louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02062515: Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
Official title: Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.

Detailed description: Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy
* ECOG performance status points (PS) is 0-2
* Liver function:

A (mild hepatic dysfunction):

A1) total bilirubin within normal limit (ULN), while AST\> ULN;

A2) total bilirubin within1.0-1 .5 × ULN;

B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN

* No malabsorption or other gastrointestinal disorders effecting drug absorption
* Life expectancy: more than 12 weeks.

Exclusion Criteria:

* Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
* Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
* Patients with active hepatitis and cirrhosis.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen Cancer Center
name: Hao Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059915: Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
Official title: An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
bioequivalence
bioavailability
oxycodone
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2014-02-11
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Positive urine drug test

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Concentration at time 24 hours (C24)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01872715: Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Official title: Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Papulopustular Rosacea
Keywords: Papulopustular Rosacea
Oracea
anti inflammatory doxycycline
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
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 characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.


Eligibility criteria: Inclusion Criteria:

* Men and women
* 25-70 years
* Diagnosis of papulopustular rosacea
* Eligible for Oracea treatment

Exclusion Criteria:

* Allergies to components of investigational product and/or hypersensitivity to tetracyclines
* Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
* Used topical rosacea treatment within 30 days prior to baseline visit
* Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
* Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
* Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
* Have planned surgical procedures during the course of the study
* Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
* At risk in terms of precautions, warnings, and contraindications

Primary outcomes:
measure: Rosacea Score on the Visual Analog Scale
timeFrame: Baseline, Weeks 2, 6, and 12
Secondary outcomes:
measure: Rosacea-Specific Quality of Life Index
timeFrame: Baseline, Weeks 2, 6, and 12
measure: Patient Global Assessment (PGA) of Rosacea Scores
timeFrame: Baseline, Weeks 2, 6, and 12
measure: Patient Satisfaction Question
timeFrame: Week 2, 6, and 12
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Stephens & Associates Dallas Research Center
state: Texas
Study officials:
References:
Clinical trial NCT04711915: Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Official title: Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Major Depressive Disorder
Depression
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy individuals and patients with major depressive disorder will participate in this study. Subjects will receive 0.1 mg/kg and 0.3 mg/kg DMT in a fixed order across 2 test days.
Primary purpose: OTHER

Brief summary: The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.

Detailed description: The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Eligibility criteria: Healthy controls inclusion criteria:

* Medically healthy
* Psychiatrically healthy

Healthy controls exclusion criteria:

* Unstable medical conditions
* Psychiatric illness

Depression inclusion criteria:

* Medically healthy
* Diagnosis of major depressive disorder

Depression exclusion criteria:

-Unstable medical conditions

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
measure: Change in Heart Rate
timeFrame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
measure: Change in Psychedelic Effects
timeFrame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
measure: Change in Anxiety
timeFrame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
measure: Drug Reinforcing Effects
timeFrame: +120 minutes after DMT administration
measure: Overall Tolerability assessed by the VAS
timeFrame: +120 minutes after DMT administration
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
References:
Clinical trial NCT01966315: The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit
Official title: The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Poor Quality Sleep
Sleep Deprivation
Sleep Arousal Disorders
Delirium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critical patients who take a sedative drugs (dexmedetomidine or midazolam).

Brief summary: The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.

Detailed description: Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep.

Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam.

The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.

Eligibility criteria: Inclusion Criteria:

* sedation patients with dexmedetomidine or midazolam
* over 18 years old

Exclusion Criteria:

* Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
* Brain infection
* Alcoholics
* Major Depression Disorder, Schizophrenia, Anxiety disorder
* Hearing loss

Primary outcomes:
measure: The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group
timeFrame: during ICU stay
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea
name: Young-Jae Cho, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT03044015: Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Official title: a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporotic Fractures
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2017-02-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.

AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.

METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.

DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.

ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.

Outcomes :

* new OF ratio in intervention vs control areas.
* maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
* assessment of cost-effectivity of the intervention


Eligibility criteria: Inclusion Criteria:

* Major OF (distal forearm, vertebral, hip, pelvis and humerus
* Caused by a low impact mechanism

Exclusion Criteria:

* High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
* Patients not residing in the area of the targeted primary care practices
* Patients with an invalidating disease (dementia ...)

Primary outcomes:
measure: Number of patients with osteoporotic fractures
timeFrame: 24 months
Secondary outcomes:
measure: economic cost
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
References:
Clinical trial NCT00564915: RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Official title: RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2007-11-29
Enrollment: 145
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week

Primary outcomes:
measure: Change in seizure frequency
timeFrame: 3 months
Secondary outcomes:
measure: Tolerability and assessment of ketosis and growth
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Child Health, The Wolfson Centre
Study officials:
affiliation: UCL Institute of Child Health
name: Helen Cross, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.
Clinical trial NCT02001415: Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia
Official title: Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Progressive Myopia
Keywords: Progressive Myopia
Contact Lenses
Spectacles
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, \& Myovision) on myopia control in Chinese adolescent patients.

Detailed description: Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia).

This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.

Eligibility criteria: Inclusion Criteria:

* Adolescent myopia patients
* Myopic refraction between -1.00D and -4.50D
* Astigmatism equal or less than -1.50D
* Normal break up time of tear film (BUT \> 10s)

Exclusion Criteria:

* Existence of any ocular diseases except ametropia
* Hyperopia
* Severe dry eye

Primary outcomes:
measure: Change of Ocular Axial Length
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change of Spherical Equivalent Refraction
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ophthalmology Department of Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Kai Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006415: Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)
Official title: Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Neurological Disorder
Conversion Disorder
Functional Neurological Disorders
Conversion Disorder With Weakness/Paralysis
Keywords: brain-computer interface
rehabilitation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder.


Eligibility criteria: Inclusion Criteria:

* DSM5 diagnosis of motor FND (limb weakness, gait disorder, tremor or dystonia) from a neurologist and/or neuropsychiatrist.
* Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale).
* Able to tolerate VR and BCI use.
* Age 18 - 60 years.
* English speaking.

Exclusion Criteria:

* Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting DSM-5 criteria) (Mini International Neuropsychiatric Interview \[MINI\] 7.0). Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
* Current diagnosis of epilepsy, autistic spectrum disorder, dementia, learning disability (defined as meeting DSM-5 criteria) based on clinical interview by a psychiatrist.
* A pacemaker, implantable cardioverter-defibrillator or any other implanted electronic or metallic device.
* Current pregnancy.
* Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
* Those enrolled in another clinical or research study.
* Those unable to give informed consent.

Primary outcomes:
measure: Change in sense of agency over limb movements
timeFrame: Baseline (same day as rehabilitation session 1, immediately before session) and after course of 10 sessions of brain-computer interface rehabilitation (same day as rehabilitation session 10, immediately after session) (intra-subject)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: