louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00168324: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 599
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: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with macular edema resulting from retinal vein occlusion
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin

Primary outcomes:
measure: Cumulative Response Rate of 15 or More Letter Improvement
timeFrame: Up to 180 Days
Secondary outcomes:
measure: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Day 90, Day 180
measure: Change From Baseline in Retinal Thickness in the Study Eye
timeFrame: Baseline, Day 90, Day 180
measure: Percentage of Patients With a Change From Baseline in BCVA by Category
timeFrame: Baseline, Day 90
measure: Percentage of Patients With a Change From Baseline in BCVA by Category
timeFrame: Baseline, Day 180
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Sydney
country: Australia
city: Graz
country: Austria
city: Halifax
country: Canada
state: Nova Scotia
city: Brno
country: Czechia
city: Creteil
country: France
city: Karlsruhe
country: Germany
city: Rehovot
country: Israel
city: Tabacalera
country: Mexico
city: Makati
country: Philippines
city: Coimbra
country: Portugal
city: Arcadia
country: South Africa
city: Kaohsiung
country: Taiwan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
Clinical trial NCT04993196: Quantitative T1rho Magnetic Resonance Imaging in Healthy Subjects
Official title: Quantitative T1rho Magnetic Resonance Imaging in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 30
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: T1rho imaging is a new MRI technique that has strong potential in neuroimaging. This technique does not require exogenous contrast agents and has high spatial resolution.

In this study we aim to characterise the normal appearance of T1rho in the brain parenchyma in healthy participants. T1rho values will be measured in normal brain structures.


Eligibility criteria: Inclusion Criteria:

- Male and female volunteers greater than or equal to 18 years of age

Exclusion Criteria:

* Subjects with a contraindication to magnetic resonance imaging such as the presence of metallic implants, claustrophobia and pregnancy.
* Subjects with previous severe allergic or anaphylactoid reaction to a gadolinium contrast agent, or contraindication to contrast gadolinium administration, such severe renal disease or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis
* Subjects who are unable to tolerate the scan without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.

Primary outcomes:
measure: T1rho value in normal grey and white matter in healthy volunteers
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK
Study officials:
References:
Clinical trial NCT00005096: Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Official title: Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rhone-Poulenc Rorer
First posted: 2004-03-04
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

Detailed description: OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Eligibility criteria: Eligibility Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Potential candidate for radical prostatectomy
* Any of the following:

  * Clinical stage T3 patients
  * Serum PSA at least 20 ng/mL
  * Gleason score 8-10
  * Clinical T2 disease and either of the following:

    * MRI evidence of seminal vesicle involvement
    * Gleason 4+3 cancer with either 5 or 6 biopsies positive
* CALGB 0-1
* WBC greater than 3,000/mm3
* Hematocrit greater than 30%
* Platelet count greater than 100,000/mm3
* SGOT, total bilirubin within normal limits
* Signed Informed consent

Exclusion Criteria:

* No prior hormones, radiation or chemotherapy for prostate cancer
* Evidence of serious active infection

Primary outcomes:
measure: Complete Response Rate
timeFrame: 2 Months, 6 Months
Secondary outcomes:
measure: Percentage of Participants with mild to moderate toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary-Ellen Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260696: Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender
Official title: Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults recruited to complete self-administered online service

Brief summary: The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life.


Eligibility criteria: Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Not currently pregnant
4. Does not participate in intense fitness or body building program
5. Weight loss not through illness or injury
6. Lives in South Korea, Australia, or India
7. BMI above or equal to 18 and associated weight class (Normal Weight or above) will be determined by a programmed calculation based on participant-reported height and weight.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria.

Primary outcomes:
measure: Score on IWQOL-Lite validated
timeFrame: At time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02109796: Effects of tDCS on Quadriceps Strength After Stroke
Official title: a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: tDCS
Stroke
Force
Spasticity
Gait
EMG
Isokinetic
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2014-04-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.


Eligibility criteria: Inclusion Criteria:

* written consent
* hemiparetic patient after stroke in chronic phase (\> 6 months)
* capacity to walk with or without technical assistance
* following rehabilitation program for lower limbs

Exclusion Criteria:

* patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
* previous orthopedic surgery in paretic lower limb (\<6 moths)
* usual tDCS contraindications
* pregnant woman

Primary outcomes:
measure: maximum voluntary isometric strength of knee extensors
timeFrame: 2 hours
Secondary outcomes:
measure: Resistive peak torque during passive knee flexion
timeFrame: 2h
measure: Angle related to the resistive peak torque generation of the knee extensors
timeFrame: 2h
measure: Amplitude of the interpolation twitch
timeFrame: 2h
measure: EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
timeFrame: 2h
measure: Functional evaluation of the gait performance and balance
timeFrame: 2h
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincare Hospital
Study officials:
affiliation: Raymond Poincaré Hospital
name: Roche Nicolas, MD PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Raymond Poincare Hospital
name: Bensmail Djamel, MD PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Clinical trial NCT02671396: Effects of Virtual Reality Based Training on Posture Stability in Parkinson's Disease
Official title: Effects of Virtual Reality Based Training on Posture Stability in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Virtual Reality
Postural Stability
Balance Training
Parkinson's Disease
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is to examine the effects of a virtual reality based balance training using the Kinect sensor on postural stability and functional balance in individuals with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Hoehn and Yahr stages I through III
* A score of more than or equal to 24 on the mini-mental state examination
* Stable medication usage
* Freedom from any other problems that might affect training

Exclusion Criteria:

* Unstable medical conditions
* Histories of other diseases known to interfere with participation in the study

Primary outcomes:
measure: Limits of stability test
timeFrame: Change from Baseline at 8 weeks
measure: One-leg stance test
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Change from Baseline at 8 weeks
measure: Timed up and go test
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Shih MC, Wang RY, Cheng SJ, Yang YR. Effects of a balance-based exergaming intervention using the Kinect sensor on posture stability in individuals with Parkinson's disease: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2016 Aug 27;13(1):78. doi: 10.1186/s12984-016-0185-y.
Clinical trial NCT01958996: Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: High Grade Lymphomas CD20 Positive
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's lymphoma. In order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial.

Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. The estimated two-years overall survival was 74%. The main haematological toxicity was neutropenia.

This study is still ongoing to confirm recommended dose of oral anthracycline.


Eligibility criteria: Inclusion Criteria:

* CD20-positive diffuse large B-cell lymphoma.WHO classification (55)
* Written informed consent
* Age \> 65 and \< 80 years
* Performance status (ECOG) \<3
* measurable disease
* Serology HIV negative, Hepatites B, Hepatites C negative

Exclusion Criteria:

* Serology HIV positive, Hepatite B positive, Hepatite C positive
* Cardiac failure.

Primary outcomes:
measure: Maximum tolerated dose of idarubicin
timeFrame: 9 months
Secondary outcomes:
measure: Remission rate after 4 cycles and 8 cycles
timeFrame: 9 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
citation: Guidez S, Lacotte-Thierry L, Tomowiak C, Princet I, Dreyfus B, Olivier G, Fleck E, Corby A, Motard C, Barrier J, Machet A, Le Du K, Debiais-Delpech C, Chabin M, Leleu X, Guilhot J, Delwail V. Oral CHOP-like chemotherapy in 60-80 years-old patients with diffuse large B-cell lymphoma. Br J Haematol. 2019 Sep;186(6):e175-e178. doi: 10.1111/bjh.16056. Epub 2019 Jul 15. No abstract available.
Clinical trial NCT04404296: Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter
Official title: Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitrectomy
Retinal Detachment
Vitreous Hemorrhage
Macular Holes
Epiretinal Membrane
Dislocated Intraocular Lens Into Vitreous
Retained Lens Fragments
Keywords: Small gauge vitrectomy probe
20000 cut per minute
Microincisional vitrectomy system
Lead sponsor: Peregrine Eye and Laser Institute
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional case series
Primary purpose: TREATMENT

Brief summary: Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases

Detailed description: We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.

Eligibility criteria: Inclusion Criteria:

* All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.

Exclusion Criteria:

* History of prior PPV, glaucoma, scleral thinning, and active or recent history of (\<3 months) ocular or extra-ocular infection

Primary outcomes:
measure: Operative time: Total
timeFrame: 6 months
Secondary outcomes:
measure: Pain scoring
timeFrame: 6 months
measure: Adverse events
timeFrame: Up to 3 months after surgery
measure: Number of times ancillary instruments placed in eye
timeFrame: 6 months
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Instittute
state: MM
Study officials:
affiliation: Peregrine Eye and Laser Institute
name: Harvey S Uy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03919396: Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
Official title: Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Orthokeratology
Keywords: Myopia
Myopia Control
Orthokeratology
Electroretinogram
Multifocal Electroretinogram
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: SEED Co. Ltd.
First posted: 2019-04-18
Enrollment: 91
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.

Detailed description: Myopia is the most common refractive error in the world. In Hong Kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. Orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material.

A recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.

Eligibility criteria: Inclusion Criteria:

* Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
* Best corrected Visual acuity: monocular ETDRS 0.1 or better

Exclusion Criteria:

* Ocular abnormality
* Contra-indicated for overnight orthokeratology lens wear
* History of refractive surgery
* Systemic diseases
* History of orthokeratology lenses wearing or other myopia control methods

Primary outcomes:
measure: Subjective Refraction
timeFrame: up to 24 months
Secondary outcomes:
measure: Axial Length
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Optometry, Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Henry HL Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: