louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02298452: Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids
Official title: Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Bilateral or Unilateral
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 253
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

Brief summary: The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

Detailed description: This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Eligibility criteria: Inclusion Criteria:

* all kinds of hearing loss (sensorineural, conductive, combined)
* all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
* mother tongue (swiss) german

Exclusion Criteria:

Subjects

* with a reduced mobility unable to attend weekly study appointments
* without access to a number of different hearing situations
* with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
* which are uncooperative so that it is not possible to record a valid pure tone audiogram
* with a strongly reduced dexterity
* with psychological problems
* central hearing disorders

Primary outcomes:
measure: Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles
timeFrame: 3 years
Secondary outcomes:
measure: Subjective ratings of speech intelligibility during home trials
timeFrame: 3 years
measure: Subjective ratings of sound quality during home trials
timeFrame: 3 years
measure: Subjective ratings of usability during home trials
timeFrame: 3 years
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Phonak AG
state: Zürich
Study officials:
affiliation: Phonak AG
name: Simone Ebbing, B. Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04175652: Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality
Official title: Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Yoga
Hemodialysis Patients
Keywords: Laughter Yoga
Hemodialysis
Pain
Sleep
Beta Endorphin
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.

Detailed description: While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* receiving treatment in a dialysis center
* must be between 18 and 80 years old and willing to participate in the study
* receiving HD treatment at least twice a week for a month or longer
* having a pain level and above
* level of 5 above according to the Pittsburgh Sleep Quality Index.

Exclusion Criteria:

* not taking any medicine for sleeping disorder
* not having any visual, hearing or communication impairments
* not having any mental disorders

Primary outcomes:
measure: Beta-endorphin Level
timeFrame: 8 week
measure: Visual Analog Scale
timeFrame: 8 week
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
state: Küçükçekmece
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz Ozer, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heo EH, Kim S, Park HJ, Kil SY. The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016 Nov;25:1-7. doi: 10.1016/j.ctcp.2016.07.001. Epub 2016 Jul 27.
citation: Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243.
Clinical trial NCT01497652: A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy
Official title: A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Cognition
Rasagiline
MoCA
Mild Cognitive Impairment in Parkinson's Disease
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Teva Neuroscience, Inc.
First posted: 2011-12-22
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present pilot study is designed to assess the extent to which rasagiline may improve cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to assess changes in the SCOPA-COG, FAB, and UPDRS II \& III at the end of week 14.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 40 or older with idiopathic Parkinson's disease on stable dopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used to establish the diagnosis of Parkinson's disease. Women must be post menopausal or agree to avoid pregnancy. Modified Hoehn \& Yahr staging \< 3 and MoCA score must be greater than 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and specific screen for depression in the Parkinson's disease population. GDS scores of \< 5 will be included in the study.

Exclusion Criteria:

* Patients with secondary dementia, severe depression and atypical Parkinson's syndromes or Parkinson's plus will be excluded from the study. Patients on acetylcholine esterase or NMDA inhibitor medication will be excluded from the study. Patients with history of brain surgery for Parkinson's disease, stroke or significant head injury, active epilepsy will be excluded. Patients on Amantidine, neuroleptics, metoclopramide, alphamethyldopa within the last 6 months will be excluded. Individuals using meperidine, and tramadol will be excluded. Patients with congestive heart failure or myocardial infarction will also be excluded to avoid vascular dementia.

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 14 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Fernando L Pagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04997252: An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Official title: An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-Risk and Oligometastatic Prostate Cancer
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.


Eligibility criteria: Inclusion Criteria:

1. Adult males aged above 18 years old, no healthy volunteers included;
2. Prostate cancer confirmed by pathological findings;
3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
5. ECOG score of 0 - 1
6. Agreement to undergo preoperative and postoperative endocrine therapy;
7. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria:

1. Any other tumor disease requiring treatment;
2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
3. A history of epilepsy or any condition that may lead to seizures;
4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.

Primary outcomes:
measure: rPFS
timeFrame: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Secondary outcomes:
measure: pCR
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
measure: PFS
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
measure: PSA response rate:
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
measure: TTPP
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
measure: time to BCR after surgery
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
measure: pathological stage
timeFrame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT06233552: Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading
Official title: Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Edentulism
Keywords: immediate loading
denture conversion
full arch implant rehabilitation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture.

Detailed description: After intra oral scanning of the ridge form, implant positions, the denture is used to scan the intermaxillary relation and tooth positions and the fixed interim is designed and milled from PMMA. This technique is applicable when a single arch is treated or for bimaxillary implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I in which a converted denture was made conventionally and Group II in which a converted denture was made digitally. General satisfaction, chair side working time, and esthetic outcome of the prostheses were recorded and quantified with a verbal rating scale following insertion of implant-supported prosthesis.

Eligibility criteria: Inclusion Criteria:

* -Nonsmokers
* Free from any systemic disease
* Non-bruxers
* With sufficient quality and quantity of bone
* Prepared to comply with the follow-up and maintenance program

Exclusion Criteria:

* - Patients with bad oral hygiene.
* Patients with limited mouth opening.
* Vulnerable groups.
* Uncooperative patients.

Primary outcomes:
measure: Patient general satisfaction questionnaire
timeFrame: through study completion within 6 months
Secondary outcomes:
measure: chair side working time questionnaire
timeFrame: through study completion within 6 months
measure: esthetic satisfaction questionnaire
timeFrame: through study completion within 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT03736252: Effectiveness of a Neoprene CMC Joint Orthosis
Official title: Effectiveness of a Neoprene CMC Joint Orthosis for Pain, Function, and Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMC
Keywords: Orthosis
Pain
Function
Lead sponsor: Gannon University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 75
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 with painful CMC OA

Brief summary: Patients will be gathered via convenience sample from a hand therapy clinic. They will be provided with a neoprene commercially available orthosis free of charge. Baseline pain and function will be assessed using the VAS and Functional Index of Hand Arthropathies. Four weeks later, pain, function, and patient satisfaction with the device will be gathered using the Quebec User Evaluation of Assistive Technology questionnaire.

Detailed description: Patients with the diagnosis of carpometacarpal osteoarthritis that are receiving hand therapy will be recruited for the study. Baseline measurements will include usual pain over the past week, current pain, and worst pain experienced over the past week using the VAS pain scale. Hand function will be assessed using the Functional Index of Hand Arthropathies measure. The patients will be provided with a free neoprene hand orthosis (Hely and Weber CMC controller). They will be instructed to wear the device as needed for pain. After 1 month, the investigators will call the patient to assess pain, function, and satisfaction with the device using the Quebec User Evaluation of Assistive Technology Questionnaire.

Eligibility criteria: Inclusion Criteria:

* CMC OA of either thumb with pain

Exclusion Criteria:

* CMC arthroplasty
* recent surgery
* dementia
* no pain at CMC joint

Primary outcomes:
measure: Pain using the Visual Analog Scale (VAS) scale
timeFrame: 1 month
Secondary outcomes:
measure: Hand osteoarthritis Function
timeFrame: 1 month
measure: Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: 1 month
Other outcomes:
Locations:
city: Ruskin
country: United States
facility: Gannon University
state: Florida
Study officials:
References:
Clinical trial NCT06536452: Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects
Official title: Hematopoiesis in Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) Versus Healthy Age-Matched Control Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Monoclonal B-Cell Lymphocytosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MBL, patients with CLL ,and healthy subjects recruited through Mayo Clinic.

Brief summary: This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the cellular and mechanistic basis of bone marrow (BM) hematopoietic dysfunction in untreated MBL and CLL patients.

II. Determine if MBL and CLL B cell derived cellular products directly alter the differentiation and functional capacities of Hematopoietic Stem and Progenitor Cells (HSPCs).

III. Utilize the Emu-Tcl1 transgenic mouse model to determine how MBL and CLL patient-derived cellular products alter BM hematopoiesis.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Subjects in the CLL cohort who are eligible for these studies will have a clinically established diagnosis of CLL as assessed by flow cytometry and will include subjects who

  * Remain untreated
  * Are currently being treated
  * Who have already been treated
* Subjects in the MBL cohort will have a clinically established diagnosis of MBL
* Healthy age-matched control subjects
* Healthy younger control subjects aged \> 40 years

Exclusion Criteria:

* Anyone under 40
* Healthy control subjects must not have a diagnosis of CLL or MBL

Primary outcomes:
measure: Effects of MBL on bone marrow function
timeFrame: Baseline
measure: Effects of CLL on bone marrow function
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Neil E. Kay, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147652: Personalized Music Therapy and Agitation in Dementia
Official title: Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Vascular Dementia
Keywords: moderate dementia
severe dementia
Alzheimer's disease
Vascular dementia
agitation
personalized music therapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).

This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
* moderate stage of dementia, a score of \<20 on MMSE;
* Age 60 to 90 inclusive;
* Preserved hearing (hearing aids are permissible);
* Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.

Exclusion Criteria:

* auditory deficits requiring correction beyond hearing aids.
* no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
* recent acute event eg. MI, fractures, or major infection (not UTI)
* patients receiving standing orders of medication for personal care

Primary outcomes:
measure: Changes in agitation
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease
name: Carmela Tartaglia, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198652: Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
Official title: Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Postpartum Uterine Bleeding
Lead sponsor: Glenveigh Medical
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received treatment with the BD-OTS as part of their standard of care in hospital.

Brief summary: This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.


Eligibility criteria: Inclusion Criteria:

* Treatment with the BD-OTS device

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Denver
country: United States
facility: Presbyterian/St. Luke's Medical Center
state: Colorado
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Johnson City
country: United States
facility: UHS - Wilson Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger
state: Tennessee
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Austin
country: United States
facility: North Austin Medical Center - St. David's Women's Center of Texas
state: Texas
Study officials:
affiliation: Glenveigh Medical
name: David Adair, MD
role: STUDY_DIRECTOR
References: