louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02555462: Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Validation Studies
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 205
Sex: ALL
Minimum age (years): 16
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.


Eligibility criteria: Inclusion Criteria:

* Clean and healthy ear canal, eardrum and pinna
* Ability to keep current position (of head and body) during a period of about 5 minutes while seated.

Exclusion Criteria:

* Ear infections
* Ear wax in the ear
* Hyperacusis
* Pacemaker
* Tremor
* Disability to keep position.

Primary outcomes:
measure: Distance (mm) from probe tube to eardrum measurement
timeFrame: 1 month
measure: Procedure time (min) of fitting workflow including Real Ear measurement
timeFrame: 2 month
Secondary outcomes:
measure: Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)
timeFrame: 1 month
measure: Questionnaire about perceived annoyance
timeFrame: 2 month
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Phonak AG
state: Zürich
Study officials:
References:
Clinical trial NCT00145262: TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation
Official title: Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Buerger Disease
Arteriosclerosis Obliterans
Keywords: critical limb ischemia
bone marrow mononuclear cells
angiogenesis
vasculogenesis
Arteriosclerosis Obliterans (ASO)
Ischemic ulcers
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2005-09-05
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).


Eligibility criteria: Inclusion Criteria:

* Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation.

Exclusion Criteria:

* Poorly controlled diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 6.5% and proliferative retinopathy)
* Evidence of malignant disorder during the past 5 years
* Subjects who cannot survive more than 1 year with other complications
* Malignant rheumatic arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Cardiology, Nagoya University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiology, Nagoya University Graduate School of Medicine
name: Toyoaki Murohara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
citation: Kajiguchi M, Kondo T, Izawa H, Kobayashi M, Yamamoto K, Shintani S, Numaguchi Y, Naoe T, Takamatsu J, Komori K, Murohara T. Safety and efficacy of autologous progenitor cell transplantation for therapeutic angiogenesis in patients with critical limb ischemia. Circ J. 2007 Feb;71(2):196-201. doi: 10.1253/circj.71.196.
Clinical trial NCT04012762: Vibration Training and Muscles Properties
Official title: The Acute Responses of Muscles Properties to the Different Whole Body Vibration Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Relaxation
Keywords: Muscle Power, Muscle Flexibility, Muscle Tone, Whole-Body Vibration Training.
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Application dose standards have not yet been determined for Whole Body Vibration Training which is subject to studies with different frequencies and amplitudes. Our objective was to examine acute responses of two different vibration training doses on muscle tone, strength, and flexibility.

Detailed description: Application dose standards have not yet been determined for Whole Body Vibration Training which is subject to studies with different frequencies and amplitudes. Our objective was to examine acute responses of two different vibration training doses on muscle tone, strength, and flexibility.

Eligibility criteria: Inclusion Criteria:

* Healthy and untrained participants.
* Dominant side of the participants was recorded and only right dominant individuals were included.

Exclusion Criteria:

* Participants with body weight over 120 kg.
* Participants had lower extremity trauma and lower extremity movement restriction.
* Participants who had any cardiovascular or neurological conditions, dizziness or vertigo

Primary outcomes:
measure: Muscle Tone
timeFrame: 30 minute
measure: Muscle power
timeFrame: 30 minute
measure: Flexibility
timeFrame: 30 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Okan University
state: İ̇stanbul
Study officials:
affiliation: Okan University
name: Emine Atıcı, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021562: A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
Official title: Zedula Special Drug Use Observational Study "Ovarian Cancer"
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 354
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An individual who corresponds to any of the following: ovarian cancer patients after initial chemotherapy (maintenance therapy), patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy), or recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

Brief summary: The main aim of this study is to check for side effects from treatment with niraparib.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.


Eligibility criteria: Inclusion Criteria:

An individual who corresponds to any of the following:

* Ovarian cancer patients after initial chemotherapy (maintenance therapy)
* Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy)
* Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

Exclusion Criteria:

Has a history of hypersensitivity to any of the ingredients of this drug.

Primary outcomes:
measure: Number of Participants with Adverse Event of Myelosuppression
timeFrame: 1 year
measure: Number of Participants with Adverse Event of Hypertension
timeFrame: 1 year
measure: Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome
timeFrame: 1 year
measure: Number of Participants with Adverse Event of Interstitial Lung Disease
timeFrame: 1 year
measure: Number of Participants with Adverse Event of Secondary Malignant Tumors
timeFrame: 1 year
measure: Number of Participants with Adverse Event of Thromboembolism
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Participants Who Achieve or Maintain Any Best Overall Response Category in Population of Recurrent Ovarian Cancer Participants with Platinum-Sensitive Homologous Recombination Repair Defects
timeFrame: 1 year
measure: Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study
timeFrame: 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02500862: Characterization of Potential Biomarkers of Eye Disease and Vision
Official title: Characterization of Potential Biomarkers of Eye Disease and Vision Loss.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Eye Disease
Keywords: Eye
Imaging
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient followed under the normal clinical practice at AIBILI Clinical Trial Centre, and with a AIBILI signed informed consent form for data collection, Imp. 11-7-2 "Consentimento Informado para tratamento de dados".

Brief summary: Characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at CEC, AIBILI

Detailed description: This is a registry study. Only patients followed under the clinical practice at AIBILI Clinical Trial Centre, and with a signed informed consent form will be included.

Based on the clinical information collected under the clinical practice, and based on patients' characteristics, scientific questions will be raised and data will be collected and analysed accordingly.

Any procedure performed under clinical practice that may allow for the characterization of the disease and/or for the identification of potential biomarkers will be collected and analysed.

Eligibility criteria: Inclusion Criteria:

* Any patient followed under the normal clinical practice at AIBILI Clinical Trial Centre, and with a AIBILI signed informed consent form for data collection, Imp. 11-7-2 "Consentimento Informado para tratamento de dados".

Exclusion criteria:

* None

Primary outcomes:
measure: Characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at CEC, AIBILI.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: CEC
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Maria L Ribeiro, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02039362: Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
Official title: Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
HBV
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

Detailed description: The prevalence of HBs Ag carriage in pregnant women varies in France, according to the native country, with higher rates in those originating from sub-Saharan Africa and Asia (5 to 8% in Parisian area). The level of HBV DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). The rate of vertical transmission (Yuan J et al. J Viral Hepatitis 2006) was 0% in newborns to mothers with HBV DNA less than 100,000 copies/mL and up to more than 40% in newborns to mothers with HBV DNA above 8 Log10 copies/mL, despite serovaccination at birth, thus justifying the use of tenofovir DF during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in EASL 2012 Guidelines. Data are needed concerning the results of this strategy in western countries, justifying this prospective study.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* positive for HBs Ag
* HBV DNA above 100,000 I.U/mL

Exclusion Criteria:

* HIV co-infection
* HDV co-infection
* requiring, according to the physician's decision, a treatment for herself and not only to prevent HBV MTC transmission

Primary outcomes:
measure: Rate of chronically infected (positive HBs Ag) children born from mothers with HBV DNA above 100, 000 I.U/mL being given tenofovir during the last trimester of pregnancy.
timeFrame: At 9 months after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere, Paris, France
name: Pierre O SELLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sellier PO, Maylin S, Bercot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Benifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.
Clinical trial NCT01833962: A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
Official title: A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Fusion
Keywords: Lumbar fusion rates
Actifuse synthetic bone graft
Baxter Healthcare
Other synthetic bone graft
Lead sponsor: OrthoGeorgia
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study patients will be extracted from our current patient population. A total of 50 patients treated with Actifuse and 50 patients treated with other synthetic bone grafting substitutes

Brief summary: The purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.


Eligibility criteria: Inclusion Criteria:

* Any patient 18 years of age or older
* Patients with a minimum follow up of 1 year
* Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures

Exclusion Criteria:

* Patients under the age of 18
* Any patient with less than 1 year of follow up history at the time of first data analysis
* Any patient that the primary investigator deems as an unfit candidate

Primary outcomes:
measure: Achievement of fusion prior to or at 12 months postoperatively
timeFrame: 6 - 12 months year
Secondary outcomes:
Other outcomes:
Locations:
city: Macon
country: United States
facility: OrthoGeorgia
state: Georgia
Study officials:
affiliation: Physician
name: William B Dasher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825862: Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor
Official title: Circumventing the 'Ick' Factor: a Multi-site Randomised Trial of the Effects of Omitting Affective Attitudes to Increase Intention to Become an Organ Donor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donation
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: Manipal University
First posted: 2016-07-07
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University).


Eligibility criteria: Inclusion Criteria:

* Agree to participate

Exclusion Criteria:

* Refuse to participate

Primary outcomes:
measure: Intention to become an organ donor
timeFrame: within 3 months
Secondary outcomes:
measure: Taking a donor card after the interview
timeFrame: Immediately at the end of the interview (i.e. that day, an average of 10-15 minutes after consenting to participate))
Other outcomes:
Locations:
city: Manipal
country: India
facility: Manipal University
state: Karnataka
city: Dublin
country: Ireland
facility: RCSI
city: Perdana
country: Malaysia
facility: RCSI Perdana University
state: Serdang
city: Stirling
country: United Kingdom
facility: University of Stirling
Study officials:
affiliation: Royal College of Surgeons in Ireland
name: Frank Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03254862: Different Stimulation Patterns to Reduce Muscle Fatigue During FES
Official title: Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Functional electrical stimulation
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-08-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI).

Detailed description: Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications. The main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes. Three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes during different patterns of stimulation will be evaluated in this study.

Eligibility criteria: Inclusion Criteria:

* incomplete spinal cord injury
* able to give informed consent
* able to sit up in a chair

Exclusion Criteria:

* female subjects who are pregnant
* significant history of autonomic dysreflexia
* unable to give informed consent
* individuals who have a cardiac history
* individuals who have significant cognitive impairment
* individuals with muscular abnormality
* individuals who have significant contractures in the lower extremities
* individuals who have a rash or infection at the site of electrode placement (gastrocnemius for both legs)
* individuals who are hypersensitive to electrical stimulation
* individuals who are presently involved in another study which has overlap with the methodology and/or outcomes of the studies

Primary outcomes:
measure: Muscle contraction ability
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Normalized Fatigue Index (NFI)
timeFrame: Baseline to 6 weeks
measure: Fatigue Time Interval (FTI)
timeFrame: Baseline to 6 weeks
measure: Twitch-Tetanus Ratio response (ΔTTR)
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
Study officials:
affiliation: University of Glasgow
name: Henrik Gollee, DipIng PhD
role: STUDY_DIRECTOR
References: