louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05644106: Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
Official title: Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Disorders
Keywords: Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids


Eligibility criteria: Inclusion Criteria:

1. Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
2. Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
3. Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment

Exclusion Criteria:

1. In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
2. Acoustic nerve lesions or central nervous system disease
3. Those suspected of having false hearing loss
4. Those who have secondary benefits related to clinical trials

Primary outcomes:
measure: The hearing level threshold (decibel) after each treatment
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03844906: A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Multiple Doses of SAGE-718 Using Ketamine Challenge to Evaluate the Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-02-19
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: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion Criteria:

1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

Primary outcomes:
measure: Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
timeFrame: From Day 1 through Day 11
measure: Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
timeFrame: From Day 1 through Day 11
Secondary outcomes:
measure: Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
timeFrame: Between Baseline and Day 26
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Sage Investigational Site
state: California
city: Berlin
country: United States
facility: Sage Investigational Site
state: New Jersey
Study officials:
References:
Clinical trial NCT00734006: Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study
Official title: Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Cortico-cortical
connectivity
Transcranial
Magnetic
Stimulation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy right-handed men aged 18-35 who do not smoke or have any metallic implants may be eligible for this study.

Brief summary: The aim of the proposed research is to measure the effect of drug-induced sedation on the functional connectivity between brain regions as indicated by EEG signal transmission within the human brain. The results of this study will help to identify the neurophysiological correlates of changes in conscious experience that occur during drug-induced sedation.

Detailed description: In the proposed experiments cortical areas will be stimulated using low frequency, low-amplitude transcranial magnetic stimulation (TMS) in healthy human subjects during wakefulness and during drug-induced responsive sedation and unresponsive sedation. Simultaneously, high-density electroencephalography (Hd-EEG) will be recorded to evaluate the temporal and spatial characteristics of evoked responses and induced rhythms over the cortex.

Eligibility criteria: Inclusion Criteria:

* Healthy right-handed men
* Aged 18-35
* Non-smokers
* No metallic implants

Exclusion Criteria:

* Younger than 18 or over the age of 35.

Primary outcomes:
measure: Defining the neurophysiological conditions that are necessary for conscious experience.
timeFrame: Immediate
Secondary outcomes:
measure: Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia.
timeFrame: Immediate
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Pearce, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00138606: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2311 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2311
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety of vildagliptin in combination with insulin during 52 weeks of treatment
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change in HbA1c between 24 weeks and 52 weeks
measure: Change in fasting plasma glucose between 24 weeks and 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change from baseline in mean daily insulin dose at 52 weeks
measure: Change from baseline in mean daily number of insulin injections at 52 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Fonseca V, Baron M, Shao Q, Dejager S. Sustained efficacy and reduced hypoglycemia during one year of treatment with vildagliptin added to insulin in patients with type 2 diabetes mellitus. Horm Metab Res. 2008 Jun;40(6):427-30. doi: 10.1055/s-2008-1058090. Epub 2008 Mar 11. No abstract available.
Clinical trial NCT02720406: Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.
Official title: Topical Ketamine by Neubulization Method in Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations

Detailed description: In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study

Exclusion Criteria:

* patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.

Primary outcomes:
measure: Postoperative analgesic consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: 24 hours postoperative
measure: Ketamine serum levels to exclude systemic absorption of topical ketamine.
timeFrame: 120 min after receiving Ketamine
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut Governorate
Study officials:
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03148106: Hand Rehabilitation Study for Stroke Patients
Official title: Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Upper Extremity Paresis
Disability Physical
Chronic Stroke
Motor Disorders
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.

Exclusion Criteria:

* Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score \>3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a pacemaker.

Primary outcomes:
measure: Change in Finger Fractionation
timeFrame: Baseline and immediately post-stimulation
Secondary outcomes:
measure: Change in Modified Ashworth Scale
timeFrame: Baseline and immediately post-stimulation
measure: Change in Arm Research Action Test
timeFrame: Baseline and immediately post-stimulation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Karunesh Ganguly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06633406: Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Official title: Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: a Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: General Anaesthesia During Pregnancy
Keywords: anaesthesia
anaesthesia-induced neurotoxicity
pregnancy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from women who delivered in one of the participating hospitals

Brief summary: Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy. While these surgeries are necessary, there is a concern that the anaesthesia might affect the baby's brain development. However, there isn't enough research to know for sure how this exposure might impact the child's intelligence or behavior later in life.

The goal of this cohort study is to compare the intelligence and neurodevelopmental outcome of children prenatally exposed to general anaesthesia for maternal abdominal surgery with those of unexposed children.


Eligibility criteria: Prenatal anaesthesia exposure:

Inclusion Criteria:

* Prenatal anaesthesia exposure: Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
* No prenatal anaesthesia exposure: Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
* Children born in 2000-2023
* (Parental) informed consent

Exclusion Criteria:

* Children whose mothers underwent obstetric surgery or foetal surgery/interventions during the same pregnancy.
* No Dutch-speaking children
* Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,...), history of head trauma, major congenital birth defects

Primary outcomes:
measure: Wechsler full-scale intelligence quotient
timeFrame: 1,5 hours (duration of intelligence testing and completion of questionnaires)
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Flanders
Study officials:
affiliation: UZ Leuven
name: Sarah Devroe, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03976206: Very Small Embryonic-like Stem Cells for Facial Skin Antiaging
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Stem Cell Transplant Complications
Skin Inflammation
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
First posted: 2019-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the experimental group, VSELs will be injected in left preauricular area of every volunteer, followed by skin pathology to compare the improvement of skin aging with the skin of right preauricular area. In the control group, platelet-rich plasma will be injected to the left preauricular area of every volunteer.
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to facial skin antiaging.

Detailed description: VSELs come from the patient's peripheral blood, and will be injected in left preauricular area, followed by skin pathology to compare the improvement of skin aging. Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from bilateral preauricular areas for morphologic analysis by optical and electron microscopy. Histologic analysis of skin biopsy specimens was performed by hematoxylin and eosin, picrosirius red (for visualization of collagen), and orcein (for visualization of elastic fibers) staining.

Eligibility criteria: Inclusion Criteria:

• Healthy volunteers with anti-aging willingness

Exclusion Criteria:

* Metabolic and systemic diseases such as diabetes and atherosclerosis
* Facial skin diseases such as herpes, eczema, skin rash, systemic lupus erythematosus, dermatomyositis, connective tissue disease
* Endocrine disorders and cancer patients Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 week
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 week
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 week
Secondary outcomes:
measure: Short-term changes in skin histopathology
timeFrame: 3-6 months after injection
measure: Long-term changes in skin histopathology
timeFrame: 12 months after final injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00973206: Factors Influencing Cardiovascular Prognosis
Official title: Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Mortality
Keywords: cardiovascular morbidity
mortality community study
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers,community sample, residents of a certain town

Brief summary: The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.

Detailed description: Inclusion criteria

* Age \> 50 years volunteers (2 towns of 15000 residents one in the north and one in the south of Greece)
* End points
* 5-10 years cardiovascular morbidity and mortality

Measurements at baseline

* Anthropometrics

  * Age (M\>55 years; W\>65 years)
  * Weight-height- BMI
  * Abdominal obesity (Waist circumference\>102 cm(M), \>88cm (W) Family history
  * Family history of premature CV disease (M at age\<55 years; W at age\<65 years)

History

* Smoking
* Diabetes Mellitus,
* Established Heart disease: myocardial infarction; angina; coronary revascularization; heart failure
* Established renal disease \[diabetic nephropathy; renal impairment (serum creatinine M\>133, W\>124 mmol/l); proteinuria (\> 300 mg/24 h)\]
* Cerebrovascular disease: ischaemic stroke; cerebral haemorrhage; transient ischaemic attack
* Peripheral artery disease
* Advanced retinopathy: haemorrhages or exudates, papilloedema
* Treatment

Measurements

* Measurements Blood pressure

  * Clinic BP
  * 24h ABPM
  * Home BP

Heart

* Electrocardiographic LVH
* Echocardiographic LVH

Vessels

* Carotid wall thickening or plaque
* Carotid-femoral pulse wave velocity
* Ankle/brachial BP index

Lipids or other risk factors

* Total cholesterol, Tg, HDL, LDL
* Plasma creatinine, estimated glomerular filtration rate
* Fasting plasma glucose or postload plasma glucose
* Microalbuminuria and albumin-creatinine ratio
* Glucose tolerance test

  * Follow up each 3 year with all the above measurements

Eligibility criteria: Inclusion Criteria:

* All age \>50 volunteers

Exclusion Criteria:

* None

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 10 years
Secondary outcomes:
measure: Hospitalization for CV events
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: AUTH
name: Vasilios Kotsis, Prof
role: STUDY_CHAIR
References: