louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03396783: Characterization of the Immunological Profile Patients With Post-polio Syndrome
Official title: Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poliomyelitis Sequelae
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.


Eligibility criteria: Inclusion Criteria:

Subjects with Post-polio Syndrome :

* age ≥ 18 years
* meeting the definition of the SPP according to the criteria of Halstead et al. (1995)

Controlled subjects :

* age ≥ 18 years
* matched on sex and age (+/- 5 years) with subjects with PPS

Exclusion Criteria:

* intercurrent neurological pathology,
* uncontrolled cardiovascular risk factors
* pulmonary comorbidity
* endocrine disorders
* systemic inflammatory pathology, autoimmune disease, dry syndrome,
* renal failure
* anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
* patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants

Primary outcomes:
measure: cytokines blood concentrations
timeFrame: blood sample during inclusion visit
measure: lymphocytes blood concentrations
timeFrame: blood sample during inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Lapeyronie
state: Herault
Study officials:
affiliation: UH Montpellier
name: Isabelle LAFFONT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02749383: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis
Official title: A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seborrheic Dermatitis
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 19 and 65 years old
* Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
* IGE (Investigator's Global Evaluation) Score 2 or 3

Exclusion Criteria:

* Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
* Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
* Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
* Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
* Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
* Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study

Primary outcomes:
measure: Treatment success rate in IGE(Investigator's Global Evaluation)
timeFrame: Change from Baseline at Day 14 and Day 28
Secondary outcomes:
measure: Change in Erythema severity score
timeFrame: Change from baseline at Day 14 and 28
measure: Change in Scale severity score
timeFrame: Baseline, Day 14 and Day 28
measure: Change in Visual Analogue Scale(VAS) score
timeFrame: Change from baseline at Day 14 and 28
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology, Chungang University Hospital
name: BeomJoon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06553183: Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients
Official title: Immersive Virtual Reality Based Exersice and Shoulder Proprioception and Range of Motion in Post-mastectomy Lymphedema Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphedema Arm
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients.

Detailed description: RESEARCH QUESTION:

Does Immersive virtual reality based exercise effective in improving shoulder proprioception and ROM for post-mastectomy patients?

Assessment:

The digital goniometer will be used in measuring shoulder extension, flexion, adduction, abduction, internal rotation and external rotation before the sessions and after one month of sessions. Also, shoulder proprioception will be assessed by the digital goniometer.The measurement will be taken for both the edematous side and the non-affected side.

Treatment:

Study group: the patients will receive eight sessions of Immersive virtual reality based exercise, 2 sessions per week for 4 weeks besides the traditional physical therapy.

Control group: the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* All the patients will be females.
* Patients with lymph node dissection.
* start at least 2 weeks after operation.

Exclusion Criteria:

* Vision problems.
* Medically instable patients.
* Balance disorders.
* Other musculoskeletal condition of shoulders.

Primary outcomes:
measure: shoulder proprioception
timeFrame: 4 weeks
Secondary outcomes:
measure: shoulder ROM
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05379283: Does Topical Lidocaine Decrease Sweat During Exercise in the Heat?
Official title: Does Topical Lidocaine Decrease Sweat During Exercise in the Heat?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sweat Pore Closure
Keywords: thermoregulation, sweating, exercise
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms. One arm will be pretreated with topical lidocaine, and the other will act as the control.

Detailed description: Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms. One arm will be pretreated with topical lidocaine, and the other will act as the control. Sweat will be collected via macroducts attached to each arm. Sweat production on each arm will be compared using t-tests.

Eligibility criteria: Inclusion Criteria: 18-35 years of age -

Exclusion Criteria: pregnant females

-

Primary outcomes:
measure: volume of sweat produced during exercise following topical lidocaine
timeFrame: one hour of exercise
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Michael J Buono
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911883: Evaluation of the Repeatability and Reproducibility of AngioVue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal, Glaucoma & Retinal Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.


Eligibility criteria: Inclusion Criteria:

1. Normal

   * Age \> 18.
   * No retinal pathology or glaucoma.
2. Glaucoma patient

   * Age \> 18.
   * Have glaucoma.
3. Retina patient

   * Age \> 18.
   * Have retina pathology.

Exclusion Criteria:

1. Normal

   * Unable to complete required exams.
   * Poor quality image data.
2. Glaucoma patient

   * Unable to complete required exams.
   * Poor quality image data.
   * Retinal pathology.
3. Retina patient

   * Unable to complete required exams.
   * Poor quality image data.
   * Glaucoma.

Primary outcomes:
measure: Retina vasculature
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01496183: Metabolic Effects of Olanzapine in Healthy Males
Official title: Metabolic Effects of Olanzapine in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer
* Male
* Aged 18-35 years
* Body Mass Index (BMI): \<30 kg/m2

Exclusion Criteria:

* Presence of any medical disorder that may confound the assessment of relevant biological measures

Primary outcomes:
measure: Change From Baseline in Weight
timeFrame: Assessed at baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Body Composition
timeFrame: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline in 24-Hour Dietary Recall
timeFrame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline in Resting Metabolic Rate
timeFrame: baseline and 2weeks of treatment
measure: Change From Baseline Triglycerides
timeFrame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline in Glucose
timeFrame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline in Leptin
timeFrame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline in Insulin
timeFrame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
measure: Change From Baseline Total Cholesterol
timeFrame: baseline and 2 weeks treatment
measure: LDL
timeFrame: baseline and 2 weeks treatment
measure: HDL
timeFrame: baseline and 2 weeks treatment
measure: Physical Activity as Measured Using a Physical Activity Monitor
timeFrame: baseline and 2 week treatment
Other outcomes:
measure: Laboratory Breakfast Intake
timeFrame: baseline and 2 week treatment
Locations:
city: Buffalo
country: United States
facility: Department of Psychiatry, The State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Steven L Dubovsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411383: Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
Official title: Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Airway Disease
Keywords: Diaphragm pacing
Respiratory assistance
Lung transplant
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.

Detailed description: This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing:

* the immediate safety and technical surgical results of implantation
* the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital
* the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)

Eligibility criteria: Inclusion Criteria:

* Patient is undergoing bilateral lung transplantation
* Signed written informed consent has been obtained prior to any study related procedure

Exclusion Criteria:

* Diaphragm malformation which makes the electrode insertion impossible
* Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
* Participation in other clinical studies that could interfere with the results in the ongoing study

Primary outcomes:
measure: Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
timeFrame: 30 days
measure: Tolerability: Patient withdrawal from treatment.
timeFrame: 30 days
measure: Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
timeFrame: 30 days
Secondary outcomes:
measure: Composite endpoint
timeFrame: 30 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Dries Testelmans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567983: Topical Cyclosporine and Disease Progression
Official title: Topical Cyclosporine and Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disease Progression
Disease Severity
Staining
Schirmers
OSDI
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.


Eligibility criteria: Inclusion Criteria:

* Mild to Moderate dry eye symptoms

Exclusion Criteria:

* Current use of Restasis

Primary outcomes:
measure: Disease Severity
timeFrame: 1 yr
Secondary outcomes:
measure: Staining
timeFrame: 1 yr
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lakeside Eye Clinic
state: Illinois
Study officials:
affiliation: Lakeside Eye Clinic
name: Sanjay Rao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797783: Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
Official title: Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Ametropia
Presbyopia
Refractive Error
Keywords: Myopia
Presbyopia
Refractive error
Contact lenses
Multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 83
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 was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent Document.
* Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
* Currently wear soft contact lenses.
* Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
* Manifest cylinder less than or equal to 1.00 D.
* Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
* Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
* History of corneal or refractive surgery.
* Biomicroscopy findings greater than Grade 2 at baseline.
* A pathologically dry eye that precludes contact lens wear.
* Monocular (only one eye with functional vision).
* Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
* History of intolerance or hypersensitivity to any component of the investigational products.
* Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
* Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective Overall Vision
timeFrame: Up to Day 30
Secondary outcomes:
measure: Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
timeFrame: Up to Day 30
measure: Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
timeFrame: Up to Day 30
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Justin Webb, O.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855761: Testing a Novel Community-based Occupational Therapy Model
Official title: Improving Equitable Care With Narrative Medicine and a Novel Community-based Occupational Therapy Care Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders, Severe
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eskenazi Health
First posted: 2019-02-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.

Detailed description: In this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (OT) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within Midtown Community Mental Health (MCMH). The investigators hope to accomplish this objective via the following specific aims:1) Assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within MCMH sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) Adapt an existing care model - the Art of Healing Wellness Model (AoHW) - to meet the needs of MCMH, implement the model using an OT practitioner, and track feasibility/acceptability outcomes. 3) Re-assess MCMH programming post implementation to identify/demonstrate change resulting from the model 4) Using OT in the role of consultant, offer training to current MCMH staff to enable implementation of the adapted AoHW by MCMH (baccalaureate level) care coordinators 5) Preliminarily evaluate usability of the adapted AoHW by MCMH staff via focus groups following training and staff implementation

Eligibility criteria: Inclusion Criteria

• Patient on a pre-determined treatment team at the outpatient mental health recruitment site

Exclusion Criteria

* Under 18
* Pregnant

Primary outcomes:
measure: Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi - Midtown Community Mental Health (James Wright Center)
state: Indiana
Study officials:
References: