louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04840277: Remote Hearing Aid Adjustment for Experienced Hearing Aid Users
Official title: Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Aids
Lead sponsor: Sodra Alvsborgs Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.

The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.


Eligibility criteria: Inclusion Criteria:

* \>18 yr of age
* experienced hearing aid user

Exclusion Criteria:

* \<18 yr of age
* new hearing aid users

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)
timeFrame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
Secondary outcomes:
measure: The Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Hearing Clinic, Hearing Organization
state: Vastra Gotalandsregion
Study officials:
affiliation: Hearing Organization, Sweden
name: Milijana Malmberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00190177: ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 370
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE

Brief summary: The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

Detailed description: It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included.

The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls).

The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels.

CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.

Eligibility criteria: Inclusion Criteria:

* cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study

Exclusion Criteria:

* Cases:

multiple pregnancy, proteinuria \> 300 mg/24h before 21th gestation week.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Mandelbrot, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206877: Topical Insulin for Glaucoma
Official title: Topical Insulin for Glaucoma and Optic Neuropathies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Glaucoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).


Eligibility criteria: Inclusion Criteria:

* Capable to provide informed consent
* Diagnosis of optic neuropathy either glaucoma or NAION or optic disc drusen.
* Only one eye per patient will be selected as the study eye - if both eyes meet the inclusion criteria, the eye with the worse acuity and /or visual field will be selected. The contralateral eye will be left untouched.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Presence of any ocular pathologies other than glaucoma that contributes to the severe vision loss (retinopathy / maculopathy, severe uveitis, keratopathy, etc.)
* Diagnosis of glucose intolerance, type 1 or 2 diabetes mellitus
* Inability to perform reliable visual field
* Unable to provide informed consent
* Unable to complete the tests and follow-ups required by the study

Primary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: During treatment period, difference from baseline to post-treatment up to 2 months
Secondary outcomes:
measure: Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)
timeFrame: During treatment period, difference from baseline to post-treatment up to 2 months
measure: The change in visual field as measured by mean deviation
timeFrame: During treatment period, difference from baseline to post-treatment up to 2 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jeffrey L Goldberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386877: Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)
Official title: Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.

Detailed description: In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* diagnosis of advanced chronic periodontitis
* FMPS\<20%
* FMBS\<20%
* infrabony defect \>2mm
* Probing depth \>5mm
* presence of 1 vital and intact tooth requiring an extraction as autologous source of DPSCs

Exclusion Criteria:

* smoking
* controindicazion for periodontal surgery
* systemic diseases affecting periodontal healing
* pregnancy an lactation
* fixed orthodontic appliance
* history of periodontal surgery at the experimental teeth
* prostethic restorations at the experimental teeth
* furcation defects

Primary outcomes:
measure: Radiographic bone fill
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Probing depth reduction
timeFrame: baseline, 6 and 12 months
measure: Clinical attachment gain
timeFrame: baseline, 6 and 12 months
measure: Recession reduction
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: CIR dental school
state: Piedmont
city: Turin
country: Italy
facility: CIR Dental school Turin University
state: Piedmont
Study officials:
affiliation: Turin University
name: Mario Aimetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247153: Influence of Corticosteroids on Heart Function
Official title: Influence of Corticosteroid Therapy on Heart Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart; Complications
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-08-11
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: BASIC_SCIENCE

Brief summary: This study will examine the effect of corticosteroid treatment on heart function.


Eligibility criteria: Inclusion Criteria:

* Patients with good echogenic body structure
* Patients with sinus rhythm with no conduction disorder

Exclusion Criteria:

* Patients with major medical condition
* Patients who are not hemodynamical stable
* Patients receiving long-term corticosteroid therapy

Primary outcomes:
measure: Changes in heart function
timeFrame: One month after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Nina Avshovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724653: Tapering Heart Failure Medication in Patients with Heart Failure with Recovered Ejection Fraction; Open Label Prospective Random Trial
Official title: Tapering Heart Failure Medication in Patients with Heart Failure with Recovered Ejection Fraction; Open Label Prospective Random Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Ejection Fraction
Recovery of Function
Keywords: heart failure with recovered ejection fraction
Tapering
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomly assignment to 3 groups ( drug tapering_RAS blocker, beta blocker, drug maintaining)
Primary purpose: TREATMENT

Brief summary: Study start date is on Nov 27th 2024.

A patient with an initial ejection fraction (EF) of less than 40%, whose follow-up shows an improvement to an EF of 50% or higher, along with the left ventricular end-diastolic diameter returning to the normal range and taking 3 more heart failure medication randomed to drug tapering group ( RAS blocker or beta blocker) or continuing medication group.

Detailed description: Patients described above randomly assigned to drug tapering group and drug maintaining group.

Drug tapering group is 2 groups, which one is RAS blocker tapering group and others is beta blocker tapering group.

Drug tapering group is monitored ejection fraction, LV dimension and LV GLS by 1-3 month.

Eligibility criteria: Inclusion Criteria:

* initial echocardiogram ejection fraction less than 40%
* follow up echocardiogram ejection fraction over 50% and LVEDD index normal range
* NTprobnp criteria

  1. eGFR ≥60 ; less 440
  2. eGFR 45-59: less 980
  3. eGFR 30-44; less 1220
  4. eGFR \< 30 : less 5300
  5. in HD; no criteria for NTproBNP
* on more than 3 heart failure medication ( RAS blocker, beta blocker, mineral corticoid receptor antagonist, SGLT 2 inhibitor)

Exclusion Criteria:

1. under age 18 year
2. uncontrolled BP ( over 150/90)
3. coronary revascularization within 6 months
4. significant valve disease
5. arrhythmia requiring rate control
6. CKD with albuminuria ( over 30mg/g)
7. Pregnancy

Primary outcomes:
measure: Heart failure relapse
timeFrame: From enrollment to the end of treatment at 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00154453: Age-Related Changes in Myosin Heavy Chain Composition in Human Orbicularis Oculi Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Keywords: Aging
Orbicularis oculi
Blepharoplasty
Myosin heavy chain (MHC)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. We believe that understanding the age-related histomorphometric changes in orbicularis oculi muscle is important for improving the current rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this topic has never been performed before, simply because it is difficult and dangerous to perform needle biopsy on orbicularis oculi muscle.

Detailed description: Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral orbicularis oculi muscle can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and determines the maximum contraction speed of the muscle fiber. Therefore, The composition of MHC isoforms represents the composition of different types of muscle fiber.

These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After electrophoresis and staining, bands of different types of MHC can be visualized. The gel is scanned and processed with an image analysis system. The density of each band can be determined, and the ratio of the different types of MHC can be calculated.

By dividing the subjects who had their orbicularis oculi muscle sampled during upper blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC subtypes composition ratios can be compared among the different groups. Therefore, the age-related changes of the composition of different muscle types can be concluded.

Eligibility criteria: Inclusion Criteria:

* patients receiving blepharoplasty

Exclusion Criteria:

-

Primary outcomes:
measure: Differentiation capability of preadipocyte
Secondary outcomes:
measure: Proliferation capability of preadipocyte
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yueh-Bih Tang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01525953: Complete Clinical Responders to Definite Chemoradiation in Esophageal Cancer : a Survival Analysis
Official title: Predictors of Survival for Complete Clinical Responders to Definite Chemoradiation or Radiation Therapy for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: esophageal cancer
radiochemotherapy
prognosis
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 110
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: Patient treated for esophageal cancer in the Northern France Cancer Center from january 1998 to december 2003

Brief summary: The aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer


Eligibility criteria: Inclusion Criteria:

* localized or locally advanced esophageal cancer
* patient who underwent definite chemoradiation or radiation
* patient with complete clinical response

Exclusion Criteria:

* metastatic disease

Primary outcomes:
measure: Identification of prognostic factors for overall survival
timeFrame: From date of treatment until death, assessed up to 10 years
Secondary outcomes:
measure: Patterns of treatment failure
timeFrame: From date of treatment until treatment failure, assessed up to 10 years
measure: Disease-free survival
timeFrame: From date of treatment until progression or death, assessed up to 10 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar LAMBRET
Study officials:
affiliation: Centre Oscar Lambret
name: Antoine ADENIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06499753: Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
Official title: Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Hyaluronic Acid
OSDI
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 1033
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health volunteers

Brief summary: This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education

Detailed description: This was a multicentre study enrolling patients to attend primary eye care centres of the EMO research group across 12 different Spanish locations. A comprehensive eye examination was performed in all participants. Dryness symptomatology was assessed with OSDI questionnaire. In subjects with dryness symptomatology (OSDI questionnaire score between 13 and 32) were prescribed to use high molecular weight HA-based artificial tears (DISOP Inc, Spain) along three months), instilled 3 times per day.

Additionally, the daily mean, minimum, and maximum values of the climate data for five different variables \[skin temperature (°C), wind gusts (m/s), air temperature (°C), atmospheric pressure (Pa) and RH (%)\] corresponding to the visit date were collected from the EU-funded Copernicus Climate Change Service and the 5-year average RH values published by the Spanish meteorological agency.

Eligibility criteria: Inclusion Criteria:

• Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center

Exclusion Criteria:

* Hyperthyroidis
* Rheumatism
* Lupus
* Autoimmune disease
* Previous diagnosis of Dye Eye Disease
* Cicatricial conjunctivitis
* Pterygium
* Eyelid trichiasis
* History of any eye medication use in the last 3 months to treat any eye condition (glaucoma, etc.)
* Active anterior eye inflammation (such as blepharitis, conjunctivitis, keratitis, scleritis, uveitis, etc.)
* Use of contact lenses in the last 3 months
* Previous ocular trauma or surgery in the last 6 months.

Primary outcomes:
measure: OSDI Score
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: IOBA Eye Institute
Study officials:
affiliation: IOBA Eye Institute
name: Raul Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921253: Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy
Official title: Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lymphoma
Keywords: Stimulation Device
Vagus Nerve Stimulator
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 104
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.
Primary purpose: OTHER

Brief summary: This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.

Detailed description: Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.

Eligibility criteria: Inclusion Criteria:

* Patients (\>50 years) who have received anthracycline-based therapy (a cumulative dose of ≥ 200 mg/m2 Doxorubicin or bioequivalent dose of other anthracyclines) for breast cancer or lymphoma within the last 15-30 days
* A least 1 of following additional criteria:

  * previous chest radiation
  * type 2 diabetes mellitus
  * hypertension
  * current smoking
  * obesity (BMI ≥ 30)
  * previous myocardial infarction
  * established atherosclerotic heart disease.

Exclusion Criteria:

* Atrial paced rhythm
* History of seizure currently on treatment
* History of vasovagal syncope
* End stage liver or kidney disease

Primary outcomes:
measure: Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Effects of LLTS on autonomic tone
timeFrame: 2 weeks
measure: Effects of LLTS on oxidative stress
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Tulsa
country: United States
facility: Stephenson Cancer Center- Tulsa
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Tarun W. Dasari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: