louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00884936: Identification of Gene Biomarkers in Aging Skin
Official title: Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperpigmentation
Skin Aging
Keywords: Skin
Aging
Dermogenomics
Genetic
Biomarker
Dermatology
Lead sponsor: Interleukin Genetics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 121
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian female subjects between the ages of 20 to 75 years old who are non-smokers with no history of prior alcoholism.

Brief summary: This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to assess the gene expression profile from three different age groups.

Detailed description: The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.

Eligibility criteria: Inclusion Criteria:

* Individuals who are willing to read and sign an informed consent form prior to participating in the study.
* Individuals who have a temperature of less than or equal to 100 degrees F at the time of biopsy collection.
* Individuals who had not applied any sunless tanning product on the arms within the past year.
* Individuals with no prior history of alcoholism (or who consume fewer than 2 to 3 alcoholic beverages per day).
* Individuals who have not consumed any anti-aging nutritional supplements (multivitamins and multiminerals are acceptable) or aspirin, NSAIDS, or other pain medication in the last 48 hours before biopsy.

Exclusion Criteria:

* Male gender
* Individuals who did not fit the 'inclusion criteria' above.

Primary outcomes:
measure: The primary objective of the study is to investigate changes in gene expression patterns that occur during the aging process. A significant fold change in differential gene expression will be >1.5 and an adjusted p-value of <0.05.
timeFrame: 1 year
Secondary outcomes:
measure: Secondary outcome measures are the evaluation of genetic expression changes in sun-protected and sun-exposed skin and an investigation of their biological pathways.
timeFrame: 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Thomas J. Stephens & Associates, Japan Research Center
Study officials:
affiliation: Interleukin Genetics
name: Prakash Prabhakar, PhD
role: STUDY_DIRECTOR
affiliation: Interleukin Genetics
name: Karen Shaver, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03651336: Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Official title: A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open-angle Glaucoma
Keywords: POAG
Primary Open Angle Glaucoma
Cataract
Intraocular Pressure
Intraocular Pressure Sensor System
IOP
Self-monitoring of intraocular pressure
Lead sponsor: Implandata Ophthalmic Products GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)

Detailed description: This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.

From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.

Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.

The sensor was always implanted in one eye only which will be the study eye.

Eligibility criteria: Inclusion Criteria:

* Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
timeFrame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
measure: Performance: Level of Agreement Between GAT and the ARGOS-IO System
timeFrame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
measure: Performance: Device Malfunctions
timeFrame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Secondary outcomes:
measure: Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)
timeFrame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
measure: Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)
timeFrame: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Klinik für Augenheilkunde, Uniklinik RWTH Aachen
city: Bochum
country: Germany
facility: Universitäts-Augenklinik Bochum
city: Magdeburg
country: Germany
facility: Universitätsaugenklinik Magdeburg
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik Tübingen
Study officials:
affiliation: Universitätsaugenklinik Magdeburg
name: Hagen Thieme, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01762436: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
Official title: A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Untreated Essential Hypertension
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 109
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* 25\~65 years old
* untreated essential hypertension
* SBP 140-160mmHg \& DBP 90-100mmHg
* Sinus rhythm
* Resting heart rate \>70bpm
* Can give written informed consent

Exclusion Criteria:

* Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade(AVBⅡ-Ⅲ) without pacemaker
* Bradyarrhythmia/ hypotensive
* Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
* Uncontrolled diabetes mellitus (DM)
* Bronchial asthma
* Gastro-intestinal ulcer or skin ulcer
* Liver dysfunction/ renal impairment
* Treated with CCB (Calcium antagonists) ( except amlodipine) or other beta blocker.
* Glaucoma
* Known allergic/ intolerance to beta blocker
* Pregnant or lactating women
* Participation in another clinical study within the last 3 months
* Legal incapacity or limited legal capacity

Primary outcomes:
measure: baroreflex sensitivity
timeFrame: 4~8 weeks
measure: central aortic pressure
timeFrame: 4~8 weeks
Secondary outcomes:
measure: heart rate variability
timeFrame: 4~8 weeks
measure: peripheral blood pressure
timeFrame: 4-8 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension and Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
citation: Zhou WJ, Wang RY, Li Y, Chen DR, Chen EZ, Zhu DL, Gao PJ. A randomized controlled study on the effects of bisoprolol and atenolol on sympathetic nervous activity and central aortic pressure in patients with essential hypertension. PLoS One. 2013 Sep 10;8(9):e72102. doi: 10.1371/journal.pone.0072102. eCollection 2013.
Clinical trial NCT06677736: Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: a Relation to Periodontal Inflammaging
Official title: Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: a Relation to Periodontal Inflammaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Keywords: inflamaging
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 40
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: Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging

Detailed description: Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Aged below 40 or above 60.
3. Have at least 16 natural teeth excluding wisdom.
4. Provide informed consent and willingness to cooperate with study protocol.
5. Periodontitis stage II patients (23):

   * CAL from 3-4 mm.
   * Radiographic bone loss (15% to 33%).
   * No tooth loss due to periodontitis.
   * Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

* 1- Patients with any smoking habits 2- History of antibiotics in the previous three months. 3- Pregnant or lactating female. 4- Treatment with any systemic drug. 5- History of systemic disease. 6- Patients who received periodontal treatment in the last 6 months

Primary outcomes:
measure: Clinical attachment loss
timeFrame: Base line , follow up after 1 month , second follow up after 6 months
measure: Gingival index
timeFrame: base line, follow up after 1 month, second follow up after 6 months
measure: Toll like receptor - 4
timeFrame: base line, follow up after 1 month, second follow up after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr university for science and technology
Study officials:
References:
Clinical trial NCT01646736: Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis
Official title: Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Nephritis, Lupus
Keywords: Lupus Nephritis
Cyclophosphamide
Tripterygium
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years with informed consent
* SLE defined by meeting 4 or more ACR classification criteria
* Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
* Active renal disease

Exclusion Criteria:

* Pregnant, lactating or further fertility requirements
* Serum creatinine \> 3 mg/dL
* Serum ALT or AST \> 3 times upper limit of normal
* Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
* Previous treated with cyclophosphamide or T2.
* Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
* Active or chronic infection, including HIV, HCV, HBV, tuberculosis
* Patient with malignancy

Primary outcomes:
measure: Renal Response
timeFrame: 24 weeks.
Secondary outcomes:
measure: Renal Function
timeFrame: 24 weeks
measure: Serum Albumin Level
timeFrame: 24 weeks
measure: Complement
timeFrame: 24 weeks
measure: Anti-dsDNA
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deptment of Rheumatology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fengchun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711436: Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Cellulitis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare orbital and central nervous system (CNS) imaging with Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in children with mild, moderate or severe orbital cellulitis with medical indications for imaging.


Eligibility criteria: Inclusion Criteria:

* Children with orbital cellulitis with indications for imaging

Exclusion Criteria:

* All others

Primary outcomes:
measure: MRI sensitivity for the detection of orbital cellulitis compared to CT
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yuval Cohen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363336: Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
Official title: Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Adalat
Hypertension
Diabetes
Chronic kidney disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 1882
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patient who have been administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease. The study is expected to collect data of 2,000 pateints in Japan.

Brief summary: This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)

Exclusion Criteria:

* CKD with stage 5
* CDK with dialysis

Primary outcomes:
measure: Evaluation of participants with Adverse Events for Safety purpose in real practice
timeFrame: After 6 months
measure: General evaluation of patient concerning efficacy of AdalatCR treatment in real practice
timeFrame: After 6 months
Secondary outcomes:
measure: Blood pressure, Pulse rate
timeFrame: After 6 months
measure: Clinical test values, in specially, microalbumin urea and serum creatinine
timeFrame: After 6 months
measure: Overall evaluation
timeFrame: After 6 months
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06456736: Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
Official title: Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Encephalitis
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients admitted to the ICU for AE.

Brief summary: Autoimmune encephalitis (AE) is a potentially life-threatening inflammation of the central nervous system (CNS) and constitutes 20%-30% of encephalitis cases in adults AE often leads to subacute, severe, and debilitating encephalitis necessitating long-term management in a neurologic intensive care unit (ICU). This study aims to explore the predictive factors for poor clinical outcomes by analyzing the clinical characteristics and prognosis of adult patients with critical AE requiring ICU admission. Prospective observational single center study in neurologic ICU, the second Xiangya hospital, Central South University. All patients admitted to the ICU for probable or confirmed AE (2022 Chinese guidelines for diagnosis and treatment of AE) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as either ''definite'' or ''probable'' AE based on Chinese guidelines for diagnosis and treatment of AE (version 2022)
* Age ≥ 15 years
* Admission to an adult ICU during the course of the disease

Exclusion Criteria:

* Missing data on primary outcome
* ICU length of stay of 24 hours or less.

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 12 months
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: Rate of complications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00038636: A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
Official title: A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-06-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir


Eligibility criteria: Inclusion:

* HIV positive
* Are at least 18 years old
* Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
* HIV RNA level \> 1000 copies/mL
* Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor

Exclusion:

* Subject is pregnant or breast-feeding
* Subject has received an investigational drug within 30 days prior to screening
* Have a history of pancreatitis
* History of intolerance to ritonavir
* Abnormal laboratory tests at screening

Primary outcomes:
measure: Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Treatment Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Hospital Europeen Georges Pompidou
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Barcelona
country: Spain
facility: Ciutat Sanitaria de Bellvitge
Study officials:
affiliation: Divisional Vice President, Infectious Diseases and Virology Dept.
name: Eugene Sun, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00524836: Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis
Official title: A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Allergic
Perennial
Keywords: levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male ore female, 16 to 60 years old (inclusive)
* two-year history of allergic rhinitis due to house dust mite

Exclusion Criteria:

* An ear, nose or throat (ENT) infection
* asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
* an associated ENT disease
* use of decongestants
* nasal or ocular topical treatment
* desensitivation

Primary outcomes:
measure: Total 5 Symptom Score (T5SS) rated by the investigator
timeFrame: 2 weeks
Secondary outcomes:
measure: Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI).
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: