louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02336100: Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis
Official title: Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: Diagnostic technique and procedure
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were analyzed.

Detailed description: Thirty-six patients with suspected MERD (positive GerdQ but normal conventional endoscopy) and eighteen asymptomatic control were recruited. The new FICE (EPX-4450HD) was performed at non-magnified, x50, and x100 zoom levels. The criteria for positive FICE were; A) triangular indentation, B) punctuate erythema, C) villiform mucosa, or D) increased number of capillary vessel. At the same session, pCLE was applied to count the number of intrapapillary capillary loops (IPCLs) by using more than 5 IPCLs in 500x500 micron area as a criterion for MERD diagnosis. The validity scores of both modalities and interobserever agreement of pCLE interpretation was assessed.

Eligibility criteria: Inclusion Criteria:

1. age more than 18 year old
2. no PPI therapy in previous 2 weeks and
3. no esophageal tumor or stenosis or history of esophageal surgery.

Exclusion Criteria:

1. bleeding tendency including decompensated cirrhosis, chronic kidney disease
2. long term antiplatelets or anticoagulants,
3. pregnancy or
4. history of fluorescein allergy.

Primary outcomes:
measure: MERD diagnosis from FICE plus pCLE.
timeFrame: 8 months
measure: Interobserver agreement in pCLE for MERD diagnosis
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Patum Wan
Study officials:
affiliation: king
name: Rapat Pittayanon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02187900: Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
Official title: Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: IgA Nephropathy
Keywords: Tripterygium Wilfordii HOOK. f.
Mycophenolate mofetil
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
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 whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.

Detailed description: Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deﬁcient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy

Eligibility criteria: Inclusion Criteria:

* urinary protein levels ≥1.0 g/24 h
* estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
* 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
* peripheral blood white blood cell count ≥3000×109/L
* no other cause for tubulointerstitial lesions
* no history of immunomodulatory agent intake before renal biopsy
* no systemic infection
* age between 16 and 65 years

Exclusion Criteria:

* severe infections

Primary outcomes:
measure: Number of patients reaching remission
timeFrame: one year
Secondary outcomes:
measure: Renal survival
timeFrame: one year
Other outcomes:
measure: adverse event
timeFrame: one year
Locations:
city: Changsha
country: China
facility: The second Xiangya Hospital of CSU
state: Hunan
Study officials:
affiliation: the second xiangya hospital of CSU
name: Shenghua Zhou, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03536052: Ablation at Virtual-hEart pRedicted Targets for VT
Official title: Ablation at Virtual-hEart pRedicted Targets for VT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Ischemic Cardiomyopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the efficacy of the new imaging/simulation ("virtual heart") approach for determining the optimal ablation sites in patients with VT, which render post-infarction VT non-inducible. The study will test both the acute outcome of the ablation procedure, and the effect the use of the predicted targets has upon procedure time.


Eligibility criteria: Inclusion Criteria:

* Eligible patients must be at least 18 years old at the time of enrollment.
* A Pre-Op cardiac MRI including late gadolinium enhancement (LGE) must be performed prior to ablation. As Johns Hopkins University (JHU) performs MRIs with implantable cardioverter defibrillator (ICD) or pacemaker implanted, patients with these devices may be enrolled.
* Eligible patients must suffer from VT, thought to be secondary to structural heart disease (scarring).
* Eligible patients must be determined to be suitable candidates for ablation to treat VT by their cardiologist and/or electrophysiologists regardless of this protocol.

Exclusion Criteria:

* Patients with Glomerular Filtration Rate (GFR) \< 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent
* If a pre-procedure MRI cannot or likely will not be performed for any reason (such as claustrophobia), the patient must be excluded.
* Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in these patients.
* Any subject that, during the course of the pre-procedure imaging, is discovered to have VT not related to scarring, he/she must be de-enrolled from the study.

Primary outcomes:
measure: Ventricular Tachycardia Inducibility
timeFrame: time of procedure
Secondary outcomes:
measure: Freedom from Ventricular Tachycardia
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathan Chrispin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265252: Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Official title: Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Traumatic Osteonecrosis
Keywords: osteonecrosis
total hip replacement
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Cheng-Kung University Hospital
name: National Taiwan University Hospital
First posted: 2005-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid

Detailed description: To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid

Eligibility criteria: Inclusion Criteria:

* osteonecrosis of femoral head
* be able to provide singed informed consent

Exclusion Criteria:

* prior bisphosphonate use
* pregnant or lactating woman
* bilateral hip replacement

Primary outcomes:
measure: the cumulative of total hip replacement
Secondary outcomes:
measure: necrotic area
measure: Harris hip score
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Gwo-Jaw Wang, MD
role: STUDY_CHAIR
References:
citation: Lai KA, Shen WJ, Yang CY, Shao CJ, Hsu JT, Lin RM. The use of alendronate to prevent early collapse of the femoral head in patients with nontraumatic osteonecrosis. A randomized clinical study. J Bone Joint Surg Am. 2005 Oct;87(10):2155-9. doi: 10.2106/JBJS.D.02959.
citation: Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.
Clinical trial NCT05461352: Long-Term Study of TS-142 in Patients with Insomnia
Official title: A Multi-center, Open-label Long-Term Study of TS-142 in Patients with Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients with Insomnia
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, multi-center long-term study in patients with insomnia.


Eligibility criteria: Inclusion Criteria:

1. Japanese male and female who are aged 18 years or older at the time of informed consent
2. Outpatients
3. Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
2. Patients with psychiatric diseases other than depression and anxiety
3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep

Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From start of investigational drug administration to final test and observation; up to approximately 1 year
Secondary outcomes:
measure: Mean change from baseline of subjective sleep latency (sSL)
timeFrame: From baseline up to Week 52
measure: Mean change from baseline of subjective sleep efficacy (sSE)
timeFrame: From baseline up to Week 52
measure: Mean change from baseline of subjective total sleep time (sTST)
timeFrame: From baseline up to Week 52
measure: Mean change from baseline of subjective wake time after sleep onset (sWASO)
timeFrame: From baseline up to Week 52
measure: Mean change from baseline of subjective number of awakenings (sNAW)
timeFrame: From baseline up to Week 52
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01511952: A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Official title: A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Sepsis
SGA
RDS
Keywords: music therapy
entrainment
premature infants
live music intervention
parent preferred lullabies
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 272
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multi-site study of 272 premature infants \>32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.


Eligibility criteria: Inclusion Criteria:

Premature infants diagnosed with SGA, RDS and/or Sepsis \>32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing

Exclusion Criteria:

Infants with diagnoses other than the above

Primary outcomes:
measure: The effects of live music intervention on premature baby function
timeFrame: over two weeks intervention periods
Secondary outcomes:
measure: Vitals
timeFrame: 10 mins before, during and after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Medical Center
name: Joanne V Loewy, DA, MT-BC, LCAT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04862052: Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
Official title: OPtimal TrEatment for CoroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - the OPEN ISR Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Stent Restenosis
Keywords: drug eluting stent
restenosis
drug coated balloon
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).

These are the:

* Magic Touch - sirolimus coated balloon
* Emperor - paclitaxel and dextran coated balloon
* Xience - chromium-cobalt everolimus eluting stent


Eligibility criteria: Inclusion Criteria:

* Patients admitted for intervention of drug eluting stent restenosis
* Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices
* Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)

Exclusion Criteria:

* Patients undergoing coronary angiography after sudden cardiac death
* Pregnant or nursing

Primary outcomes:
measure: Occurrence of new onset target vessel myocardial infarction
timeFrame: 6 months
measure: Occurrence of target vessel revascularization of failure
timeFrame: 6 months
measure: Occurrence of target lesion revascularization
timeFrame: 6 months
Secondary outcomes:
measure: Percentage late lumen loss
timeFrame: 6 months
measure: Percentage intraluminal gain after treatment
timeFrame: index procedure
measure: Square millimetre intraluminal gain after treatment
timeFrame: index procedure
measure: Percentage intraluminal gain after treatment
timeFrame: 6 months
measure: Square millimeter intraluminal gain after treatment
timeFrame: 6 months
measure: Endothelium coverage in micrometers
timeFrame: 6 months
measure: Late lumen loss in square millimetres
timeFrame: 6 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Department of Invasive Cardiology
state: Csongád-Csanád
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
affiliation: Semmelweis University Heart and Vascular Center
name: István F Édes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.
Clinical trial NCT00880152: Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Official title: Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Keywords: stress
mindfulness
trauma
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Puget Sound Partners for Global Health
First posted: 2009-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PTSD is a common consequence of war, for soldiers and civilians. PTSD results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. Within health care, mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR). MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder.

Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans with PTSD to complete a study protocol that involves randomization to usual care or usual care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether MBSR warrants further study for PTSD, and allow calculation of standardized effect sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4: Explore the relationship between PTSD symptoms, mindfulness score, and frequency of meditation practice.


Eligibility criteria: Inclusion Criteria:

* Must have PTSD

Exclusion Criteria:

* Active substance use
* Active suicidal ideations
* Borderline or antisocial personality disorder

Primary outcomes:
measure: PTSD symptom score
timeFrame: baseline, after MBSR and 4 months later
Secondary outcomes:
measure: depression (PHQ9)
timeFrame: baseline, after MBSR and 4 months later
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: David Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kearney DJ, McDermott K, Malte C, Martinez M, Simpson TL. Effects of participation in a mindfulness program for veterans with posttraumatic stress disorder: a randomized controlled pilot study. J Clin Psychol. 2013 Jan;69(1):14-27. doi: 10.1002/jclp.21911. Epub 2012 Aug 28.
Clinical trial NCT03632252: Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time
Official title: Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amputation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to determine a quick, accurate and unobtrusive way to optimize the performance of powered assistive devices like ankle exoskeleton or prostheses.

Detailed description: Lower limb assistive robotic devices, such as active prosthesis, orthoses, and exoskeletons have the potential to restore function for the millions of Americans who experience mobility challenges due to injury and disability. Since individuals with mobility challenges have an increased metabolic costs of transport, the benefit of such assistive devices is commonly assessed via the reduction in the metabolic work rate of the individual who is using the device. Currently, metabolic work rate can only be obtained in a laboratory environment, using breath-by-breath measurements of respiratory gas analysis. To obtain a single steady state data point of metabolic work rate, multiple minutes of data must be collected, since the signals are noisy and slow. In addition, the user has to wear a mask and bulky equipment. The investigators propose an improved way to obtain such estimates of metabolic work rate in real-time. In this project, the investigators will use various small sensors to optimize push-off timing for an active ankle prosthesis.

Eligibility criteria: Inclusion Criteria:

* Has a unilateral amputation
* Has used a prosthesis for at least 6 months

Exclusion Criteria:

* History of orthopedic or neurologic disorders to their intact limb
* History of cardiovascular disease
* Unable to walk for 30 minutes at a time

Primary outcomes:
measure: Minimum metabolic cost
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Deanna H Gates, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: C D Remy, PhD
role: PRINCIPAL_INVESTIGATOR
References: