louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01114581: Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Infection
Keywords: Acute Respiratory Infection
Mucociliary
Cough Clearance
Guaifenesin
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 38
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: The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.


Eligibility criteria: Inclusion Criteria:

* Symptoms of cough, thickened mucus and chest congestion
* Able to produce sputum
* Non Smoker

Exclusion Criteria:

* Pregnant
* Smokers
* Fever above 101°F
* Any chronic illness

Primary outcomes:
measure: Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
timeFrame: 3 hours following inhalation of radioactive tracer particles
Secondary outcomes:
measure: Guaifenesin AUC(0-3)
timeFrame: 3 hours following dose administration
measure: Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
timeFrame: Within 10 days of developing symptoms associated with a respiratory tract infection
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Center for Environmental Medicine, Asthma, and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: William Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.
Clinical trial NCT01527981: Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
Official title: CBT for Adherence and Depression in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Type 1 Diabetes
Keywords: Depression
Diabetes
Adherence
Medication
Glucose
Insulin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pilot behavioral intervention trial, designed to initially examine cognitive behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression and poorly controlled type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes that is poorly controlled (HbA1C greater than or equal to 8.0%) despite treatment with insulin.
* Diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
* Age 18-80.
* If on an antidepressant, stable for two months. Oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).

Exclusion Criteria:

* Active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
* Unable or unwilling to provide informed consent.
* History of or current CBT for depression.
* Currently on dialysis.

Primary outcomes:
measure: Changes in glucose monitoring
timeFrame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
measure: Changes in insulin adherence
timeFrame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
measure: Changes in depression severity
timeFrame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
Secondary outcomes:
measure: Changes in hemoglobin A1C
timeFrame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
measure: Changes in glucose levels
timeFrame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven A Safren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Markowitz SM, Carper MM, Gonzalez JS, Delahanty LM, Safren SA. Cognitive-behavioral therapy for the treatment of depression and adherence in patients with type 1 diabetes: pilot data and feasibility. Prim Care Companion CNS Disord. 2012;14(2):PCC.11m01220. doi: 10.4088/PCC.11m01220. Epub 2012 Mar 15.
Clinical trial NCT02045381: Optimization of MRI for Radiation Therapy
Official title: Optimization of MRI for Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Liver
Cancer Brain
Cancer Head &Neck
Cancer Pelvis
Keywords: Cancer
MRI
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants having a working diagnosis of malignancy in the liver, brain, head and neck, or pelvis, and a plan to treat with radiotherapy.

Brief summary: Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age
* A working diagnosis of malignancy in the liver, brain, H\&N, or pelvis
* A plan to treat with radiotherapy

Exclusion Criteria:

* Patients with contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department.

Primary outcomes:
measure: Percentage of participants with MRI images suitable for analyses
timeFrame: Day One
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univeristy of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Shruti Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081781: The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
Official title: Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Nasolacrimal Duct Obstruction
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.

Detailed description: Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.

Eligibility criteria: Inclusion Criteria:

* a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
* anatomical nasolacrimal duct obstruction

Exclusion Criteria:

* previous probing
* glaucoma
* trauma
* lid malpositions
* craniofacial anomalies
* congenital mucocele of the nasolacrimal sac

Primary outcomes:
measure: probing success: both anatomical patency of the duct and functional free of symptoms
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, Cathay General Hospital
Study officials:
affiliation: Department of Ophthalmology, Cathay General Hospital
name: Chih Heng Hung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pediatric Eye Disease Investigator Group; Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. doi: 10.1016/j.ophtha.2007.07.030. Epub 2007 Nov 8.
citation: Miller AM, Chandler DL, Repka MX, Hoover DL, Lee KA, Melia M, Rychwalski PJ, Silbert DI; Pediatric Eye Disease Investigator Group; Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Quinn GE, Sala NA, Schloff S, Wallace DK, Foster NC, Frick KD, Golden RP, Lambert SR, Tien DR, Weakley DR Jr. Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS. 2014 Feb;18(1):26-30. doi: 10.1016/j.jaapos.2013.10.016.
Clinical trial NCT02642081: Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure
Official title: Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: NSAIDs
Heart failure
Acute kidney injury
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with prescription of NSAIDs

Brief summary: The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.


Eligibility criteria: Inclusion criteria

1. Patient's age was more than 20 years old
2. Diagnosis of heart failure
3. With prescription of NSAIDs (only oral and intravenous form are included)

Exclusion criteria

1. With prescription of NSAIDs administered by topical use
2. Patient was pregnant

Primary outcomes:
measure: Change from baseline in serum creatinine at 1 month
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Admission for acute decompensated heart failure
timeFrame: 1 month after exposure to NSAIDs
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chii-Ming Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475981: Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
Official title: Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: JTK-853
single dose
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) of 18-30 kg/m2 (inclusive)
2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

Exclusion Criteria:

1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 1 week
measure: Maximum concentration (Cmax) of JTK-853 and metabolite M2
timeFrame: 1 week
measure: Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2
timeFrame: 1 week
measure: Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2
timeFrame: 1 week
measure: Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2
timeFrame: 1 week
measure: Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD, Phase I Clinic
state: Texas
Study officials:
affiliation: Akros Pharma Inc.
name: Shoji Hoshino, D.V.M
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186095: Mixed Chimeric Transplantation for Primary Amyloidosis
Official title: Mixed Chimeric Transplantation for Primary Amyloidosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amyloidosis
Keywords: Amyloidosis
nonmyeloablative
hematopoietic
cell transplantation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.


Eligibility criteria: Inclusion Criteria:

* primary amyloidosis
* adequate organ function
* matched sibling donor

Exclusion Criteria:

* evidence of multiple myeloma
* HIV positive

Primary outcomes:
measure: Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis.
Secondary outcomes:
measure: Toxicity of therapy
measure: Changes in marrow and serum abnormalities
measure: Improvement in end-organ function.
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Keith Stockerl-Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00951795: Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
Official title: Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infection
AIDS
HIV Infections
Keywords: HIV
AIDS
CD4
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
Collaborators: name: Inverness Medical Innovations
First posted: 2009-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended study population is individuals with confirmed diagnosis of HIV infection ≥ 12 years of age presenting to a physician's office or outpatient clinic.

Brief summary: This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Detailed description: Blood samples will be collected from HIV infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. Capillary whole blood samples will be obtained by fingerstick in duplicate from all Subjects in the study for immediate measurement of CD4+ T-cell count on the Pima CD4 Test by a trained healthcare professional. Venous whole blood samples from all Subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. Venous samples from all Subjects in the study will also be measured on the Pima CD4 Test at the study site. Hematocrit will also be measured for all Subjects.

Eligibility criteria: Inclusion Criteria:

1. 12 years of age or older
2. Confirmed HIV infection, HIV-1 or HIV-2 according to medical history (this inclusion will be waived for healthy non-HIV infected individuals who may need to be enrolled in order to fill the high end of the CD4+ T-cell measurement range of the Pima CD4 Test.
3. Subject agrees to complete all aspects of the study

Exclusion Criteria:

1. Subject has already participated in this study at a previous date
2. Subject is enrolled in a study to evaluate a new drug
3. Patient unable or unwilling to provide informed consent
4. Vulnerable populations as deemed inappropriate for study by site principal investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT04270695: Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
Official title: Effects of Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Flow Restriction
draw-in Maneuver
Transverse Abdominis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study expects to provide a new alternative way to improve the muscle activation, strength and activation of transverse abdominis in abdominal draw-in maneuver combined with blood flow restriction.

Detailed description: The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal wall and also known as a significant component of core stability. Abdominal draw-in maneuver (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with low intensity exercise that produces similar results to high intensity training. However, there is few evidences for BFR training on core muscles.

Healthy adults (age ranged 18-34 years and BMI between 18.5\~24.99) were randomly recruited in the study. For the intervention group, an inflatable cuff (14 cm in width \* 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform ADIM both condition of BFR and BFR-free twice a week, for six weeks. Outcome measurements include Double leg lowering test (DLLT) for muscle strength, brightness mode ultrasound (USD) for muscle hypertrophy and electromyography (EMG) muscle activation. The same physical therapist will do the measurement at first week, third week and the sixth week.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* 20\~35 years old
* BMI 18.5\~24.99

Exclusion Criteria:

* Hypertension
* Have cardio-vascular disease
* Used to have abdominal operation or wound
* Have spinal surgeries or deformities
* Known neuromuscular or joint disease
* Pregnant

Primary outcomes:
measure: Muscle Thickness Change of Transverse Abdominis
timeFrame: 3,4,5 weeks
Secondary outcomes:
measure: Internal Oblique Thickness Change
timeFrame: baseline,3,4,5 weeks
measure: External Oblique Thickness Change
timeFrame: baseline,3,4,5weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: professor
name: Yueh-Ling Hsieh
role: STUDY_DIRECTOR
References:
Clinical trial NCT00395395: Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Official title: A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 56
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.


Eligibility criteria: Inclusion Criteria:

* Healthy postmenopausal women

Exclusion Criteria:

* Previous treatment with other osteoporosis medication

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
Secondary outcomes:
measure: Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
measure: PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
measure: PK profile of salmon calcitonin nasal spray
Other outcomes:
Locations:
city: Multiple Cities
country: Denmark
Study officials:
affiliation: Novartis Basel +41 61 324 1111
name: Novartis Basel
role: STUDY_DIRECTOR
References: