louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02379273: Nucleus Hybrid L24 Extended Duration Post Approval Study
Official title: The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: NYU Langone Health
name: Midwest Ear Institute
name: University of Cincinnati
name: The Center for Hearing and Balance Disorders
name: Ohio State University
name: Mayo Clinic
name: Hearts for Hearing
First posted: 2015-03-04
Enrollment: 35
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: This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Detailed description: The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed.

Eligibility criteria: Inclusion Criteria:

- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Exclusion Criteria:

* Recipients who withdrew or were terminated from the L24 pivotal IDE study
* Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

Primary outcomes:
measure: Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
timeFrame: 5 years postactivation.
measure: AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
timeFrame: 5 years postactivation.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Bruce J Gantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.
Clinical trial NCT01605773: Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes
Official title: Repaglinide Versus Glyburide: Comparitive Effect on Postprandial Lipemia: An Open-labeled, Randomized, Parallel Group Study in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 51
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 trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
* Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
* Males or non-pregnant, non-lactating females
* Subjects should have normal renal function

Exclusion Criteria:

* Type 1 or other specific causes of diabetes
* Marked symptomatic diabetes
* Uncontrolled treated/untreated hypertension
* Known or suspected allergy to the trial products or related products

Primary outcomes:
measure: Triglyceride levels post standardised fat tolerance test
Secondary outcomes:
measure: Incidence of hypoglycemic episodes
measure: Change in HbA1c (glycosylated haemoglobin A1c)
measure: Change in FPG (fasting plasma glucose)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00578773: A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Official title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
Keywords: ear tubes
ear infection
ear drops
ear tube surgery
acute otitis media
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 303
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.


Eligibility criteria: Inclusion Criteria:

* 6 months to 12 years old
* Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
* Must be first set of ear tubes.
* Patient may not have had any other previous otologic-related surgery.
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have existing perforation of the eardrum.
* Patient must not require another surgical procedure other than myringotomy and tube insertion.
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study.
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
timeFrame: From baseline
Secondary outcomes:
measure: Clinical cures at each visit
timeFrame: From baseline
measure: Absence of otorrhea at each visit
timeFrame: From baseline
Other outcomes:
Locations:
Study officials:
affiliation: 1-888-451-3937
name: Contact Alcon Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02852473: Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
Official title: Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: Continuous Positive Airway Pressure
Radiotherapy
Proton Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 10
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: This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.

The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.

Detailed description: Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).

Eligibility criteria: Inclusion Criteria:

1. Healthy adult female and males
2. Subject meets routine MRI safety criteria

Exclusion Criteria:

1. Age \<18
2. Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
3. Pregnancy
4. Any safety risk identified via MRI safety screening

Primary outcomes:
measure: Change in Breathing Motion Characteristics at High CPAP Setting
timeFrame: Data acquisition for this portion of the study will require approximately 30 minutes.
Secondary outcomes:
measure: Change in Breathing Motion Characteristics at Lower CPAP Setting
timeFrame: Approximately 45 minutes into visit.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erik J Tryggestad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298973: Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Official title: Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent, complete questionnaires, and likely to complete all visits
* Subject must be male or female, of any race, and at least 21 years old
* Undergoing uncomplicated cataract surgery with clear corneal incisions

Exclusion Criteria:

* Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
* Uncontrolled systemic disease
* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
* Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
* Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
* Concurrent participation or participation in the last 30 days in any other clinical trial

Primary outcomes:
measure: Ensure watertight, patient wound closure after clear corneal cataract incisions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Maitland
country: United States
facility: Eye Physicians of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT00153673: Effect of Selective COX-2 Inhibition on Ulcer Healing
Official title: Phase III Study of a Double-Blind Randomized Comparison of Famotidine Plus Celecoxib Versus Dologesics for Gastric Ulcer Healing in Arthritis Patients (NSAID#5A Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Gastric Ulcer
Keywords: celecoxib
arthritis
ulcer healing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
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: The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.

Detailed description: For many years the integrity of the stomach mucosal barrier is thought to be maintained by mucosal prostaglandins (PG) synthesized by COX-1. However, the notion that COX-1 protects the stomach and COX-2 induces inflammation may be over-simplistic. In animal studies, COX-2, but not COX-1, is expressed in experimental gastric ulcer. Inhibition of COX-2 delays ulcer healing, indicating that PG derived from COX-2 contributes to restoring the mucosal barrier \[1\]. Whether this animal observation can be generalized to the human stomach is unknown. To date the biological functions of COX-1 and COX-2 in the healing of human gastric ulcer healing is unclear. Unlike experimental ulcers that only express COX-2, recently we have shown that both COX-1 and COX-2 are up-regulated in human gastric ulcers \[2\]. Furthermore, our preliminary results suggest that inhibition of COX-2 alone may not lead to a clinically significant delay in ulcer healing (refer to progress report). These observations suggest that peptic ulcer healing is more complex in the human stomach - both COX isoforms may be involved in the healing process. Inhibition of COX-2 alone may have less adverse effect than non-selective inhibition of both COX isoforms in ulcer healing. The current study aims to resolve the functional significance of COX-2 in human gastric ulcer from a biological and clinical perspective.

Eligibility criteria: Inclusion Criteria:

* Gastric ulcers confirmed by endoscopy
* Stop taking NSAIDs for 1 week prior to endoscopy
* Age 18
* H. pylori negative
* Informed written consent

Exclusion Criteria:

* Actively bleeding ulcers
* Ulcers showing dysplasia or malignancy
* Renal failure (serum creatinine \>200umol/l)
* Previous gastric surgery
* Moribund or terminal malignancy
* Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant

Primary outcomes:
measure: ulcer healing
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Francis K Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04313673: Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening
Official title: Can the Measurement of Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening Between Weeks 18-22 ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: ultrasonography
transvaginal
transabdominal
second trimester
preterm labor
predict
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 randomized

Brief summary: Sonographically, cervical length measurement is widely used in obstetrics. Studies have revealed that early detection of short cervix can be a predictor of predicting preterm labor. Transvaginal ultrasonography has been shown as a reference method for the recognition of the short cervix, as well as it may be useful in the transabdominal evaluation in the studies conducted. In addition to the advantages of transvaginal evaluation, it is time consuming and disadvantages of some women during anxiety and discomfort during this procedure. Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal. The aim of this study is to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

Detailed description: Births that occur before 37th gestational week are an important cause of perinatal morbidity and mortality. Preterm birth accounts for about 12% of all births. Early screening and correct management of pregnant women at risk of preterm birth is essential in reducing perinatal mortality and morbidity associated with prematurity. But the precise prediction and prevention of preterm birth is still an important research topic.

Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal.The aim of this study was to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

Eligibility criteria: Inclusion Criteria:

-Pregnant women who gave birth in our clinic and have a 2nd trimester cervical length measurement

Exclusion Criteria:

* uterin anomaly
* multiple pregnancy cases with a history of cervical surgery
* termination of pregnancy due to fetal or maternal reasons

Primary outcomes:
measure: preterm labor
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical Universty Medical School
Study officials:
affiliation: karadeniz thecnical universty
name: suleyman guven, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06675773: The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers
Official title: The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers on Conscious Awareness, Job Stress and Compassion Fatigue.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: Mindfulness,
Work stress
Compassion Fatigue
Psychoeducation
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were mindfulness-based psychoeducation controls.
Primary purpose: PREVENTION

Brief summary: This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue.

Detailed description: This study was planned in an experimental design with pre-test post-test follow-up measurements, experimental and control groups. The universe of the study consisted of care personnel working in institutions affiliated to the Provincial Directorate of Family, Labor and Social Services located in a city center in the east of Turkey. The sample calculation was made using the G-Power program (Experiment 14, Control 14). Since there may be omissions, the experimental group was determined as 20 participants and the control group as 20 participants. In this study, a nine-session training program will be applied to the experimental group. No application will be made to the control group. The conscious awareness development psychoeducation program will be applied once a week and for 90 minutes. Each session will be conducted in line with certain objectives. The sessions will be conducted by the investigator. Ethics committee approval was obtained before starting the study. Institutional permissions and written informed consent will be obtained for the participants. Informed consent will include information about the research and information that will ensure confidentiality.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age,
* Being actively working as a care worker in relevant institutions.

Exclusion Criteria:

* Having received similar training before
* Having been diagnosed with a mental illness
* Wanting to leave the study at any stage.
* Not having attended more than two sessions.

Primary outcomes:
measure: The Mindful Attention Awareness Scale-MAAS
timeFrame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Secondary outcomes:
measure: General Work Stress Scale
timeFrame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
measure: Compassion Fatigue Scale- Short Scale Form
timeFrame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Faculty of Health Sciences Kafkas University
state: Merkez
Study officials:
affiliation: Lecturer
name: Nilüfer KIRANŞAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741973: Yoga in School Sports - a Pilot Study in Germany
Official title: Yoga in School Sports - a Non-randomized Controlled Pilot Study in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Stress
Keywords: Yoga
Stress
Adolescents
School
Children
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 102
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for school sports to evaluate potential effects in stress reduction and concomitant psychological parameters.


Eligibility criteria: Inclusion Criteria:

* Students of Berlin Oberstufenzentrum (OSZ) aged 17-27 years
* Written consent (with parents at underage (17 years)

Exclusion Criteria:

* Severe chronic or acute diseases
* Pregnancy or lactation
* Immobility or restriction for gymnastic exercises because of orthopedic, neurological or other medical reasons
* Participation in another study

Primary outcomes:
measure: Cohen Perceived Stress Scale (CPS)
timeFrame: Change in CPS from Baseline to 10 weeks
Secondary outcomes:
measure: Cohen Perceived Stress Scale (CPS)
timeFrame: Change in CPS from Baseline to 6 months
measure: WHO-5 questionaire (quality of life)
timeFrame: Baseline, 10 weeks, 6 months
measure: Hospital Anxiety and Depression (HADS)
timeFrame: Baseline, 10 weeks, 6 months
measure: Profile of Mood States (POMS)
timeFrame: Baseline, 10 weeks, 6 months
measure: Visual analogue scales (VAS) for general pain, headache, shoulder and neck tension, fatigue, sleep quality
timeFrame: Baseline, 10 weeks, 6 months
measure: D2 Test of Attention
timeFrame: Baseline, 10 weeks, 6 months
measure: Yoga Self-Efficacy Scale
timeFrame: Baseline, 10 weeks, 6 months
measure: Overall assessment of efficacy and tolerability (Likert scales)
timeFrame: Baseline, 10 weeks, 6 months
Other outcomes:
measure: Heart rate variability
timeFrame: Baseline, 10 weeks, 6 months
measure: Qualitative interviews in focus groups
timeFrame: 5 weeks, 10 weeks
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References: