louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03310788: Monitoring of the IOP After SLT Using iCare Home
Official title: Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma Open-Angle Primary
Pseudo Exfoliation Syndrome
Keywords: IOP fluctuations
iCare Home
SLT
self-tonometry
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a SLT.

Brief summary: The purpose of this study is to investigate how much selective trabeculoplasty (SLT) influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Detailed description: Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer, a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. Thereafter, a new measurement will be obtained by the study staff (an optometrist or a nurse) using the same device. No IOP values will be visible for the examiner at that point. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.

Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

Eligibility criteria: Inclusion Criteria:

* POAG
* PXG

Exclusion Criteria:

* previous SLT
* reduced hand and arm mobility (e.g. due to rheumatism)

Primary outcomes:
measure: Lowering of IOP fluctuations after SLT
timeFrame: 2 months
Secondary outcomes:
measure: Lowering of IOP level after SLT
timeFrame: 2 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Erik Eye Hospital
Study officials:
affiliation: St. Erik Eye Hospital
name: Enping Chen, MD Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00680888: Adherence in Adolescents and Children Treated on Quetiapine
Official title: Adherence in Adolescents and Children Treated on Quetiapine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Keywords: Psychosis
adolescents
adherence
quetiapine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006

Brief summary: Observational study aimed to describe the adherence in a population of adolescents and children treated on quetiapine from a first psychotic episode whose more important secondary objective is to identify possible predictive factors influencing the adherence to treatment with Quetiapine


Eligibility criteria: Inclusion Criteria:

* At least one psychotic symptom (delusions or hallucinations) before age 18.
* Start of treatment in a maximum period of 2 years after the onset of first psychotic symptom
* Written informed consent by parents or guardians and patients.

Exclusion Criteria:

* Pregnancy or lactancy
* High risk of aggression or suicidal behaviour
* Alcohol dependence

Primary outcomes:
measure: Survival analysis of rate of adherence to treatment on quetiapine
timeFrame: 6 months
Secondary outcomes:
measure: Survival analysis of rate of adherence to treatment on quetiapine
timeFrame: 12 months
measure: Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence
timeFrame: 0, 6, 12 months
measure: Tolerability profile (UKU) possibly influencing adherence
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04333888: A Neurofeedback Booster for Emotion Regulation Therapy
Official title: BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: Yale University
name: AE Foundation
First posted: 2020-04-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a proof-of-concept study that aims to test the additional value of adjuvant neurofeedback treatment for psychotherapy. Three sessions of real-time fMRI neurofeedback will be administered to N=22 patients with BPD while they receive residential Dialectical Behavior Therapy treatment. In addition, outcomes are assessed from a control group with same sample size who do not receive the treatment.


Eligibility criteria: Inclusion Criteria:

* DSM-5 BPD diagnosis
* informed consent
* EtOH and tox negative on the day of neurofeedback
* BSL-23 score \>=1.87 at DBT halftime

Exclusion Criteria:

* pharmacotherapy with opiates
* standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
* pregnancy
* epilepsy
* life-time diagnosis schizophrenia or bipolar disorder I
* significant current or past neurological illness
* BMI\<16.5
* usual safety criteria for magnetic resonance imaging

Primary outcomes:
measure: Change in affective instability
timeFrame: Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary outcomes:
measure: Change in emotion regulation
timeFrame: Before treatment, immediately after treatment + follow-up measure (3 months)
measure: Change in borderline symptomatology
timeFrame: Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)
measure: Change in resting state brain connectivity
timeFrame: Before treatment, immediately after treatment + follow-up measure (3 months)
measure: Change in amygdala reactivity
timeFrame: Before treatment, immediately after treatment + follow-up measure (3 months)
measure: Structural changes in the brain
timeFrame: Before the first neurofeedback training and after the last neurofeedback training
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
References:
citation: Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.
Clinical trial NCT02378688: Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
Official title: A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 78
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: The primary objectives of the study are:

* To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
* To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CD (involving small intestine and/or colon), confirmed by both endoscopy and histopathology at least 3 months prior to Visit 1
* Previous use of any type of corticosteroids or immunosuppressants for the treatment of CD
* Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease
* Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study
* GI surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study

Primary outcomes:
measure: Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12)
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: City Name
country: Czech Republic
facility: Investigational site
city: City Name
country: France
facility: Investigational site
city: City Name
country: Germany
facility: Investigational Site
city: City Name
country: Hungary
facility: Investigational site
city: City Name
country: Israel
facility: Investigational site
city: City Name
country: Italy
facility: Investigational site
city: City Name
country: Japan
facility: Investigational site
city: City Name
country: Netherlands
facility: Investigational site
city: City Name
country: Poland
facility: Investigational site
city: City Name
country: Slovakia
facility: Investigational site
city: City Name
country: Ukraine
facility: Investigational site
Study officials:
References:
Clinical trial NCT00852488: Medium-term Venous Access in Congenital Heart Surgery
Official title: A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.


Eligibility criteria: Inclusion Criteria:

* Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy
* Age 0-365 days
* Anticipated intensive care stay over 10 days
* Need for central venous access or prolonged venous access

Exclusion Criteria:

* Presence of access that is likely to last more than 10 days at time of operation
* Septic shock
* Known inferior vena cava thrombosis
* Operations not approached by sternotomy

Primary outcomes:
measure: Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.
timeFrame: Until catheter no longer needed; it is not anticipated that these remain longer than 2 weeks. Prior to discharge all will have been removed and final assessment of primary outcome will be obtained
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David P Bichell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597488: EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
Official title: EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis Portal
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 75 years old
* Informed consent available
* Suffering from chronic hepatitis induced cirrhosis
* Suffering from oesophageal varices and received EVL as a result of

  1. Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
  2. Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
* Or bleeding gastric varices that have received endoscopic canoacrylate injection

Exclusion Criteria:

* Medical Child-Pugh Class C Uncorrected platelet count \<50,000 INR \> 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
* Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).

Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation

- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.

Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers

Primary outcomes:
measure: Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
timeFrame: 1 year
Secondary outcomes:
measure: Other outcome measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
Study officials:
References:
Clinical trial NCT03573388: OCT Measures Predicting FFR
Official title: OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Intermediate coronary lesions
Fractional flow reserve
Optical coherence tomography
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion

Brief summary: Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique.

Objectives:

1. Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
2. Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.

Study design: multicentre, international, individual patient's level data pooled analysis.

Detailed description: Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.

Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with angiographically-intermediate coronary lesion
* Patients who underwent both FFR and OCT assessment of the same lesion

Primary outcomes:
measure: OCT measures predicting FFR - mean lumen area
timeFrame: 1 day
measure: OCT measure predicting FFR - area stenosis
timeFrame: 1 day
measure: OCT measure predicting FFR - thrombus or ulceration
timeFrame: 1 day
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG)
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Study officials:
References:
Clinical trial NCT01377688: Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
Official title: Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Kidney Disease
Keywords: DKD
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetics with progressive kidney disease

Brief summary: We propose to pilot a telehealth approach to evaluate components of risk communication by:

1. Providing personalized tailored patient feedback to help initiate and maintain specific diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight, exercise, diet, smoking cessation) to reduce their risks.
2. Evaluating how this feedback can be incorporated into clinical care by examining 6 month patient outcomes.

Specific Aims are:

1. To evaluate the feasibility and acceptability of providing both patients and their provider feedback on individuals' DKD risk via the telehealth intervention and incorporating it into regular clinical practice.
2. If improvements in outcomes are found, to estimate the cost of the program in terms of the patient, provider, and overall costs of implementing the program.

Detailed description: We propose an innovative telehealth approach that has reduced antecedents of kidney disease, including poor blood pressure and glucose control, but has never been used to treat DKD. To mitigate the growing burden of DKD, these studies are designed to determine whether a potentially scalable, telehealth intervention effectively slows progression of DKD in a diverse US population and whether it is also cost-effective. The intervention simultaneously addresses medication management and behavioral therapies and education that seek to optimize adherence and self-efficacy. This proposed pilot trial will begin to evaluate if a multifactorial telehealth intervention may be effective in reducing progression of DKD.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes with progressive kidney disease

Exclusion Criteria:

* Metastatic cancer
* Dementia
* Psychosis
* No Access to phone
* Diagnosis of non-diabetic kidney disease

Primary outcomes:
measure: Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Universtiy Medical Center
name: Hayden B Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384888: Neurostimulation Applied to Fibromyalgia
Official title: Neurostimulation Applied to Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Neurostimulation, TDCS
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 59
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
Primary purpose: TREATMENT

Brief summary: NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
* (2) been diagnosed for at least three months;
* (3) be female;
* (4) be in the age group between 25 and 60 years of age; and
* (5) sign the consent form.

Exclusion Criteria:

* (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
* (2) illiterate;
* (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
* (4) history of convulsion;
* (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
* (6) be pregnant.

Primary outcomes:
measure: Pain intensity level
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary outcomes:
measure: Quality of life level
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Health assessment level
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Sleep quality
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Cognitive function
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Anxiety level
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Depression level
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Cortical electrical activity
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
measure: Resilience
timeFrame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Universidade Federal da Paraiba
state: Paraíba
Study officials:
References: