louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01897181: Central Auditory Processing and the Use of Hearing Aids
Official title: Evaluation of the Central Auditory Processing in Patients (Elder Than 45 Years Old) With Bilateral Sensorineural Hearing Loss and the Change of the Central Auditory Processing Ability by the Use of Hearing Aids (CAPHA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Processing Disorder, Central
Keywords: Central auditory processing
Bilateral sensorineural hearing loss
Hearing aids
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the central auditory processing in patients with bilateral sensorineural hearing loss and to observe the change of the central auditory processing ability after using hearing aids.

Detailed description: Screening for recruiting

* Among patients who are visiting for hearing disturbance, patients with bilateral sensorineural hearing loss will be included after audiologic tests, history taking and physical examination.
* audiologic tests: pure tone audiometry, speech audiometry, impedence audiometry, distortion product otoacoustic emission, auditory brainstem response.

Dividing into "Hearing aids" group and "No hearing aids" group

* The use of hearing aids will be recommended to all included patients.
* Hearing aids group: patients who want to be prescribed hearing aids (28 subjects)
* No hearing aids group: patients who do not want to be prescribed hearing aids (28 subjects)

Audiologic test

* Hearing in noise test (HINT), central auditory processing disorder test
* at screening, 1, 3, 6, 9 and 12 months after starting hearing aids use

Eligibility criteria: Inclusion Criteria:

* Adults of age 45 years of older
* Bilateral sensorineural hearing loss
* Average pure tone audiometry threshold \>= 40dB
* Speech discrimination \>= 60% in both ears

Exclusion Criteria:

* Refusing the study
* Medical history of any brain damage or intracranial surgery
* Showing signs of central lesion in MRI or neurologic exams
* Speech discrimination \< 60% in any ear

Primary outcomes:
measure: Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
timeFrame: at screening and 6 months after starting hearing aids use
Secondary outcomes:
measure: changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months
timeFrame: at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use
measure: changes from the baseline in the HINT score at 3, 9, and 12 months
timeFrame: baseline, 3, 9 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jong Woo Chung, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00269581: Headstrong Intervention for Pediatric Headache
Official title: Headstrong Intervention for Recurrent Pediatric Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Headaches
Keywords: migraine
tension headaches
chronic daily headaches
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2005-12-23
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.

Detailed description: Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM program or the Headstrong CD-ROM program. We anticipate that those assigned to the active (Headstrong) program group will have significantly greater reductions in headache frequency, duration, and severity and improvements in mood and quality of life.

Eligibility criteria: Inclusion criteria:

* 7-12 years of age
* having recurrent, intermittent, nonmalignant headaches occurring on an average of at least once per week by parental or child report and separated by symptom-free periods
* having a diagnosis by a nurse practitioner, pediatrician, or pediatric neurologist of migraine, muscle-contraction, or chronic daily headaches

Exclusion criteria:

* their medical history and/or neurological exam suggests that headaches are secondary to another physical or developmental condition
* their parents report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy
* their baseline headache diaries indicate an average headache frequency of less than one per week

Primary outcomes:
measure: Pain, mood, and stress self-rating scales
timeFrame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
measure: Headache-related disability
timeFrame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Children's Mercy Hospital Kansas City
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Michael Rapoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04221581: Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device
Official title: Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Disease
Keywords: Knee
Arthroplasty
Replacement
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 43
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: Patients from participating hospitals will be enrolled as part of their clinical routine care

Brief summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.

Detailed description: The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Adults subjects (≥18 years old).
* Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
* Subject who received an information form and is willing to participate in the study.

Exclusion Criteria:

* Contraindications described in the instructions for use
* Usual surgical contraindications
* Patients objecting to participate in this study
* Subject who is not able to express his/her non-opposition

Primary outcomes:
measure: Safety evaluation
timeFrame: 10 years post-op
Secondary outcomes:
measure: Radiological evaluation
timeFrame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
measure: Rate of complications
timeFrame: peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
measure: Functional outcomes such as pain, mobility.
timeFrame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Other outcomes:
Locations:
city: Colmar
country: France
facility: CH Pasteur
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de l'Orient
city: Toulouse
country: France
facility: Médipôle Garonne
Study officials:
References:
Clinical trial NCT01680081: Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study was designed as a prospective multicenter trial to determine the accuracy of combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic perfusion imaging in patients with suspicious coronary artery disease compared conventional coronary angiography and quantitative dynamic perfusion MRI as standard reference.


Eligibility criteria: Inclusion Criteria:

1. Men and women patients, with age ranging 40-80.
2. Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications
3. Patients who are willing to sign the informed consent form

Exclusion Criteria:

1. Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(\>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
2. Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR\<30 ml/min
3. Unstable or uncooperative patients
4. Limited life expectancy due to cancer or end-stage renal or liver disease
5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)
6. Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery

Primary outcomes:
measure: Diagnostic accuracy of stress induced CT perfusion
timeFrame: 10-30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT01228981: Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy
Official title: Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type-2 Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
Collaborators: name: University of Coimbra
First posted: 2010-10-27
Enrollment: 400
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: Type-2 diabetic subjects in the early stages of non-proliferative retinopathy (level 30 to 35 ETDRS) included in the clinical trial "Validation of a predictive model to estimate the risk of conversion to clinically significant macular edema and/or vision loss in mild nonproliferative diabetic retinopathy in diabetes type 2" (Protocol number: PTDC/SAU-OSM/72635/2006; ongoing at AIBILI Clinical Trial Center).

Brief summary: The purpose of this study is to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously identified and different patterns of progression in order to correlate this data with genetic information.

Detailed description: This study aims to to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on three different phenotypes previously identified and different patterns of progression \[Lobo, 2004\] in order to correlate this data with genetic information (based on a list of candidate genes previously identified as being involved in DR).

The results of this study will be used exclusively for scientific purposes.

Eligibility criteria: Inclusion Criteria:

* Type-2 diabetic subjects form the PTDC/SAU-OSM/72635/2006 clinical trial (early stages of non-proliferative retinopathy - level 30 to 35 ETDRS;. females or males; age over 18 years) with a signed Informed Consent for this study.

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations; Vitreous syneresis or posterior vitreous detachment; and Dilatation of the pupil \< 5 mm.

Primary outcomes:
measure: Phenotypes of Diabetic Retinopathy progression.
timeFrame: June 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI - Clinical Trials Center
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Conceição Lobo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunha-Vaz J, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.
Clinical trial NCT05859581: The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer
Official title: To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: Colon cancer
MRI
Resection margin
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 29
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: The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer.

The main questions it aims to answer are:

* Concordance between MRI suspected RPRM positive and pathologically confirmed positive.
* Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection?

Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.


Eligibility criteria: Inclusion Criteria:

* primary colon adenocarcinoma confirmed by biopsy
* preoperative CT suspecting retroperitoneal resection margin (RPRM) positive
* received colon MRI scan
* underwent beyond complete mesocolic excision surgery
* sufficient clinical and pathological results

Exclusion Criteria:

* combined with other malignant tumors
* simultaneous distant metastasis
* definite invaded other organs or structures (T4b tumors)

Primary outcomes:
measure: Coincidence rate with pathological result
timeFrame: within 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ying-Shi Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01225081: A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone in Type 2 Diabetic Patients
Official title: A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: ASP1941
Diabetes mellitus
pioglitazone
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.

Detailed description: This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks
* HbA1c value between 7.0 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
* Heart failure patients

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline and for 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: Baseline and for 24 weeks
measure: Change from baseline in fasting serum insulin
timeFrame: Baseline and for 24 weeks
measure: Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: For 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
Clinical trial NCT02202681: Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Official title: Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Celiac Disease
Healthy
Keywords: Duodenum
Optical Frequency Domain Imaging (OFDI)
Optical Coherence Tomography
Imaging
Celiac Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 108
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.

A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.

Detailed description: Subjects including healthy volunteers as well as patients with Celiac disease will be recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus, through the stomach and into the duodenum using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are acquired. Images are analyzed at a later stage.

Eligibility criteria: Inclusion Criteria:

* Subject must be over 18 years for healthy volunteers
* Subjects must be over 16 years for patients with Celiac disease
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with an inability to swallow pills or capsules.
* Subjects with esophageal or intestinal fistulas.
* Subjects with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
* Subjects with a history of intestinal Crohn's disease.
* Women who are pregnant.

Primary outcomes:
measure: Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
timeFrame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
measure: Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
timeFrame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: