louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02882893: Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines
Official title: Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines: Active Controlled, Double-blind, Randomized, Multi-center, Phase II/III Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Crows Feet Lines
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 238
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 purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).


Eligibility criteria: Inclusion Criteria:

* Male or female of at least 18 to 75 years old
* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Primary outcomes:
measure: Facial Wrinkle Scale(FWS) severity of Crow's feet lines(CFL) at maximum smile as assessed by investigators
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT00665093: Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 1569
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and Type 2 diabetes mellitus

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Levemir® above 6 yrs
* NovoMix® 30 above 18 yrs
* Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria:

* Current treatment with NovoMix® 30 or Levemir®

Primary outcomes:
measure: HbA1c
timeFrame: at 24 weeks
Secondary outcomes:
measure: FPG, PG profile, weight, % of subjects on target
timeFrame: at 24 weeks
Other outcomes:
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Milenkovic T. Significant Improvements in Glycemic Control with BIAsp 30 in Clinical Reality: Experience from clinical practice in Macedonia. ADA American Diabetes Association 2009; Country: USA City: New Orleans
Clinical trial NCT00260793: Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Official title: Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Ropinirole
Parkinson's disease
dopamine agonist
Lead sponsor: Colorado Neurology
Sponsor class: OTHER
Collaborators: name: Colorado Neurology
name: GlaxoSmithKline
First posted: 2005-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.


Eligibility criteria: Inclusion Criteria:

* Patients must give written informed consent prior to any specific study procedures.
* Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
* Age greater than or equal to 25 years.
* Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
* Stable dose of all medications for 4 weeks.

Exclusion Criteria:

* Current hallucinations.
* History of disabling hallucinations or hallucinations in past requiring treatment.
* Troublesome edema (swelling).
* Unstable depression.
* Female who is pregnant or lactating.
* Use of an investigational drug with in the last 30 days.
* Other inclusion or exclusion criteria to be evaluated by the physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Colorado Neurology, P.C.
state: Colorado
Study officials:
affiliation: Colorado Neurology, P.C.
name: Pinky Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203593: Exercise and Prevention of Syncope: EXPOSE
Official title: EXercise for the Prevention of Syncope Evaluation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Syncope
Keywords: exercise
total peripheral resistance
venoconstriction
blood volume expansion
orthostatic tolerance
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether eight weeks of exercise performed at an intensity of approximately 65% VO2max will improve symptoms associated with fainting (vasovagal syncope).

Detailed description: Background: Vasovagal syncope affects 20-30% of the population, and for those who faint recurrently it causes a significant reduction in the quality of life. Although significant progress has been made in the past 15 years in our understanding of its diagnosis and prognosis, our therapeutic attempts often end in failure. Many patients who have been diagnosed with vasovagal syncope have a reduced orthostatic tolerance. Improved orthostatic tolerance has been achieved through exercise in a number of studies on healthy individuals. However, its efficacy as a means of treatment for those with vasovagal syncope has not been thoroughly explored.

Comparison: Subjects will be randomized to one of two groups: an exercise group or control. The exercise group will be asked to train at a target of approximately 65% of their maximum exercise capacity (VO2max) for 8 weeks/3 times per week. The control group will be asked to perform a series of neck rotation exercises. Orthostatic tolerance will be examined in both groups pre and post intervention.

Eligibility criteria: Inclusion Criteria: a diagnosis of vasovagal syncope as the cause of loss of consciousness, \>1 lifetime syncope spell preceding enrolment, \>-3 points on the S3 score for structurally normal hearts, \>18 yrs of age with informed consent -

Exclusion Criteria: subjects with a negative Physical Activity Readiness Questionnaire (PARQ), those who are unable to provide informed consent, those with a VO2max \>55ml/kg/min, those who exercise more than 30 minutes per day, 3 times per week, other causes of syncope, individuals with valvular, coronary, myocardial, or conductive abnormality, significant arrhythmia, hypertrophic cardiomyopathy, permanent pacemaker, seizure disorder, heart failure, major chronic cardiovascular disease, or renal dysfunction.

-

Primary outcomes:
measure: Orthostatic tolerance - this will be measured at baseline and post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary (Health Sciences Center)
state: Alberta
Study officials:
affiliation: University of Calgary
name: Robert S Sheldon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596593: Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors
Official title: Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Keywords: Solid tumor
China
MSI
ctDNA
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 8000
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 molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.

Detailed description: This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).

Eligibility criteria: Inclusion Criteria:

1. Male or female, age≥18 years old.
2. Confirmed malignant solid tumor by histopathology or cytopathology.
3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
4. Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
5. Signed the informed consent with name and time.

Exclusion Criteria:

1. Hematological malignancy
2. Patients who received immuotherapies.
3. Patients who received blood transfusion within one month before blood collection.
4. Pregnancy.

Primary outcomes:
measure: Incidence of MSI-H across different cancer types in Chinese patients
timeFrame: Two years
Secondary outcomes:
measure: Incidence of Lynch syndrome across different cancer types
timeFrame: Two years
measure: Concordance between blood-MSI and corresponding tissue-MSI status
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University
name: Shen Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.
Clinical trial NCT04661293: Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
Official title: Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2020-12-10
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to autologous muscle derived cells (AMDCs). Treating physicians may submit requests for expanded access to Cook MyoSite's investigational product by email to MYO-ExpandedAccess@CookMyoSite.com.

Detailed description: Cook MyoSite, Inc. (Cook MyoSite) is committed to conducting rigorous, controlled clinical trials with variable inclusion and exclusion criteria based upon the indicated use under investigation. Participation in our clinical trials is the first and most preferable route to access our investigational product.

We understand that there may be patients with a serious, life-threatening disease or condition that have explored all other treatment options and are unable or ineligible to participate in our clinical trials. Expanded access, otherwise known as "compassionate use" or "pre-approval access," is a potential pathway to access an investigational product that a patient may otherwise be unable to receive.

Cook MyoSite will consider providing an investigational product to a qualified requesting physician currently licensed within the United States via the United States Food and Drug Administration's (FDA's) expanded access pathway outside of an active clinical trial when eligibility criteria are met.

Eligibility criteria: Eligibility Criteria:

1. The patient has a serious or life-threatening disease or condition with no satisfactory alternative.
2. Positive assessment that the anticipated benefits outweigh the risks to the patient.
3. Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product.
4. A determination that expanded access will not interfere with Cook MyoSite's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.
5. The patient can undergo a muscle biopsy procedure(s).
6. The patient can undergo Cook MyoSite's required donor screening and testing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Cook MyoSite, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02031393: Establishing First Trimester Markers for the Identification of High Risk Twin
Official title: Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small for Gestational Age (Disorder)
Pre-Eclampsia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig

Brief summary: The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.


Eligibility criteria: Inclusion Criteria:

* pregnant women from 11 -14 weeks of gestation

Exclusion Criteria:

* nuchal thickness above 3 mm,
* Chronic hypertension,
* thrombophilia,
* Diabetes

Primary outcomes:
measure: The development of preeclampsia
timeFrame: after delivery
Secondary outcomes:
measure: intra uterine growth restriction
timeFrame: after delivery
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofe obstetric department
state: Zrifin
Study officials:
References:
Clinical trial NCT03670511: Validation and Predictive Equation for Sit-to-stand Test in Children
Official title: Validation and Predictive Equation for Sit-to-stand Test in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 397
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.


Eligibility criteria: Inclusion Criteria:

* participation in the national physical education program at school
* free of physical activity during one hour preceding the experiments

Exclusion Criteria:

* diagnosis of chronic lung, cardiac or neuromuscular disease
* BMI higher than 85th percentile for children of the same age and sex
* a motor disability based on parents' answer to standardized questions.

Primary outcomes:
measure: number of sit-to-stand
timeFrame: 1 minute
Secondary outcomes:
measure: pulsed oxygen saturation
timeFrame: 1 minute
measure: heart rate
timeFrame: 1 minute
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT03877211: Channel Interaction in Cochlear Implant and Speech Understanding in Noise
Official title: Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implants
Keywords: speech audiometry
psychophysical tuning curve
electrophysiology
auditory brainstem response
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.


Eligibility criteria: Inclusion Criteria:

* Fluent in French
* Able to understand written instructions
* Under French public medical insurance

  * Normal-hearing subjects only:

    * Adult between 18 and 50 years old
    * Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
    * Clear auditory canal and normal eardrum;
    * Average audiometric loss under 20 decibels Hearing Level (dB HL)
  * Cochlear implant users only:

    * Adult between 18 and 60 yo
    * Normal middle ear
    * Used the cochlear implant for more than a year
    * Wearing a device from the company Neurelec/Oticon Medical

Exclusion Criteria:

* Behavioral and/or neurological disorders
* Proven psychological disorder
* Use of psychotropic medication
* People who experience migraine attacks on a regular basis
* Use of ototoxic medication
* Exposed to loud noises within the last 72 hours
* Included in another clinical trial that uses medication

Primary outcomes:
measure: Percentage of syllable correctly recognized during speech audiometry test
timeFrame: At inclusion
Secondary outcomes:
measure: Sound masking threshold
timeFrame: At inclusion
measure: Electrically-evoked Auditory Brainstem Response (eABR)
timeFrame: Up to 12 months after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00423111: Correlation Between Cognitive Functions and MRI in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Memory
Cognitive deficits
MRI
Hippocampus
Prefrontal cortex
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients.

Detailed description: Recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. The origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. EDSS). The research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex.

To test this hypothesis, we plan to perform volumetric measurements of such regions on MRI scans obtained from MS patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of MRI scanning.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis
* Age 18-65

Exclusion Criteria:

* Another brain disease
* Stroke
* Brain trauma
* Neurosurgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Anat Achiron, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
References: