louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01522859: Telehealth Monitoring in Chronic Obstructive Pulmonary Disease
Official title: The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Telehealth
health related quality of life
Lead sponsor: South Eastern Health and Social Care Trust
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The the aim of this study is to determine the benefits of Telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major burden on healthcare systems worldwide. The current management of patients with COPD includes well established interventions such as pulmonary rehabilitation and inhaled therapies which have demonstrated variable impact on reducing rates of exacerbation and improving health related quality of life.

Telehealth is a home monitoring system used to record clinical observations and carry out question and answer sessions. It has been proposed that Telehealth medicine may offer an alternative strategy to the overall management of these patients.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)
* a minimum of two: Emergency Department admissions; hospital admissions or emergency GP contacts in the 12 months previous to the study

Exclusion Criteria:

* any respiratory disorder other than COPD
* patients cognitively unable to learn the process of monitoring

Primary outcomes:
measure: Change from baseline in St Georges's Respiratory Questionnaire at six months
timeFrame: Baseline and six months
Secondary outcomes:
measure: Change from baseline in EuroQol at six months
timeFrame: Baseline and six months
measure: Change from baseline in Hospital Anxiety and Depression Scale at six months
timeFrame: Baseline and six months
measure: healthcare utilisation
timeFrame: six months
measure: number of exacerbations
timeFrame: six months
measure: satisfaction
timeFrame: six months
measure: cost effectiveness
timeFrame: six months
Other outcomes:
Locations:
city: Lisburn
country: United Kingdom
facility: South Eastern Health and Social Care Trust
state: Co Antrim
Study officials:
affiliation: South Eastern Health and Social Care Trust
name: Janet E McDowell, BScHons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Eastern Health and Social Care Trust
name: Stephen Tate, BSc,MD,FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751359: Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
Official title: Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: INSYS Therapeutics Inc
First posted: 2016-04-26
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics.

Detailed description: This within-subject, double-blind, placebo-controlled study will assess the analgesic and subjective effects of a range of CBD doses (0, 200, 400, or 800 mg, po). Volunteers will participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics. The order of CBD dose will be randomized across participants. Secondary measures will include subjective and physiologic effects of CBD.

Eligibility criteria: Inclusion Criteria:

* Able to perform study procedures
* Women practicing an effective form of birth control

Exclusion Criteria:

* Female subjects who are currently pregnant or breastfeeding.
* Current illicit drug use
* Presence of significant medical illness
* History of heart disease
* Request for drug treatment
* Current parole or probation
* Recent history of significant violent behavior
* Major psychiatric disorder
* Current use of any prescription or over-the-counter medication
* Current pain
* Clinically significant Raynaud's syndrome

Primary outcomes:
measure: Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
timeFrame: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose
Secondary outcomes:
measure: Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
timeFrame: 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Cooper
state: New York
Study officials:
affiliation: New York State Psychiatric Institute / CUMC
name: Ziva D Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738659: Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
Official title: Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: sodium ,diuretics, PCWP
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: Ospedale G. F. Ingrassia
First posted: 2012-11-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.

Detailed description: the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.

Eligibility criteria: Inclusion Criteria:

* compensated HF patients

Exclusion Criteria:

* decompensated HF patients

Primary outcomes:
measure: number of hospital readmitted patients
timeFrame: 1 year
Secondary outcomes:
measure: number of death
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: G.F. Ingrassia Hospital
name: pietro di pasquale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01634659: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Official title: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lenses
myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 330
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: The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Sign written Informed Consent Document and HIPAA form.
* Be current weekly/monthly replacement contact lens wearer.
* Be willing to not sleep in contact lenses during the study period.
* Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
* Have best corrected visual acuity of at least 20/25 in each eye.
* Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Be a neophyte or current wearer of daily disposable lenses.
* Require monovision correction or use multifocal contact lenses.
* Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Have a history of ocular surgery/trauma within the last 6 months.
* Use topical ocular or systemic antibiotics within 7 days of enrollment.
* Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
* Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
* Use re-wetting drops once or more per day.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Comfort
timeFrame: Day 8
Secondary outcomes:
measure: Overall Quality of Vision
timeFrame: Day 8
measure: End of Day Comfort
timeFrame: Day 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, MBA, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004659: Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy Vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: adult brain tumor
brain tumor
childhood brain tumor
genetic condition
nervous tissue tumors
oncologic disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 2000-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function.

II. Examine survival, clinical outcome, and local tumor imaging response in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution.

Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment.

The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first.

Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Eligibility criteria: * Multiple newly diagnosed brain tumors
* Histologic confirmation of carcinoma at primary or metastatic site
* Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm
* No more than 4 tumors on magnetic resonance imaging
* Systemic disease controlled
* Neurologic function preserved
* Radiographic staging within 2 months of randomization required
* Performance status: Karnofsky 70%-100%

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Douglas Kondziolka
role: STUDY_CHAIR
References:
Clinical trial NCT04455659: Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Official title: Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pudendal Neuralgia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 52
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell exercise, relaxation exercise and underwater exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received only the traditional physical therapy exercise for the same period of time. Intensity of pain by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake are measured pre and post treatment.


Eligibility criteria: Inclusion Criteria:

* Male with ages ranged from 30 to 50 years.
* Suffering from pudendal neuralgia and its intractable perineal pain that persists for a minimum one month beyond the acute onset.
* Pelvic pain with sitting that relived by standing or toilet sitting.
* Anal pain, dyspareunia and genital pain

Exclusion Criteria:

* Those who had history of skin malignancy.
* Diabetic,
* Sensory disorders,
* Circulatory insufficiency
* Acute infection of the treatment area,
* Renal failure

Primary outcomes:
measure: Pain intensity (NRS)
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: Serum cortisol level
timeFrame: 8 weeks of treatment
measure: Calculation of Etodolac Intake (ELI) in mg
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT04063800: Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI
Official title: Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Adenocarcinoma
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 195
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients with high-risk prostate cancers who underwent pre-operative prostate MRI followed by radical prostatectomy +/- lymphadenectomy

Brief summary: With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).


Eligibility criteria: Inclusion Criteria:

* Age \> 18yo
* Patients underwent radical prostatectomy
* High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score \> 7)

Exclusion Criteria:

* No available pre-operative MRI
* No analyzable pre-operative MRI
* proof of lymph-node involvement (cN1/2 or pN1/2)
* post-operative PSA \> 0.04ng/mL

Primary outcomes:
measure: Prediction of biochemical failure
timeFrame: From the date of surgery until data collection (up to 100 months)
Secondary outcomes:
measure: Prediction of survival without biochemical failure
timeFrame: From the date of surgery until data collection (up to 100 months)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
state: Bretagne
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
state: Bretagne
Study officials:
References:
Clinical trial NCT05831800: Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
Official title: Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dehydration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm prospective feasibility study
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years

Exclusion Criteria:

* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives
* Non-intact skin such as skin breakdown where the device is to be placed (upper back)
* Implantable pulse generators such as pacemakers and defibrillators
* Any medical or psychiatric condition, which in the opinion of the investigator precludes participation

Primary outcomes:
measure: Mean use time of the wearable sensor
timeFrame: Up to 7 days
Secondary outcomes:
measure: The mean number of days the sensor provides valid measurements
timeFrame: Up to 7 days
measure: Mean and standard deviation of the device output variables
timeFrame: Up to 7 days
measure: Stability of device measurements following weekly patch replacement
timeFrame: Day 8, 15, 22, 29
measure: Clinical assessment of hydration status
timeFrame: Day 1, 8, 15, 22, 29
measure: User satisfaction
timeFrame: Day 8, 15, 22, 29
measure: Frequency and severity of adverse device effects
timeFrame: Day 1-30
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Tempe Helse- og velferdssenter
Study officials:
affiliation: Mode Sensors AS
name: Sigve N Aas, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05627700: AVL200 IOL for Treatment of Cataract and Presbyopia
Official title: A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Atia Vision
Sponsor class: INDUSTRY
First posted: 2022-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the performance of the AVL200 IOL in terms of visual function improvement over a range of focal points. Participants meeting eligibility criteria will undergo cataract surgery with implantation of the AVL200 intraocular lens (IOL), then be followed through 1 year postoperatively. Postoperative assessments include safety and visual function.


Eligibility criteria: Inclusion Criteria:

* Visually significant cataract
* Best corrected distance visual acuity between 20/40 and 20/200
* Potential distance visual acuity of 20/32 or better
* Corneal astigmatism ≤ 1.5 diopters

Exclusion Criteria:

* Use of medication that could affect accommodation
* Previous corneal surgery or significant corneal abnormalities
* Ocular pathology or degenerative disorder having potential to impair visual acuity
* Pupil abnormality
* Intraoperative cataract surgery complications that could affect IOL implantation or positioning

Primary outcomes:
measure: Change in monocular best corrected distance visual acuity
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Change in monocular distance-corrected near visual acuity
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Chennai
country: India
facility: Dr Agarwal's Eye Hospital
state: Tamal Nadu
Study officials:
affiliation: Dr. Agarwals Eye Hospital
name: Ashvin Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03460600: Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).
Official title: OCT Documents Vitreo-papillary Traction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tomography, Optical Coherence
Lead sponsor: Dr. S.S. Michel Clinic
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any himan subject that is found to have VPT by OCT.

Brief summary: Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously known.

Detailed description: In ophthalmology vitreo-macular adhesion, vitreo-macular traction and posterior vitreous detachment were recognized entities for a long time. On the other hand vitreo-papillary adhesion/ traction is a fairly new concept in ophthalmology that became known after the use of OCT in ophthalmology imaging. Reasons, effects and ways of treatment of vitreo-papillary traction will take some time to evolve. The case study in which this traction was documented was initiated by an observation of a persistent, tiny single retinal hemorrhage above the optic disc of an eye. The patient was completely asymptomatic because of the vitreo-papillary traction but the OCT documentation of the case was so clear and striking.

Eligibility criteria: Inclusion Criteria:

* any human subject that is found to have VPT by OCT.

Exclusion Criteria:

-

Primary outcomes:
measure: Tomography, Optical Coherence (OCT)
timeFrame: through study completion, usually one day.
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dr. S.S. Michel Clinic
state: Alberta
Study officials:
affiliation: Dr. S.S. Michel Clinic Edmonton, Alberta Canada
name: shawkat michel
role: PRINCIPAL_INVESTIGATOR
References: