louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02176889: A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
Official title: A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Lactospore
Bacillus coagulans
Safety
Probiotic
Healthy Adults
Tolerability
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sabinsa Corporation
First posted: 2014-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether Lactospore is safe in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years of age
* If female, subject is not of child bearing potential or female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
* Healthy as determined by laboratory results and medical history
* Normal BMI 18.5 - 29.9 kg/m2
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Subject has any clinically significant medical conditions
* Subject requires the use of prescribed medications (other than birth control)
* Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
* Participation in a clinical research trial within 30 days prior to randomization
* Clinically significant abnormal laboratory results at screening
* Allergy or sensitivity to test product ingredients
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Primary outcomes:
measure: Safety and Tolerability: Lab parameters
timeFrame: Over 30 days
measure: Safety and Tolerability: Anthropometric safety measures
timeFrame: Over 30 days
measure: Safety and Tolerability: Number of Adverse Events
timeFrame: Over 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858489: Concordance Between Mini-Mental Stats Examination (MMSE) and an Adapted Version of the MMSE in Reunion Island Population (MMS-Run)
Official title: Concordance Between Mini-Mental Stats Examination (MMSE) and an Adapted Version of the MMSE in Reunion Island Population (MMS-Run) : Preliminary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Deficit
Keywords: Neurocognitive Deficit
Neurocognitive Impairment
Major neurocognitive disorder
Dementia
Geriatric
Senior
Illeteracy : Mini Mental State Examination
Eldery
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected in geriatric and physical medicine and rehabilitation departments at CHU de La Réunion.

Brief summary: Illeteracy concerns more than 38% of Réunion Island's people older than 65 years old, which makes it an important risk factor for dementia and a limit to neurocognitive test's administration.

The MMSRun is a Mini Mental State Examination's version adapted to illeteracy and Réunionese culture, inspired by Hindi Mental State Examination's work. It allows a way better participation during neurocognitive evaluation, but it has never been validated.

This study is a peliminary study to a validation, where the concordance between scores obtained from MMSRun and from the consensual version of Mini Mental State Examination proposed by GRECO (Groupe de Réflexion sur les Evaluations Cognitives) - the only french version validated - on a hospitalized and eldery population will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patient who needs a cognitive evaluation by MMSe/MMS-RUN during usual medical care
* Patient born and living in Réunion Island
* Patient hospitalized in geriatrics department or in the departement of physical medecine and rehabilitation
* Patient who agrees to participate in the study and who does not oppose to the use of his data

Exclusion Criteria:

* Patient with hearing and visual disorder that can interfere in cognitive test administration
* Patient with altered state of consciousness (Glasgow score different of 15)
* Patient diagnosed or having symtoms compatible with a psychiatric pathology with psychosis (altered perception of reality)
* Patient with a current and severe addiction to Alcohol or any other drug (smoking excluded)
* Patient deprived of liberty by judicial or administrative decision and patient under curatorship or guardianship

Primary outcomes:
measure: Total scoring of MMSE
timeFrame: Day 0
measure: Total scoring of MMS-RUN
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
Study officials:
affiliation: CHU de La Réunion
name: Bénédicte CASALONGA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053789: Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease
Official title: Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine (Lacrimera®) in Moderate-to-severe Dry Eye Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eye Diseases
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 48
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this pilot study is to evaluate the best treatment regime of Chitosan-N-Acetylcysteine (Lacrimera®) compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Detailed description: The present pilot study seeks to investigate the best fitting treatment regime of moderate-to-severe DED with C-NAC compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) by applying a randomized, prospective, adaptive, controlled design.

Eligibility criteria: Inclusion Criteria:

* Age older than 22 years
* Corneal staining (marked to severe; NEI grading scale \>=10)

Exclusion Criteria:

* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months to screening
* Preceding refractive corneal surgery (e.g. LASIK)
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)

Primary outcomes:
measure: Duration of treatment
timeFrame: 1 month
Secondary outcomes:
measure: Change in BUT (Break Up Time)
timeFrame: 1 month
measure: Change in NI-BUT (Non-invasive Break Up Time)
timeFrame: 1 month
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 1 month
measure: Flourescein staining / Lissamin green staining grading using the NEI Score (National Eye Institute)
timeFrame: 1 month
measure: Change in number of MMP-positive eyes (Matrix Metallopeptidase 9)
timeFrame: 1 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, PrimUnivPrDr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05603689: Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude
Official title: Effect of a Four-week Isocaloric Ketogenic Diet on Physical Performance at Very High Altitude: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Dieting
Altitude Hypoxia
Physical Activity
Lead sponsor: Clinique Romande de Readaptation
Sponsor class: NETWORK
First posted: 2022-11-03
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. The investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia and the possibility of evaluating ICKD performance benefits with a maximal graded exercise bike test under hypoxia and collected data on the effect of the diet on performance markers and arterial blood gases.

Detailed description: In a randomised single-blind cross-over model, 6 recreational mountaineers (age 24 to 44 years) will complete a 4-week ICKD followed or preceded by a 4-week habitual mixed western diet (HD). Performance parameters (VO2max, lactate threshold \[LT\], peak power \[Ppeak\]) and arterial blood gases (PaO2, PaCO2, pH, HCO3-) will be measured at baseline under two conditions (normoxia and hypoxia) as well as after a 4-week HD and 4-week ICKD under the hypoxic condition.

Eligibility criteria: Inclusion Criteria:

* Recreational mountaineers
* Familiarity with altitude (\>2500 m above sea level) and males/females 20 to 45 years old.

Exclusion Criteria:

* high training load (such as professional athletes) or new planned training
* dietary restrictions.

Primary outcomes:
measure: Performance test under hypoxic conditions
timeFrame: after 4 weeks of diet
Secondary outcomes:
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: CRR
Study officials:
affiliation: HESso
name: Lara Allet, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01082289: Digoxin Drug-Drug Interaction With Lurasidone HCl
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Determine the Effect of Repeated Dose Lurasidone 120 mg Administration on the Pharmacokinetics of Orally Administered Digoxin 0.25 mg in Patients With Schizophrenia or Schizoaffective Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Lurasidone
Schizophrenia
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to evaluate the pharmacokinetic profile of digoxin when administered alone and when administered with repeated dose of lurasidone 120mg.


Eligibility criteria: Inclusion Criteria:

* Male and female 18 to 65 years of age
* BMI \>= 19.5 and \<= 37 kg/m2
* No clinically relevant abnormal laboratory values

Exclusion Criteria:

* History or presence of renal or hepatic insufficiency
* Participated in a clinical trial in the past 30 days
* Use of con meds that prolong the QT/QTc taken within 28 days prior to study drug administration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: California Clinical Trials
state: California
Study officials:
affiliation: California Clinical Trials
name: Marina Bussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05966389: Functional MRI to Assess Brain Damage in Cardiac Arrest Patients
Official title: Assessment of Cerebral Microcirculation, Blood-brain Barrier, and Cerebral Oxygenation Damage in Patients with Cardiac Arrest Using Functional MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Brain Injuries
Keywords: Cardiac arrest
functional Magnetic Resonance Imaging
cerebral microcirculation
blood-brain barrier
cerebral oxygenation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.

Brief summary: This is a single-center, observational study. Patients after successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72h and hemodynamics remained stable for 24h, the post-resuscitated patients underwent functional magnetic resonance imaging (fMRI) examination. During the examination, the supervising physician accompanied the patient and monitored the patient's vital signs using a magnetic resonance monitoring system (Siemens Healthcare Prism, Germany). Patients who are on ventilators are mechanically ventilated using a magnetic ventilator (HAMILTON-MRI, USA). In additional to conventional sequences, fMRI is performed for diffusion-prepared pseudo-continuous arterial spin labeling (DP-pCASL) and blood oxygenation level dependent functional magnetic resonance imaging (BOLD-fMRI). These MRI sequences allow quantitative assessment of the patients' cerebral microcirculation, blood-brain barrier, and cerebral oxygenation status. Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years.
* sustained hemodynamic stability for ≥24h.
* the patients were unconscious and not able to obey verbal commands.
* Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC).

Exclusion Criteria:

* Patients with hemodynamic instability.
* Patients who could not complete cranial MRI examination for special reasons.
* Patients during pregnancy.
* Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
* Patients whose family members did not agree to be enrolled.

Primary outcomes:
measure: Neurologic prognosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chaoyang hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00167089: Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses
Official title: Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hemiplegia
Gait
Ambulation training
Neurologic physical therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients.

Detailed description: Restoration of independent ambulatory ability is one of the most common functional goals of patients with hemiplegia after stroke. Ambulation training, therefore, is an important part of physical therapy intervention for these patients. Conventional neurologic physical therapy for ambulation training, based sorely on neurophysiology, prohibits early ambulation experience after stroke in attempt to avoid the development of abnormal gait patterns. Such an approach has been shown to be limited in helping these patients regain independent ambulatory ability.

Eligibility criteria: Inclusion Criteria:

* between 40 and 75 years old
* first stroke with R't side hemiplegia due to middle cerebral artery occlusion and received acute treatment at NTUH
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
* able to ambulate independently in parallel bars and having no independent ambulation ability outside parallel bars

Excursion criteria:

* having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke

Primary outcomes:
measure: To investigate walking speed and stride length as the representation of ambulation ability
timeFrame: 3 months
Secondary outcomes:
measure: To investigate the the co-activation duration between the activity of hamstring and quadriceps, and tibialis anterior and gastrocnemius joints, the level of symmetry in step length and stance/swing duration ratio between the affected and unaffected legs
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
state: Province of China
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Fang Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366989: INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
Official title: INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthrodesis
Degenerative Arthritis
Rheumatoid Arthritis
Complications; Arthroplasty, Mechanical
Keywords: Total Ankle Arthroplasty
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2011-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Brief summary: The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

Detailed description: The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters

Eligibility criteria: Inclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Exclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Primary outcomes:
measure: Radiographic Evaluation
timeFrame: Post operarative 1.2 -3.1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Michael Bolognesi, MD
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Bolognesi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03333889: Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone
Official title: Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hybrid Crowns on Single Implants in Esthetic Zone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?


Eligibility criteria: Inclusion Criteria:

1. Patients above 18 years old.
2. Patients able to read and sign the informed consent document.
3. Medically free patients or with controlled systemic disease.
4. Patients with good bone quality and quantity evaluated using C.B.C.T.
5. Patients willing to return for follow-up examinations and evaluation.
6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.
2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
3. Pregnant women to avoid any complication that may occur in dental office.
4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
5. Psychiatric problems or unrealistic expectations.
6. Multiple adjacent missing teeth.
7. Patients with bad oral hygiene. -

Primary outcomes:
measure: patient satisfaction
timeFrame: 12 months
Secondary outcomes:
measure: crestal bone loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Inas adel mahmoud
Study officials:
References: