louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496677: Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
Official title: A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: volunteer
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Detailed description: This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).

Eligibility criteria: Inclusion Criteria:

* Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
* BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

Elderly Group

* Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)

Control Group

* Medically stable with no clinically significant abnormalities

Exclusion Criteria:

* Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
* Previous inclusion in a TR-701 FA or TR-701 clinical study
* ECG finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at Screening
* Female subjects whom are pregnant, lactating or breastfeeding

Primary outcomes:
measure: Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Trius Investigator Site 001
state: Florida
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Clin Pharmacol Drug Dev. 2018 Sep;7(7):788-794. doi: 10.1002/cpdd.426. Epub 2018 Jan 10.
Clinical trial NCT02588677: Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
Official title: Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic Lateral Sclerosis (ALS) - masitinib
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to compare the efficacy and safety of masitinib in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

Detailed description: Masitinib is novel tyrosine kinase inhibitor that targets microglia and mast cells through inhibiting a limited number of kinases. Masitinib blocks microglia proliferation and activation, and mast cell-mediated degranulation, the release of cytotoxic substances that might further damage the motor nerves.

There are two distinct populations of ALS patients: population of "Normal progressors" and population of "Faster progressors". Targeted population for primary analysis is population of "Normal progressors".

"Normal progressors" are ALS patients whose progression of ALSFRS-R score before randomization is less than 1.1 point per month.

Eligibility criteria: Inclusion Criteria:

Main inclusion criteria:

1. Familial or sporadic ALS
2. Patient diagnosed with probable of definite ALS
3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening

Exclusion Criteria:

1. Patient who underwent tracheostomy and/or gastrostomy

Primary outcomes:
measure: Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised
timeFrame: From baseline to week 48
Secondary outcomes:
measure: Change of Forced Vital Capacity (FVC)
timeFrame: From baseline to week 48
measure: Progression Free Survival
timeFrame: Time from the randomization date until the earliest date for a decline of more than 9-points in ALSFRS-R score, asssesd over a maximum of 60 months
measure: Overall Survival
timeFrame: Time from the randomization date until death, asssesd over a maximum of 60 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Carlos III
Study officials:
affiliation: Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain
name: Jesus S Mora, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mora JS, Bradley WG, Chaverri D, Hernandez-Barral M, Mascias J, Gamez J, Gargiulo-Monachelli GM, Moussy A, Mansfield CD, Hermine O, Ludolph AC. Long-term survival analysis of masitinib in amyotrophic lateral sclerosis. Ther Adv Neurol Disord. 2021 Jul 19;14:17562864211030365. doi: 10.1177/17562864211030365. eCollection 2021.
Clinical trial NCT00257777: Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Official title: Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Coronary Artery Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-11-23
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide. No larger prospectively randomized studies comparing the two methods have been reported. The aim of this study is to collect a large number of clinical data to create a proper basis for evaluation of the two techniques.

Detailed description: All patients admitted for aortic valve replacement with or without concomitant CABG and operated by E.Ø. or G.T. are included in the study. All preoperative, operative and postoperative data are prospectively recorded, focusing on clinical outcome parameters

Eligibility criteria: Aortic valve replacement

Primary outcomes:
measure: Myocardial function,
measure: postoperative ventilatory support, postoperative arrhythmia,
measure: blood transfusions,
measure: physical recovery,
measure: mortality.
Secondary outcomes:
measure: Costs
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: RRHF
Study officials:
affiliation: Oslo University Hospital
name: Eivind Øvrum, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04959877: Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia
Official title: Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphagia
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with oropharyngeal dysphagia who require speech therapy

Brief summary: When reviewing the literature, the need to investigate the health education of patients with dysphagia and their family members / caregivers has been detected. Numerous articles mention or it can be inferred from them that an education or training has been carried out for the patient and caregivers, but the investigators have not found any that specifically focuses on this aspect of the intervention. Only in some Clinical Practice Guidelines is the need for health education included


Eligibility criteria: Inclusion Criteria:

* People between 18 and 99 years old diagnosed by videofluoroscopy of oropharyngeal dysphagia and who are candidates for speech therapy treatment for this reason.
* Knowledge of the language sufficient to understand the audiovisual material on health education available at: logopediasantpau.wordpress.com
* Have the necessary technological tools to carry out the telematic processing (electronic device with Internet access and WhatsApp) and know how to use them or have a family member / direct caregiver with basic technological skills.
* Signature of the informed consent

Exclusion Criteria:

* Moderate or severe cognitive impairment already known from the medical history or evaluated with the MoCA test in the absence of a family member or caregiver.
* Having undergone speech therapy treatment for oropharyngeal dysphagia in the last year.
* Not signing the informed consent.

Primary outcomes:
measure: Dysphagia Severity Rating Scale
timeFrame: up to 1 year
measure: Functional oral intake scale
timeFrame: up to 1 year
measure: Penetration Aspiration Scale
timeFrame: up to 1 year
measure: Bolus Residual Scale
timeFrame: up to 1 year
Secondary outcomes:
measure: SwalQOL
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la santa creu i sant Pau
Study officials:
References:
Clinical trial NCT04187677: Effect of Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life After Wrist Surgery
Official title: Investigation of the Effect of Proprioceptive Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life in Individuals Undergoing Open Carpal Tunnel Relaxation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proprioception
Keywords: sensory
carpal tunnel syndrome
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the benefits of sensory training for participants who are included in rehabilitation after carpal tunnel surgery.


Eligibility criteria: Inclusion Criteria:

* SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.

Exclusion Criteria:

* The presence of nerve entrapment other than the median nerve (any sensory / motor deficits in the ulnar or radial nerve),
* Wrist injury history (fractures, carpal instabilities),
* Previous surgery in the hand or wrist region,
* Traumatic and recurrent Carpal Tunnel Syndrome, inflammation of the tendon sheath or the presence of general active inflammation

Primary outcomes:
measure: Joint Position Matching
timeFrame: Baseline (First day)
measure: Purdue Pegboard Test
timeFrame: Baseline (First day)
measure: Activity Limitation
timeFrame: Baseline (First day)
measure: Health-Related Quality of Life
timeFrame: Baseline (First day)
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: SANKO University
Study officials:
References:
Clinical trial NCT03871777: Dietary Nitrate Intake in Vegetarians and Omnivores
Official title: Dietary Intake of Inorganic Nitrate in Vegetarians and Omnivores and Its Impact on Blood Pressure, Resting Metabolic Rate and the Oral Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: nitrate
vegetarian
nitrite
oral microbiome
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: University of the West of Scotland
First posted: 2019-03-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Vegetarian diets are commonly associated with lower blood pressure levels. This has been related to greater consumption of inorganic nitrate, since vegetables are the main source of this anion. Dietary nitrate is reduced to nitrite by commensal bacteria in the mouth, which in turn leads to increased circulatory nitrite availability. Nitrite can form nitric oxide by several pathways promoting a reduction in the vascular tone and lower blood pressure.


Eligibility criteria: Inclusion Criteria:

* Healthy vegetarians (vegans and ovo-lacto vegetarians) following this dietary pattern for at least a year.
* Health omnivores

Exclusion Criteria:

* Smokers
* Individuals taking any medications or recreational drugs.
* Individuals with pre-existing medical conditions such as hypertension, diabetes, dyslipidaemia or dental conditions (gingivitis).
* Individuals using mouthwash or tongue scrapes were excluded from this study

Primary outcomes:
measure: Dietary nitrate intake
timeFrame: 7 days
measure: Concentration of nitrate and nitrite in plasma and saliva
timeFrame: 7 days
measure: Change in blood pressure
timeFrame: 7 days
measure: Change in oral nitrate-reducing capacity
timeFrame: 7 days
measure: Change in Resting Energy Expenditure
timeFrame: 7 days
measure: Change oral microbiome
timeFrame: 7 days
measure: Change in blood biomarkers
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Laboratory of Nutrition, Exercise & Health
state: Devon
Study officials:
affiliation: University of Plymouth
name: Raul Bescos, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05362877: The Use of Earplugs on Temporomandibular Joint
Official title: The Effect of Earplugs on Myogenous Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Protective Devices
Temporomandibular Joint Disorders
Physical Therapy Modalities
Keywords: Splints
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Many therapeutic modalities have been advocated for the treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness.

Recently some commercial earplugs that claim to treat TMD have been introduced, however, there is no validated data regarding these appliances. Thus, this study aimss to evaluate the possible effect of earplugs on myogenous TMD.


Eligibility criteria: Inclusion Criteria:

* Pain in masticatory muscles for at least 3 months according to the DC/TMD
* Having a stable medication regimen for at least 1 month
* Age of 18-65 years
* Minimum pain intensity of 50 mm on a 100 mm visual analog scale (VAS)
* No concomitant systemic disease
* Natural posterior occlusion.

Exclusion Criteria:

* Undergoing physical therapy
* Using muscle relaxants and/or NSAIDs
* Previous TMD treatment more recently than one year
* Major psychosocial problems
* Undergoing orthodontic treatment
* Wearing removable prosthesis
* Pregnancy
* History of facial trauma.

Primary outcomes:
measure: Values of maximal mouth opening(millimeter)
timeFrame: 2 months
Secondary outcomes:
measure: Pain perception
timeFrame: 2 months
Other outcomes:
measure: Symptom Severity
timeFrame: 2 months
Locations:
city: Fatih
country: Turkey
facility: Istanbul university,Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02246777: Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
Official title: Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 32
Sex: ALL
Minimum age (years): 20
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 assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of normal tension glaucoma.
* Indicated for filtration surgery using Ex-PRESS®.
* Understand and provide Informed Consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant, lactating, or planning to be pregnant during the study period.
* Diagnosis of angle closure glaucoma or secondary glaucoma.
* History of glaucoma surgery.
* Ophthalmologic surgery within the past 6 months.
* Difficulty with applanation tonometry measurement.
* Corneal dystrophy.
* Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
* Severe blepharitis or dry eye.
* History of metal allergy.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: Month 3, Month 6, Month 12 Post-Operative
measure: Change From Baseline in IOP
timeFrame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
measure: Percent Change From Baseline in IOP
timeFrame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
measure: Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
timeFrame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
measure: Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
timeFrame: Month 3, Month 6, Month 12 Post-Operative
measure: Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
timeFrame: Month 3, Month 6, Month 12 Post-Operative
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Japan, Ltd for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT06457477: Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
Official title: The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50
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
Primary purpose: TREATMENT

Brief summary: This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.


Eligibility criteria: Inclusion Criteria:

* 1. 18 - 65 years old;
* 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
* 3. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
* 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.

Exclusion Criteria:

* 1. Cirrhosis;
* 2.platelet count \< 90×109/L, WBC count \< 3.0×109/L, neutrophil count \< 1.3×109/L, ALT \> ULN (40U/L), total bilirubin \> 2ULN;
* 3.History of or suspicion of hepatocellular carcinoma
* 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
* 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
* 6.Alcohol or drug abuse/dependence;
* 7.Investigator judges that the participants are not suitable for this study.

Primary outcomes:
measure: The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: Incidence of treatment-emergent adverse events/serious adverse events
timeFrame: 48 weeks
Secondary outcomes:
measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: the Fifth Medical Center, Chinese PLA General Hospital
state: Beijing
Study officials:
References: