louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04587349: Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
Official title: Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: balance
movement
exergaming
posture
quality of life
gait
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 2
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy. High intensity motion improves engine function and quality of life in a neurologist. With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants. The investigaters randomly select participants who only perform the rehabilitation treatment have performed. The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment. The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients. (6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke. Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test). Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography. The results are compared and evaluated among the groups. The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity. Patients were followed for 2 years and participated in a follow-up study every six months.


Eligibility criteria: Inclusion Criteria:

• post stroke

Exclusion Criteria:

* Sever heart problem
* sever demeanor
* alcoholism
* drug problems

Primary outcomes:
measure: gait / functional test
timeFrame: 2 years, m (higher point is better)
measure: balance test
timeFrame: 2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
measure: postrural control test
timeFrame: 2 years, mm (2 year-long, the smaller the mm the better the result)
measure: Quality of life measured by EQ5-D scale
timeFrame: 2 years, 0-5 scale (2 year-long, higher point is better)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Dr. József Tollár
state: Somogy
Study officials:
References:
Clinical trial NCT01664949: A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 460
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 a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Have used artificial tears for dry eye

Exclusion Criteria:

* Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
* History of eye surgery or trauma in the 6 months prior to study start
* Current use or use within 2 weeks of study start, of topical eye medications.

Primary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Change From Baseline in Tear Break-up Time (TBUT)
timeFrame: Baseline, Day 90
measure: Change From Baseline in Corneal Staining
timeFrame: Baseline, Day 90
measure: Change From Baseline in Conjunctival Staining
timeFrame: Baseline, Day 90
measure: Change From Baseline in the Schirmer Test
timeFrame: Baseline, Day 90
Other outcomes:
Locations:
city: Randwick
country: Australia
state: New South Wales
city: Leuven
country: Belgium
city: Marseille
country: France
city: Tours Cedex
country: France
city: Freiburg
country: Germany
city: Padova
country: Italy
city: Parma
country: Italy
city: Moscow
country: Russian Federation
city: Huelva
country: Spain
city: Valencia
country: Spain
city: Southampton
country: United Kingdom
state: Hampshire
city: Great Yarmouth
country: United Kingdom
state: Norfolk
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01039649: A Study to Test Lung Function After Radiation Therapy
Official title: Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Neoplasm Metastasis
Keywords: radiation
Tomography, Spiral Computed
Four-Dimensional Computed Tomography
Respiratory Function Tests
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with lung disease requiring radiation therapy. Lung tumor may be lung cancer or metastasis to the lung. Radiation simulation method must be four-dimensional computer tomography (4D-CT)

Brief summary: It is known that radiation damages lung tissue. New human studies at University of Iowa show that the radiation damage is not as expected. The purpose of this study is to document lung function using four-dimensional computed tomography (CT) and quantify changes three months after radiation therapy for malignant lung disease.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of small cell or non-small cell lung cancer or metastatic tumor to the lung being scheduled for localized radiation therapy (including radiosurgery)
* No prior or future planned surgery for the treatment of the lung cancer.
* Age ≥ 18 years
* Karnofsky 60%
* Not pregnant.
* Ability to understand and the willingness to sign a written informed consent document
* Ability and willingness to participate in breathing training and compliance wiht breathing apparatus so that radiation doses are optimally linked to 4D-CT images
* Ability to tolerate CT contrast

Exclusion Criteria:

* No prior thoracic radiotherapy will be permitted
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women
* Severe COPD that requires chronic prednisone or multiple inhalers
* Underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
* Oxygen dependence at baseline
* Recent lung surgery or abdominal surgery (within 3 weeks) that would compromise respiratory pattern.

Primary outcomes:
measure: Spirometry correlated to lung expansion maps
timeFrame: 3 months post radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Department of Radiation Oncology
state: Iowa
Study officials:
affiliation: University of Iowa
name: John Bayouth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Johm M. Buatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04461249: Comparison Between Latanoprost , Travoprost and Tafluprost in Reducing IOP Fluctuation in POAG Patients
Official title: Comparison Between the Effect of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Keywords: Prostaglandin analogues
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed primary open-angle glaucoma patients presented to the Glaucoma outpatient clinic, Kasr El-Aini hospital, Cairo University.

Brief summary: Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and tolerable.


Eligibility criteria: Inclusion Criteria:

* Both genders aged 18 years or more.
* Newly diagnosed POAG cases having :

IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional damage (confirmed with OCT and visual field)

Exclusion Criteria:

* Angle closure glaucoma.
* Secondary glaucomas.
* Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target IOP.
* History of ocular trauma, laser or intraocular surgery.
* Any other ocular disorder including uveitis and cystoid macular edema.
* Known history of allergy or sensitivity to any components of the study medications.

Primary outcomes:
measure: To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
timeFrame: 3 months from starting the treatment
Secondary outcomes:
measure: To Compare Between the 3 drugs regarding their tolerability and assess their side effects.
timeFrame: 3 Months from starting the treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El-Aini hospital
Study officials:
References:
citation: El Hajj Moussa WG, Farhat RG, Nehme JC, Sahyoun MA, Schakal AR, Jalkh AE, Abi Karam MP, Azar GG. Comparison of Efficacy and Ocular Surface Disease Index Score between Bimatoprost, Latanoprost, Travoprost, and Tafluprost in Glaucoma Patients. J Ophthalmol. 2018 Mar 7;2018:1319628. doi: 10.1155/2018/1319628. eCollection 2018.
Clinical trial NCT05220449: Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery
Official title: Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Visual Impairment
Stroke
Parkinson Disease
Keywords: Stroke
Visual field
Oscillations
tACS
Parkinson's Disease
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 30
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: This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.


Eligibility criteria: Inclusion Criteria:

1. the patient can consent for themselves;
2. age 18+ years old;
3. at least 7 days since diagnosis "stroke".
4. Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field

Exclusion Criteria:

1. Diminished capacity to consent;
2. Pregnancy
3. Known or suspected non-compliance, drug or alcohol abuse
4. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
5. Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.
6. Previous enrolment into the current study
7. Exclusion criteria of MRI, tACS, TMS
8. Use of psychoactive medication

Primary outcomes:
measure: Changes in visual field functions
timeFrame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary outcomes:
measure: Changes in motion discrimination and integration performances
timeFrame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
measure: Changes in inter-areal cross-frequency interaction
timeFrame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
measure: Changes in visual tracts integrity
timeFrame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
measure: Changes in functional connectivity within the broad visual network
timeFrame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Campus Biotech, EPFL
Study officials:
References:
Clinical trial NCT06264349: Women and Maternity: Development of a Nutritional Education Project
Official title: Women and Maternity: Development of a Nutritional Education Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Lactation
Keywords: Lifestyle
Health
First one-thousand days
Dietary habits
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental - controlled, non-randomized pilot study
Primary purpose: PREVENTION

Brief summary: The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.

Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* first trimester;
* parents' ability to speak and understand the Italian language;
* parents' ability to sign the informed consent and to fill in the questionnaires

Exclusion criteria:

* age \< 18 years;
* diagnosis of chronic and/or eating disorders

Primary outcomes:
measure: Gestational weight gain management
timeFrame: GWG will be evaluated at T2 (1 month after delivery)
Secondary outcomes:
measure: Nutritional aspects evaluation during pregnancy and lactation
timeFrame: Nutritional aspects will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
measure: Physical activity evaluation during pregnancy and lactation
timeFrame: Physical activity will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
measure: Smoking habits during pregnancy and lactation
timeFrame: Smoking habits will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
measure: Maternal attitude towards infant feeding.
timeFrame: Maternal attitude towards infant feeding will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T2, 4 weeks after the delivery).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03837249: Self-Management of Sleep Among Older Adults
Official title: Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sleep Disturbance
Keywords: Older People
Sleep Disturbance
Self-Monitoring
Self-Management
Social Support
Wrist-worn Actigraphy
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative control - 3 group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.


Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Self-report difficulty sleeping
* Willingness to wear the PSMD for four weeks
* Cognitive abilities (Mini Cog of 5 or above).

Exclusion Criteria:

* Under the age of 65
* Presence of known sleep disorders
* Severe cognitive or neurosensory impairment

Primary outcomes:
measure: Use of A Personal Sleep Monitoring Device (PSMD)
timeFrame: up to 4 weeks
measure: Changes in Sleep
timeFrame: Week 1 and Week 4
measure: Changes in Health
timeFrame: Week 1 and Week 4
Secondary outcomes:
measure: Usability of PSMD
timeFrame: Week 2 and 4
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Raeann G LeBlanc, PhD, DNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718249: Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Official title: Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Keywords: Deep Brain Stimulation (DBS)
Post-coma
Consciousness
Vegetative state
Minimally conscious state
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
name: Medtronic
First posted: 2012-10-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

Detailed description: Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).

Eligibility criteria: Inclusion Criteria:

* Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.

Exclusion Criteria:

* Cerebral death, Locked-In Syndrome, blindness, deafness

Primary outcomes:
measure: CRS-R scores (Coma Recovery Scale-Revised)
timeFrame: after 2 months and after 7 months
Secondary outcomes:
measure: signs of awakening at night
timeFrame: during the 10 months of the study
measure: zerit burden interview
timeFrame: at 1 month and at 10 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Jacques LEMAIRE
role: PRINCIPAL_INVESTIGATOR
References: