louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00189137: Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Official title: Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 84
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Detailed description: The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

Eligibility criteria: Inclusion Criteria:

* no evidence of metastasis
* soft tissue sarcoma
* intermediate or high histologic grade
* greater than 5 cm
* Zubrod performance status 1 or better
* age 10 or older

Exclusion Criteria:

* clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
* prior chemotherapy
* nephrectomy
* active unstable angina pectoris
* concurrent therapy

Primary outcomes:
measure: Percentage of Patients Hospitalized in Each Arm.
timeFrame: 12 weeks
Secondary outcomes:
measure: The Percentage of Patients Alive Without Disease at 2 Years
timeFrame: 2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Scott Schuetze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis EJ, Zhao L, Lucas DR, Schuetze SM, Baker LH, Zalupski MM, Thomas D, Chugh R. SPARC expression in patients with high-risk localized soft tissue sarcoma treated on a randomized phase II trial of neo/adjuvant chemotherapy. BMC Cancer. 2016 Aug 20;16:663. doi: 10.1186/s12885-016-2694-2.
Clinical trial NCT05539937: Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.
Official title: Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis. (TAVI QdV)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Aortic Valve Replacement
Transfemoral Approach
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: Belledonne clinic
name: European Clinical Trial Experts Network
First posted: 2022-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who will have benefited of a transfemoral percutaneous aortic valve replacement; male or femal over 18 years of age.

Brief summary: In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred.

A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.


Eligibility criteria: Inclusion Criteria:

* Male, female, over 18 years old,
* All patients who will have transfemoral percutaneous aortic valve replacement (TAVI) with implantation of a valve delivered on a balloon,
* Patient able to understand the study, and answer the TASQ questionnaire,
* Affiliation to a social security scheme or beneficiary of such a scheme,
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Minor,
* Disorder of comprehension and/or expression,
* Patients unable to answer questions due to an underlying cognitive deficit or physical disability,
* Patients treated with a self-expanding valve,
* Refusal to participate in the study,
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
* Pregnant, parturient, or breast-feeding patient.

Primary outcomes:
measure: Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Rochette
country: France
facility: Jean-François Oudet
Study officials:
References:
Clinical trial NCT01439737: Metabolomic Analysis of Exhaled Breath Condensate in Asthmatics
Official title: Metabolomic Analysis of Exhaled Breath Condensate, Plasma and Urine Specimens in Adult Asthmatics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
metabolomics
exhaled breath condensate
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult asthmatics

Brief summary: Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the clinical manifestations and treatment responses in these patients. Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now, few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. This study will apply metabolomics to examine the biomarkers in the EBCs, serum and urine specimens in adult asthmatics.

Detailed description: The aims of this study are: 1. Metabolomic profiling of the exhaled breath condensate (EBC), serum and urine specimens in adult asthmatics; 2. Correlation between metabolomic profiles of these specimens with the severity and control of asthma; 3. Comparing metabolomic profiles in asthmatics with different phenotypes and endotypes; 4.Comparing metabolomic profiles obtained from asthmatics during stable and acute exacerbation periods; 5. Comparing metabolomic profiles in asthmatics before and after inhaled corticosteroid therapy.

Eligibility criteria: Inclusion Criteria:

1. 20-90 years
2. Diagnosis of asthma based on the GINA guideline

Exclusion Criteria:

1. Patient with cancer
2. Patient with long-term ventilator use

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Internal Medicine, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ping-Hung Kuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01767337: Intracutaneous Delivery of Varied Dose Volumes of Saline
Official title: Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: microneedle-based delivery
hollow microneedle
intracutaneous
drug delivery
Lead sponsor: FluGen Inc
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
First posted: 2013-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the FLUGEN 101.2 investigational microneedle-based device.

Detailed description: An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.

Eligibility criteria: Inclusion Criteria:

* Able to read and/or understand and sign the Informed Consent form

Exclusion Criteria:

* Medical history of acute or chronic skin disease
* Active skin allergy or acute skin infection, presence of tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
* Hirsute at any prospective injection site
* Diabetes
* High levels of anxiety or depression or history of psychosis
* Abuse of alcohol or use of other drugs of abuse including tobacco
* Pregnant or breastfeeding women
* Any medical condition that may interfere with study protocol adherence including completion of study activities
* Foreseeable inability to complete the study as scheduled.

Primary outcomes:
measure: The primary objective is to evaluate the safety and tolerability/reactogenicity of various saline volumes delivered from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
timeFrame: 30 minutes, 24 hours, ~ 1 week
Secondary outcomes:
measure: A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Accelovance Inc
state: Florida
Study officials:
affiliation: FluGen Inc
name: Renee Herber
role: STUDY_DIRECTOR
affiliation: Accelovance
name: Murray A Kimmel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00299637: Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis
Official title: Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis During Labor Comparing to Fetuses to Healthy Mothers.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chorioamnionitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-03-07
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery.

Detailed description: This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery.

MCA flow parameters will be evaluated during labor of women with and wthout chorioamnionitis

Eligibility criteria: Inclusion Criteria:

* women giving birth week 37-42
* healthy
* one fetus

Exclusion Criteria:

* more than one fetus
* IUGR
* illness or damage to fetus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Haddasah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: David Mankuta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03067337: Evaluation Between Zirconia and Stainless Steel Crowns
Official title: Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Diseases
Keywords: Stainless Steel Crowns
Zirconia Crowns
Aesthetic restorations
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction and Research Problem:

The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).

Materials and Methods:

Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who need restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing variables for both groups, each patient will have side restored with SSC and the opposite side will be restored with Nu/ZR crowns.

Randomization will be done using Statistical Package for the Social Sciences (SPSS) software version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for each age group separately with a uniform random variable generation. A simple descriptive statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used. Level of significance will be set at (α = 0.05) and level of confidence at (95%).


Eligibility criteria: Inclusion Criteria:

* Age group of 4-8 years
* Free of any systemic disease
* Cooperative patient
* At least two matched bilateral carious primary molars
* Minimal of two surfaces of caries in the targeted tooth
* Written consent obtained from the parent/guardian

Exclusion Criteria:

* Any subject that does not fall under the inclusion criteria were excluded.

Primary outcomes:
measure: Gingival health
timeFrame: 3-month follow-up
measure: Plaque index
timeFrame: 3-month follow-up
measure: Restoration failure
timeFrame: 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01526837: Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
Official title: A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma Multiforme
Keywords: Brain tumor
GBM
Brain cancer
Lead sponsor: Brain & Spine Surgeons of New York
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 1
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: This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.


Eligibility criteria: Inclusion Criteria:

1. Recurrent Glioblastoma
2. At least 12 weeks expected survival (KPS \>60)
3. 18 years of age or older
4. Able and willing to participate

Exclusion Criteria:

1. Any prior diagnosis of any other cancer or other concurrent malignancy.
2. Planned use or current use of other investigation therapy.
3. Systemic autoimmune disease
4. HIV positive
5. Concurrent life threatening disease
6. Impaired organ function
7. Active infection
8. Inadequately controlled hypertension
9. Congestive heart failure
10. Myocardial infection/unstable angina within 6 months
11. Stroke within 6 months
12. Pheripheral vascular disease
13. History of abdominal fistula/gastrointestinal performation
14. Non-healing wound
15. Coagulation disease
16. Known allergy to study treatments
17. Pregnant or lactating

Primary outcomes:
measure: Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
measure: Progression Free Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Brain & Spine Surgeons of New York
state: New York
Study officials:
affiliation: Brain & Spine Surgeons of New York
name: John Abrahams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BSSNY
name: Jan Strack
role: STUDY_DIRECTOR
References:
Clinical trial NCT01404637: Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
Official title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 150
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
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 compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.


Eligibility criteria: Inclusion Criteria:

* Severe LUTS : IPSS ≥ 20

Exclusion Criteria:

* Post voided residual urine ≥ 150mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to tamsulosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)

Primary outcomes:
measure: Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
timeFrame: 4 weeks and 12 weeks of treatment
measure: Changes of parameters in voiding diary after 4 and 12 weeks treatment.
timeFrame: 4 weeks and 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13.
Clinical trial NCT03107637: Transesophageal Echocardiography in Embolic Stroke of Undetermined Source
Official title: Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Embolic Stroke of Undetermined Source
Ischemic Stroke
Keywords: Embolic Stroke of Undetermined Source
transesophageal echocardiography
cardiac source of embolism
ischemic stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-04-11
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for ichemic stroke meeting embolic source of unknown source criteria

Brief summary: The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.


Eligibility criteria: Inclusion Criteria:

* Presenting with a new onset of ischemic stroke
* Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
* Comprehensive transthoracic echo prior to the TEE

Exclusion Criteria:

* ESUS criteria not met
* Contraindications to TEE
* TEE failure
* Pregnant or breastfeeding woman
* Person under legal protection
* No medical insurance coverage

Primary outcomes:
measure: therapeutic modification after transesophageal echocardiography
timeFrame: 24 hours after TEE
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Nadia Benyounes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02262637: Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)
Official title: Micardis® / MicardisPlus® PROTEKT (Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 4814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with hypertension recruited at Cardiologists, Nephrologists, Diabetologists

Brief summary: Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Change in systolic blood pressure (SBP)
timeFrame: baseline, up to 6 months
measure: Change in diastolic blood pressure (DBP)
timeFrame: baseline, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: