louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04803500: Simvastatin Around Immediate Implant
Official title: Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immediate Implant Placement
Bone Regeneration
Alveolar Bone Resorption
Keywords: Simvastatin
Immediate implant placement
gap distance
ridge dimension alteration
cone beam computed tomopgraphy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

Brief summary: The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.


Eligibility criteria: Inclusion Criteria:

* Patients between 20 and 50 years old
* requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch
* following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin
* at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability

Exclusion Criteria:

* unstable systemic diseases precluding surgical procedures
* compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy
* pregnancy
* compromised healing conditions e.g. uncontrolled diabetes mellitus

Primary outcomes:
measure: Effect of simvastatin on gap fill
timeFrame: 3 months after implant placement
measure: Effect of simvastatin on horizontal ridge dimension
timeFrame: 3 months after implant placement
measure: Effect of simvastatin on crestal bone level
timeFrame: 3 months after implant placement
measure: Effect of simvastatin on bone density
timeFrame: 3 months after implant placement
Secondary outcomes:
measure: Quality of wound healing
timeFrame: 1 week after implant placement
measure: Quality of wound healing
timeFrame: 2 weeks after implant placement
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00046800: Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
Official title: A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: Ovarian Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2002-10-04
Enrollment: 80
Sex: FEMALE
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 estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed relapsed ovarian cancer.
* Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan).
* One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin.
* At least three weeks since prior chemotherapy and recovery from any related toxicities.
* At least four weeks since prior radiotherapy and recovery from any related toxicities.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU- Kaplan Comprehensive Cancer Center
state: New York
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center, Centennial Medical Center
state: Tennessee
city: Birmingham
country: United Kingdom
facility: St Chad's Unit
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
city: Guildford, Surrey
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Royal Marsden NHS Trust
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Research, Newcastle General Hospital
city: Northwood, Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Sutton Surrey
country: United Kingdom
facility: CRC Department of Medical Oncology
city: Taunton
country: United Kingdom
facility: Taunton & Somerset Hospital
city: Torquay
country: United Kingdom
facility: Medical Oncology Unit, Torbay District General Hospital
Study officials:
References:
Clinical trial NCT00642200: Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty
Official title: Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Inguinal Hernia
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Kuopio Computing Center
First posted: 2008-03-24
Enrollment: 100
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 study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.


Eligibility criteria: Inclusion Criteria:

* recurrent inguinal hernia
* willing to participate

Exclusion Criteria:

* unwilling to participate
* bilateral hernia
* preference towards either treatment arm

Primary outcomes:
measure: further recurrence
timeFrame: 3 weeks, 1 year, 2 years, 3 years
Secondary outcomes:
measure: chronic pain or discomfort
timeFrame: 3 weeks, 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital - Clinic of Surgery
state: North Karelia
Study officials:
References:
citation: Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.
Clinical trial NCT00841100: Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
Official title: Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phenylketonuria
Keywords: PKU
Kuvan
BH4
tetrahydrobiopterin
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 21
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet.

Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan responsiveness.


Eligibility criteria: Inclusion Criteria:

* all patients with a diagnosis of phenylketonuria
* patients who are over the age of 4 years,
* patients with a fasting blood phenylalanine ≥600µmol/l

Exclusion Criteria:

* female patients who are pregnant or attempting to become pregnant
* children under four years of age
* Concurrent disease of condition that would interfere with study participation or safety such as history of neurological compromise or major medical, psychiatric or learning disorder unrelated to PKU
* Any condition that, in the view of the Investigators, places subject at high risk of poor treatment compliance or of not completing the study
* Use of L-Dopa, methotrexate, or other drugs that may inhibit folate metabolism

Primary outcomes:
measure: Percent Change in Blood Phenylalanine
timeFrame: Baseline to Day 1 of the Acute Phase, Baseline to Day 28 of Phase 1, Baseline to Day 28 of Phase 3
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Department of Biochemistry & Molecular Biology
state: Florida
Study officials:
affiliation: University of Miami
name: Louis J Elsas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burton BK, Grange DK, Milanowski A, Vockley G, Feillet F, Crombez EA, Abadie V, Harding CO, Cederbaum S, Dobbelaere D, Smith A, Dorenbaum A. The response of patients with phenylketonuria and elevated serum phenylalanine to treatment with oral sapropterin dihydrochloride (6R-tetrahydrobiopterin): a phase II, multicentre, open-label, screening study. J Inherit Metab Dis. 2007 Oct;30(5):700-7. doi: 10.1007/s10545-007-0605-z. Epub 2007 Sep 12.
Clinical trial NCT01730300: Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems
Official title: Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2012-11-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis

Brief summary: The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine bleeding. The patients were asked urogenital distress inventory (UDI) (which includes; irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact questionnaire (IIQ) (which includes; physical activity, travel, social/relationships, emotional health)questionnaires in the day of application LNR-IUD and six months later this procedure. Statistical analyse will be performed to evaluate the changes in this time period.


Eligibility criteria: Inclusion Criteria:

* women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis

Exclusion Criteria:

* none

Primary outcomes:
measure: Urinary frequency
timeFrame: 6 months
Secondary outcomes:
measure: social activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
name: Murat Ekin, M.D.
role: STUDY_CHAIR
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
name: Cihan Kaya, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
name: Mehmet E Ayag, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ekin M, Cengiz H, Ayag ME, Kaya C, Yasar L, Savan K. Effects of the levonorgestrel-releasing intrauterine system on urinary symptoms in patients with adenomyosis. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):517-20. doi: 10.1016/j.ejogrb.2013.07.019. Epub 2013 Aug 3.
Clinical trial NCT05301400: Marginal Bone Loss in Single Implant Restaurations With Different Methods
Official title: Marginal Bone Loss in Single Implant Restaurations With Three Different Methods
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Loss
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar

Detailed description: The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants

Eligibility criteria: Inclusion Criteria:

* patients with single implants restaurations treated in Leon University

Exclusion Criteria:

* pregnant
* mayor heath issues
* patients who do not agree to participate

Primary outcomes:
measure: Rate of marginal loss in single dental implants
timeFrame: 6 months
Secondary outcomes:
measure: Number of Implants with Prosthetic complications
timeFrame: 6 months
Other outcomes:
Locations:
city: León
country: Spain
facility: Universidad de Leon
state: Leon
Study officials:
affiliation: Universidad de León
name: Jesus Seco
role: STUDY_DIRECTOR
References:
Clinical trial NCT03723200: Analyzes of Hemorrhagic Obstetric Patients Whose Were Used Fibrinogen
Official title: Treatment of Obstetric Hemorrhage With Fibrinogen and Blood Products: Retrospective Analyzes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: Hemorrhagic
Obstetric
Fibrinogen
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Obstetric patients who underwent surgery and followed in ICU and Used Fibrinogen and Blood products in peroperatively or postoperatively

Brief summary: The files of hemorrhagic obstetric patients undergoing surgery and followed in the intensive care unit and using Fibrinogen and blood products were included in the study between January 2015- September 2018 at the Anesthesiology and Reanimation Clinic of SBU Kanuni Sultan Süleyman Training and Research Hospital. Patients under 18 years of age were excluded from the study. In this study, ages, operation types, number of blood and products, the amount of fibrinogen, the results of the hemogram and bleeding parameters, the levels of fibrinogen, the duration of hospital stay and the intensive care unit were recorded.

Detailed description: Bleeding is an important event that threatens the patient's life. Too much blood and blood products can be used in massive bleeding. However, unwanted allergic reactions may occur in blood and blood product transfusions. Fibrinogen is the first coagulation factor in coagulopathy. Some studies have shown that when the fibrinogen level falls to \<150-200 mg / dl, the bleeding increases dramatically.

Eligibility criteria: Inclusion Criteria:

* Obstetric patients, underwent surgery and followed in ICU
* Used Fibrinogen and Blood products
* Over 18 years age

Exclusion Criteria:

* Under 18 years age
* Obstetric patients, underwent surgery but not used Fibrinogen and Blood products

Primary outcomes:
measure: Measurement of fibrinogen (mg/L)
timeFrame: 24 hours
measure: Measurement of hemoglobin (g/dL)
timeFrame: 24 hours
measure: Amount of fibrinogen consantrates
timeFrame: 24 hours
measure: Amount of blood products (unit)
timeFrame: 24 hours
Secondary outcomes:
measure: Hospital stay days
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Education and Training Hospital
state: Kucukcekmece
Study officials:
affiliation: Kanuni Sultan Suleyman Education and Training Hospital
name: Ayca Sultan Sahin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363700: Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Official title: Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT

Brief summary: The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Provided signed, written informed consent.
* Has a positive result from an allergen-specific IgE antibody test.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Mean Ocular Itching Score Compared to Placebo Period1
timeFrame: Visit 5 (3, 5, and 10 minutes post-CAC)
measure: Mean Hyperemia Score Compared to Placebo Period1
timeFrame: Visit 5 (5, 10, and 20 minutes post-CAC)
Secondary outcomes:
measure: Mean Ocular Itching Score Compared to Olopatadine Period2
timeFrame: Visit 7 (3, 5, and 10 minutes post-CAC)
measure: Mean Hyperemia Score Compared to Olopatadine Period2
timeFrame: Visit 7 (5, 10, and 20 minutes post-CAC)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
citation: Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.
Clinical trial NCT04761900: MAFLD-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes
Official title: Metabolic Associated Fatty Liver Disease-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes in Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Associated Fatty Liver Disease
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 3372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adults who took annual health check-ups were enrolled in this study during 2012.

Brief summary: Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries.

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver diseases. It affects nearly 25% of the global population. Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries. It may provide a better understanding of MAFLD, and optimize strategies for prevention of extrahepatic complications in clinical practice.

Eligibility criteria: Inclusion Criteria:

* diagnosed ad fatty liver by ultrasound

Exclusion Criteria:

* Missing data on Ultrasound, blood glucose, BMI and metabolic status.

Primary outcomes:
measure: Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of T2DM, hypertension, and carotid atherosclerotic plaque.
timeFrame: 7 years in a cohort study
Secondary outcomes:
measure: Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of hypertension
timeFrame: 7 years in a cohort study
measure: Comparison of different groups in MAFLD and MAFLD-simplified definition for the outcome of carotid atherosclerotic plaque.
timeFrame: 7 years in a cohort study
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Chengfu Xu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901000: Outcome of LA Versus GA for Staged CEA Prior To CABG
Official title: Outcome of Local Versus General Anesthetic for Staged Carotid Endarterectomy Prior To CABG, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Diseases
Coronary Artery Disease
Stroke
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: University Hospital Birmingham
First posted: 2021-05-25
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-hospital patients referred by Cardiothoracic for carotid endarterectomy prior to CABG.

Brief summary: A retrospective analysis of all patients that underwent carotid endarterectomy (CEA) for stenotic disease - diagnosed at pre-operative investigation - prior to CABG as staged operation within 6- months.

The rate of postoperative stroke and complications was compared between CEA performed under Local anaesthetic (LA) to those performed under General anaesthetic (GA).

Detailed description: The primary outcome was the rate of postoperative stroke in patients that had staged CEA prior to CABG. This was defined as CEA within a period of 4 weeks prior to CABG.

We retrospectively looked at those patients that fulfilled the inclusion criteria and had CEA performed either under LA (Group A) or under GA (Group B). We measured the 30 days' postoperative stroke rate as the main outcome. We also looked at the rate of intraoperative stroke.

Additionally, we assessed the rate for developing nerve injuries and/or hematoma postoperatively. Finally, we examined the risk for developing postoperative stroke in patients with bilateral significant carotid artery disease that underwent surgery in one side.

Eligibility criteria: Inclusion Criteria:

- All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation.

Exclusion Criteria:

* Patients diagnosed with symptomatic carotid disease

Primary outcomes:
measure: Stroke
timeFrame: 30 days
Secondary outcomes:
measure: Major bleeding
timeFrame: 30 days
measure: Minor bleeding
timeFrame: 30 days
measure: Nerve injuries
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: