louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00219245: An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Official title: A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury With Persistent Cognitive Deficits
Keywords: Traumatic brain injury, head trauma, rivastigmine, cognitive deficits
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.


Eligibility criteria: Inclusion Criteria:

* Have a deficit in the areas of attention and/or memory.
* Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
* Be at least 12 months post brain injury;

Exclusion Criteria:

* A history of a major brain surgery;
* A penetrating brain injury (e.g., gun shot wound);
* A current diagnosis of epilepsy;
* Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
* Previous exposure to rivastigmine.

Primary outcomes:
measure: Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
measure: Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment
Secondary outcomes:
measure: Changes in cognitive functioning from baseline to week 26
measure: Changes in behavior from baseline to week 26
measure: Changes in depression from baseline to week 26
measure: Changes in quality of life from baseline to week 26
measure: Changes in overall functioning from baseline to week 26
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00115245: Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Official title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2005-06-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.


Eligibility criteria: Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
* Detectable serum HBsAg at the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
* Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
* Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Clayton
country: Australia
city: Wooloongabba
country: Australia
city: Calgary
country: Canada
city: Toronto
country: Canada
city: Winnipeg
country: Canada
city: Hong Kong
country: China
city: Paris
country: France
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
References:
citation: Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.
Clinical trial NCT05551845: Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）
Official title: Blood Pressure Monitor（Model：KD-595） Clinical Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal blood pressure and hypertensive patients over 12 years old

Brief summary: The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device.

Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm


Eligibility criteria: Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial

Primary outcomes:
measure: blood pressure monitor accuracy
timeFrame: 30minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
References:
Clinical trial NCT06363045: Comparative Study of the NIDEK TONOREF III with Predicate Devices
Official title: Comparative Study of the NIDEK TONOREF III with the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III with the NIDEK CEM-530 for Pachymetry Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.


Eligibility criteria: Exclusion criteria

1. Subjects with only one functional eye;
2. Those with one eye having poor or eccentric fixation;
3. Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
4. Microphthalmos;
5. Buphthalmos;
6. Contact lens wearers;
7. Dry eyes;
8. Lid squeezers - blepharospasm;
9. Nystagmus;
10. Keratoconus;
11. Any other corneal or conjunctival pathology or infection.
12. central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)

Primary outcomes:
measure: Equivalent to legally-marketed devices
timeFrame: One or two study visits per subject. One visit is less than two hours.
measure: Equivalent to the pachymeter function
timeFrame: One or two study visits per subject. One visit is less than two hours.
Secondary outcomes:
measure: The numbers of adverse events
timeFrame: One or two study visits per subject. One visit is less than two hours.
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
Study officials:
affiliation: Nidek Co. LTD.
name: Tadakazu Ichimura
role: STUDY_DIRECTOR
References:
Clinical trial NCT03006445: Study of FYU-981 in Hyperuricemia With or Without Gout
Official title: Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperuricemia With or Without Gout
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mochida Pharmaceutical Company, Ltd.
First posted: 2016-12-30
Enrollment: 330
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 confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.


Eligibility criteria: Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg

Primary outcomes:
measure: Percent reduction from baseline in serum urate level at the final visit
timeFrame: 34 or 58 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T. Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):80-91. doi: 10.1007/s10157-019-01831-5. Epub 2019 Dec 26.
Clinical trial NCT04479345: Knowledge, Attitude and Practice of Gastrointestinal Endoscopists Toward PPE in COVID-19 Era
Official title: Knowledge, Attitude and Practice of Gastrointestinal Endoscopists Toward PPE in COVID-19 Era
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knowledge, Attitudes, Practice
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GIT endoscopists

Brief summary: Assessing the knowledge and practice of GIT endoscopists toward the use of PPE.

Detailed description: An online questionnaire assessing the knowledge and practice of GIT endoscopists toward the use of PPE will be used.

Eligibility criteria: Inclusion Criteria:

* GIT endoscopists

Exclusion Criteria:

* Refuse to participate

Primary outcomes:
measure: The knowledge and attitude toward PPE during endoscopy
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01543945: Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
Ambulatory
Gynecologic laparoscopy
Incidence of postoperative nausea and vomiting.
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.


Eligibility criteria: Inclusion Criteria:

* Ambulatory gynecologic laparoscopy
* Age 18-45 years
* ASA class 1-2

Exclusion Criteria:

* The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
* History of antiemetic, anesthetic and analgesic drugs allergy
* Pregnancy or breast feeding
* Body mass index \>34 kg/square metre

Primary outcomes:
measure: Incidence of PONV in ambulatory gynecologic laparoscopy
timeFrame: four year
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Anesthesiology Department, Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Anesthesiology department, Faculty of Medicine, Prince of Songkla University Thailand
name: Thanyamon Asampinwat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630845: Comparison of Whole Body DWI to FDG PET
Official title: Comparison of Whole Body DWI to FDG PET Using PET/MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Keywords: Imaging Study
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Society of Abdominal Radiology
name: GE Healthcare
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.

Detailed description: PRIMARY OBJECTIVE:

I. Correlation of DWI and FDG to detect disease.

SECONDARY OBJECTIVE:

I. Inter-reader variability of DWI interpretation by region.

OUTLINE:

Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
3. Ability to understand a written informed consent document, and the willingness to sign it.
4. Diagnosis of metastatic cancer.

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel

Primary outcomes:
measure: Proportion of lesions characterized as positive
timeFrame: Up to 6 months
Secondary outcomes:
measure: Inter-reader variability of diffusion weight imaging (DWI) interpretation
timeFrame: Up to 6 months
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: Thomas A Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425445: Quantitative Assessment of Orofacial Muscle Function in FSHD
Official title: Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facioscapulohumeral Muscular Dystrophy
Lead sponsor: University of Mons
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 22
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs).

Our hypothesis is the following:

- The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals


Eligibility criteria: Inclusion Criteria:

* Genetic diagnosis of FSHD type 1 and/or type 2

Exclusion Criteria:

* Pregnant women
* Presence of other associated neuromuscular conditions
* Any unstable interfering clinical situation

Primary outcomes:
measure: The pressure drop
timeFrame: The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Mons
country: Belgium
facility: University of Mons
state: Hainaut
Study officials:
affiliation: University of Mons
name: Alexandre Legrand (PhD, MD, principal investigator)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04957745: Understanding Visual Confusion Using Stereoscopic Displays
Official title: Monocular Visual Confusion for Field Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplopia
Binocular Vision Suppression
Binocular; Fusion, With Defective Stereopsis
Monocular Diplopia
Keywords: Visual confusion
Rivalry
Head mounted display
Stereoscopic displays
Binocular vision
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2021-07-12
Enrollment: 13
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants in the group will see all three interventions (peripheral targets in three visual confusion conditions) in a randomized order. In this study design, each participant will serve as their own control, and the order of the interventions will be randomized to account for potential carryover or ordering effects. There will be no comparison or control group. The outcome will be compared through a within-subject analysis.
Primary purpose: BASIC_SCIENCE

Brief summary: In this research study we want to test how people understand a visual scene when the same image is presented to both the eyes, but portions of these images are altered in terms of contrast, depth or in some cases motion.


Eligibility criteria: Inclusion Criteria:

* Better than 20/40 visual acuity in the worse eye
* No restrictions of the peripheral visual field: (at least 60 degrees vertically and 40 degrees horizontally)
* At least 14 years of age (no upper age limit)
* Able to give voluntary, informed consent
* Able to understand English
* Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)

Exclusion criteria:

* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
* Being unable to complete sessions lasting 2-3 hours

Primary outcomes:
measure: Percentage of Total Viewing Time That Peripheral Target is Perceived
timeFrame: Approximately 1-2 sessions to finish total 6 trials, up to 2 hours for each session, any time within the 4month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute
name: JaeHyun Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364545: Ketogenic Diets for Symptoms of Parkinson's Disease
Official title: Ketogenic Diets for Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Parkinson's disease is a progressive condition that harms nerve cells of the brain (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep brain stimulation) improve certain symptoms but are not thought to improve the underlying neurodegenerative disease process (they are not a "cure"). The cause of Parkinson's disease is unknown. However, some evidence suggests that tiny structures in the investigators cells called "mitochondria" might be involved. Mitochondria are the powerhouses that produce fuel for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a food called 'ketones' might be able to enhance the function of mitochondria and improve Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study, the investigators would like to investigate this possibility by giving patients with Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will then assess if this improves symptoms of Parkinson's disease.

The study design is a prospective, double blinded, randomised, controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patients with Primary Parkinson's disease fulfilling UK Brain Bank criteria
* Age of onset of Parkinson's disease symptoms \> 40 years old
* Duration of symptoms over 2 years

Exclusion Criteria:

* Dementia
* Active psychosis
* Deep brain stimulation or apomorphine infusion
* Severe motor fluctuations
* Significant metabolic or uncontrolled medical cormorbidity

Primary outcomes:
measure: Unified Parkinson's Disease rating Scale, part III (motor)
timeFrame: 5 days
Secondary outcomes:
measure: Timed motor tasks as per CAPSIT
timeFrame: 5 days
measure: Computerised reaction time and cogntive tests
timeFrame: 5 days
measure: Unified Parkinson's disease rating scale, parts I, II, IV
timeFrame: 5 days
measure: Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
timeFrame: 5 days
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
References: