louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01399671: Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in Major Depression
Official title: Clinical Randomized Trial to Evaluate the Efficacy of Vestibular Stimulation as Coadjuvant Therapy in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Major Depression
Vestibular Disorders
Keywords: depression
vestibular
Lead sponsor: Fuerza Aérea de Chile
Sponsor class: OTHER_GOV
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2011-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depression is characterized by vestibular anomalies. The investigators hypothesized that vestibular stimulation will improve depression symptoms in major depression patients.


Eligibility criteria: Inclusion Criteria:

* major depression patients,
* actual Hamilton score \> 14

Exclusion Criteria:

* pregnant,
* neurological disorders,
* epilepsy,
* bipolar disorder,
* schizophrenia,
* anorexia,
* bulimia.

Primary outcomes:
measure: Hamilton depression rating score
timeFrame: 1 month after the treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Medicina Aeroespacial
state: Región Metropolitana
Study officials:
affiliation: Fuerza Aerea de Chile
name: Ana M Soza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184871: Next Generation Sequencing in Intrahepatic Cholangiocarcinoma
Official title: Next Generation Sequencing in Intrahepatic Cholangiocarcinoma (ICC) According to the Stratification of the Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
RNAseq
risk factors
asbestos
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 45
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: ICC patients candidate for curative-intent surgery, for a total of 45 subjects. For each patient enrolled, histological examination of tumor tissue specimen will be performed in order to confirm ICC diagnosis.

Brief summary: The aim of the present study is to perform a comprehensive molecular characterization of intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk factors (such as asbestos) for this malignancy, in order to identify possible "molecular signatures" associated to such different risk factors.

Detailed description: Exposure to distinct risk factors of the enrolled ICC patients will be assessed by modified ReNaM questionnaire. Molecular characterization of ICC tissue samples will be carried out by RNAseq. Briefly, after surgical resection tissue samples will be immediately suspended in RNAlater. RNAseq analysis will be performed on the Illumina HiScanSQ platform. Any possible mutations identified by RNAseq will be validated by Sanger sequencing. Putative identified fusion transcripts will be confirmed by RT-PCR, using specific primers pairs located on the sequences from the exons of the two putative fusion genes. Variations in gene expression will be validated by the real-time PCR. The bioinformatic analysis will be made by using CentOS5 Server. For evaluation of asbestos fibers in tumor tissues, samples embedded in paraffin will be incinerated and then analyzed in a scanning electron microscope and by EDS spectroscopy.

Eligibility criteria: Inclusion Criteria:

* patients having a confirmed diagnosis of ICC resected;
* patients who have signed the informed consent;
* patients (males or females) who are at least 18 years old.

Exclusion Criteria:

* patients who have been treated with any medical treatment (chemotherapy or experimental standard) or with radiotherapy during the last 5 years.

Primary outcomes:
measure: Identification of molecular biomarkers in ICC patients exposed to different risk factors.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola- Malpighi, S.S.D. Oncologia Medica- Biasco
state: BO
Study officials:
affiliation: University of Bologna
name: Giovanni Brandi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05726071: Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease
Official title: Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predialytic Chronic Kidney Disease
Keywords: Chronic kidney disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children with predialytic chronic kidney disease

Brief summary: CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after

Detailed description: This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia

Eligibility criteria: Inclusion Criteria:

Age 1 to 15 year children with predialytic chronic kidney disease GFR.\>15 ml\\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages).

Exclusion Criteria:

* Age \>15 year On regular dialysis GFR\<15 ml\\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant

Primary outcomes:
measure: Heart rate variability
timeFrame: One year
measure: changes in QT interval
timeFrame: One year
measure: QRS duration
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
References:
citation: Shafi S, Saleem M, Anjum R, Abdullah W, Shafi T. ECG Abnormalities In Patients With Chronic Kidney Disease. J Ayub Med Coll Abbottabad. 2017 Jan-Mar;29(1):61-64.
citation: Park S, Yum Y, Cha JJ, Joo HJ, Park JH, Hong SJ, Yu CW, Lim DS. Prevalence and Clinical Impact of Electrocardiographic Abnormalities in Patients with Chronic Kidney Disease. J Clin Med. 2022 Sep 15;11(18):5414. doi: 10.3390/jcm11185414.
citation: Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
Clinical trial NCT01839071: Influence of Vasculary Inflammation on Development of Diabetes
Official title: Influence of Vasculary Inflammation on Development of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease(CAD)
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate if patients with coronary heart disease have higher risk to develop diabetes mellitus among the following two years.

The examination of biomarkers taken from blood and fat issue shall provide which factors could be responsible for development of diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* all patients with MI
* signed informed consent
* older than 18 years
* ability to give informed consent

Exclusion Criteria:

* absence of legal competence

Primary outcomes:
measure: Fat tissue biopsy
timeFrame: 2 years
Secondary outcomes:
measure: Blood collection
timeFrame: 2 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
state: North Rhine Westfalia
Study officials:
References:
Clinical trial NCT01272271: Safety of Overnight Corneal Reshaping Lenses
Official title: Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratitis
Myopia
Keywords: Contact lens
Infection
Cornea
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
name: CooperVision, Inc.
First posted: 2011-01-07
Enrollment: 1317
Sex: ALL
Minimum age (years): 5
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.

Brief summary: This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.


Eligibility criteria: Inclusion Criteria:

* Patients completing at least 3 months of wearing corneal reshaping lenses

Exclusion Criteria:

* Less than 3 months of wearing corneal reshaping lenses

Primary outcomes:
measure: Microbial keratitis incidence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Mark A Bullimore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795171: Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Official title: Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hormone Refractory Prostate Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients

Detailed description: Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.

We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.

Eligibility criteria: Inclusion Criteria:

* WHO performance status of 0-2.
* Histologically proven prostate adenocarcinoma.
* All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
* Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:

  * 25% increase in bidimensionally measurable soft tissue metastases
  * Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)
  * PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
* If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization

Exclusion Criteria:

- prior chemotherapy for prostate cancer

Primary outcomes:
measure: Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Response rate and length of treatment holidays relative to docetaxel monotherapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept of Internal Medicine
Study officials:
affiliation: Dept of Internal Medicine I, Medical University Vienna, Austria
name: Michael MK Krainer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02418871: Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System
Official title: Clinical Evaluation of the FluidVision Accommodating Intraocular Lens With an Improved Injector System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: Cataract
Lead sponsor: PowerVision
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 53
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.


Eligibility criteria: Key Inclusion Criteria:

* Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
* Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
* Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
* Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
* Taking systemic medications that may confound the outcome or increase the risk to the subject;
* Ocular conditions that may predispose for future complications;
* Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
* Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Accommodative amplitude
timeFrame: Month 6
measure: Best corrected distance visual acuity (BCDVA)
timeFrame: Month 6
measure: Rates of adverse events
timeFrame: Up to Month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: PowerVision Investigative Site
city: Claremont
country: South Africa
facility: PowerVision Investigative Site
state: Cape Town
city: Northcliff
country: South Africa
facility: PowerVision Investigative Site
state: Johannesburg
city: Queenswood
country: South Africa
facility: PowerVision Investigative Site
state: Pretoria
city: Somerset West
country: South Africa
facility: PowerVision Investigative Site
Study officials:
References:
Clinical trial NCT02827071: Ocular Imaging Study Using Advanced OCT
Official title: Ocular Imaging Study Using Advanced OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Vascular Disorder
Macular Degeneration
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with retinal vascular abnormalities

Brief summary: The purpose of this study is to evaluate this AngioScan angiography software on patients with various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically used camera, but the AngioScan angiography software is not FDA approved. Investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. Images collected in this study may be compared to other images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).


Eligibility criteria: Inclusion Criteria:

• Any patient with abnormal retinal findings as determined by investigators.

Exclusion Criteria:

* Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging.
* Participants who are unable to maintain retinal fixation on a specified target.
* Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place.
* Patients with media opacity which preclude high quality imaging.

Primary outcomes:
measure: Retinal vascular abnormalities imaged by OCT Angiography and en face analysis of macular disorders
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Stein Eye Institute/Geffen School of Medicine
state: California
Study officials:
References:
Clinical trial NCT05835271: Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease
Official title: Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Disease Chronic
Keywords: Walking
Exoskeleton Device
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective longitudinal, self-controlled, single-case repeated measures alternating treatment, randomized and counterbalanced cross-over experimental trial design, comparing walking endurance without and with a powered exoskeleton.
Primary purpose: TREATMENT

Brief summary: Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered hip exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.


Eligibility criteria: Inclusion Criteria:

* stable chronic respiratory disease
* modified medical research council dyspnoea score (mMRC) ≥ 2

Exclusion Criteria:

* evidence of cardiac rhythm or circulatory compromise
* myocardial infarct within the previous three months
* moderate-severe aortic stenosis
* uncontrolled hypertension
* sustained cardiac arrhythmias
* untreated neoplasia
* lung surgery within the previous three months
* any other predominant co-morbidities or treatments that might influence walk testing
* body size outside of exoskeleton fit specifications
* skin sores or skin breakdown in the area where the device is worn
* a high risk of fracture

Primary outcomes:
measure: walking endurance time
timeFrame: an average of 7 tests over 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Westpark Health Care Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available.
Clinical trial NCT01023971: Macular Function During Anti-VEGF Treatment
Official title: Study of Macular Function During Anti-VEGF Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age Related Macular Degeneration
Lead sponsor: Royal Liverpool University Hospital
Sponsor class: OTHER_GOV
First posted: 2009-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AMD clinic

Brief summary: The purpose of this study is to determine the changes in macular function during anti-VEGF treatment for neovascular age-related macular degeneration.

Detailed description: Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.

Eligibility criteria: Inclusion Criteria:

* Neovascular AMD in first or second eyes
* angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV)
* BCVA ≥35 ETDRS letters

Exclusion Criteria:

* Spherical equivalent ≥ ± 6 D
* Previous treatments for CNV in the studied eye

Primary outcomes:
measure: mfERG central ring amplitude density
timeFrame: 12 months
Secondary outcomes:
measure: Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°)
timeFrame: 12 months
measure: Choroidal blood flow (ChBFlow) at fovea and at optic nerve head
timeFrame: 12 months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Clinical Eye Research Centre
Study officials:
affiliation: University of Liverpool
name: Simon P HARDING, FRCOphth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campa C, Hagan R, Sahni JN, Brown MC, Beare NA, Heimann H, Harding SP. Early multifocal electroretinogram findings during intravitreal ranibizumab treatment for neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3446-51. doi: 10.1167/iovs.10-6588.