week 24
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
Study officials:
affiliation: University of Miami
name: Amar R Deshpande, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04818775: Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
Official title: Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foot Fracture
Ankle Fractures
Ankle Injuries
Foot Injuries and Disorders
Keywords: Foot Fracture
Ankle Fractures
Ankle Injuries
Orthopaedic Devices Associated with Misadventures
Foot Injuries and Disorders
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized controlled trial evaluating the effects of the use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

The trial will randomize 60 patients into an experimental group with HemaClear or Active comparator group with Pneumatic Tourniquet.

The outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet


Eligibility criteria: Inclusion Criteria:

* Ankle and foot surgery

Exclusion Criteria:

* Infection
* Tumors
* Open fracture
* Burns
* Varicose veins
* Isquemia

Primary outcomes:
measure: infection rates
timeFrame: after 1 week
measure: infection rates
timeFrame: after 3 months
measure: Deep vein thrombosis
timeFrame: after 1 week
measure: Deep vein thrombosis
timeFrame: after 3 months
Secondary outcomes:
measure: local pain
timeFrame: after 1 week
measure: local pain
timeFrame: after 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Maurício P Barbosa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432275: Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Official title: Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
SMBG
Insulin calculator
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.

Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.


Eligibility criteria: Inclusion Criteria:

* Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
* Age 18 yrs and above;
* Regularly testing SMBG 3 or more times per day;
* Willingness to test at least 4 times per day.

Exclusion Criteria:

* Know to require a bolus injection of more than 50U in a single dose;
* Has previously used either the InsuLinx or assigned comparison meter;
* Participated in structured diabetes management training in the last 6 months
* Is currently on an insulin pump;
* Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
* Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
* Female subject who is pregnant or planning to become pregnant during the course of the study.

Primary outcomes:
measure: Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
timeFrame: 25 days
Secondary outcomes:
measure: Preference Questionnaire (Insulin Calculator Not Activated)
timeFrame: 25 days (results recorded after the two 7 day periods)
Other outcomes:
Locations:
city: Ashton-under-Lyne
country: United Kingdom
facility: Tameside Hospital NHS Foundation Trust
city: Ayr
country: United Kingdom
facility: Ayr Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Crumpsall
country: United Kingdom
facility: North Manchester Diabetes Centre
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
city: Nottingham
country: United Kingdom
facility: Greenwood & Sneinton Family Medical Centre
Study officials:
affiliation: Royal Blackburn Hospital
name: Shenaz Ramtoola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808275: Caloric Restriction and Body Weight in Adults
Official title: Effect of Dietary Calcium on Body Weight Regulation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: dietary calcium
weight loss
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine the role of

1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
2. caloric restriction on biomarkers of inflammation and oxidative stress


Eligibility criteria: Inclusion Criteria:

* 18 -65 years old
* Healthy

Exclusion Criteria:

* Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
* Heart disease

Primary outcomes:
measure: Fat in stool as a percentage of fat intake
timeFrame: 3 months of diet
Secondary outcomes:
measure: Weight change
timeFrame: 3 months of diet
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Maciej Buchowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
citation: Buchowski MS, Aslam M, Dossett C, Dorminy C, Choi L, Acra S. Effect of dairy and non-dairy calcium on fecal fat excretion in lactose digester and maldigester obese adults. Int J Obes (Lond). 2010 Jan;34(1):127-35. doi: 10.1038/ijo.2009.212. Epub 2009 Oct 13.
Clinical trial NCT00631475: Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Official title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Actelion
Idiopathic Pulmonary Fibrosis
bosentan
Tracleer
Interstitial Lung Disease
BUILD 3 (NCT00391443)
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).


Eligibility criteria: Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.

* Signed informed consent prior to initiation of any study-related procedures.
* Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.

Exclusion Criteria:

* Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
* Pregnancy or breast-feeding.
* AST and/or ALT \> 3 times the upper limit of the normal range.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
* Known hypersensitivity to bosentan or any of the excipients.

Primary outcomes:
measure: Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: Start of study to end of study, up to 21 months
Secondary outcomes:
measure: Number of Patients Exposed to Bosentan Over Time
timeFrame: Start to end of study, up to 21 months
measure: Adverse Events (AE) Leading to Discontinuation of Study Drug.
timeFrame: Start to end of study, up to 21 months
measure: Treatment-emergent Serious Adverse Events (SAE)
timeFrame: up to 21 months plus 28 days after the end of study drug
measure: Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
timeFrame: up to 21 months, plus 24 hours after the end of study treatment
Other outcomes:
Locations:
Study officials:
affiliation: Actelion
name: Isabelle Leconte
role: STUDY_CHAIR
References:
Clinical trial NCT03260075: Effects of Ward Cats in Patients With Substance Abuse, Depression and Psychosis at UPK Basel
Official title: Effects of the Presence of Ward Cats on Patient Satisfaction and Ward Atmosphere for Patients With Substance Abuse, Depression and Psychosis at UPK Basel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction
Station Atmosphere
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients at UPK Basel diagnosed with substance abuse, depression and psychosis as well as staff members working at these wards.

Brief summary: The aim of this study is to explore the relationship between ward cats and patient satisfaction and stations atmosphere in patients with substance abuse, depression and psychosis. Moreover, we wanted to investigate the patients perception of the ward cats and the relationship between station atmosphere perceived by the employees working wards with and without cat at UKP Basel.

Detailed description: The following tools were used to address these aims:

* Available MüPF data regarding patient satisfaction of 170 inpatients during 2016 was analyzed.
* Available MüPF data regarding patient satisfaction of 151 inpatients during 2017 was analyzed.
* 33 patients were interviewed regarding their perception of the cats
* 30 staff members at the wards filled in questionnaires regarding station atmosphere (EssenCES)

Eligibility criteria: Inclusion Criteria:

* Inpatient of the 7 wards at UPK Basel diagnosed with substance abuse, depression and psychosis
* staff working at these wards

Exclusion Criteria:

* none

Primary outcomes:
measure: Patient satisfaction (MüPF)
timeFrame: August - Sept 2017
Secondary outcomes:
measure: station atmosphere
timeFrame: August - Sept 2017
measure: Patient satisfaction (interview)
timeFrame: August - Sept 2017
measure: Patients perception of cats
timeFrame: August - Sept 2017
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken Basel
Study officials:
affiliation: University of Basel
name: Karin Hediger, Dr.
role: PRINCIPAL_INVESTIGATOR
References: