louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05933161: A Study of Glycemic Control in Left Ventricular Assist
Official title: GLYcemic Control Evaluation by Continuous Glucose Monitor Compared With a1C in Left Ventricular Assist Device-supported Patients (GLYCEM1C-LVAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Hyperglycemia
Hypoglycemia
Keywords: Left Ventricular Assist Device (LVAD)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 20
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: Subjects diagnosed with Type 2 Diabetes Mellitus who have a Left Ventricular Assist Device (LVAD) will be recruited from the LVAD clinic at Mayo Clinic in Rochester, MN.

Brief summary: The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.


Eligibility criteria: Inclusion Criteria:

* Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
* Diagnosis of type II diabetes mellitus
* Any antihyperglycemic regimen
* Greater than 3 months out from LVAD implantation
* Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
* Patients may be enrolled who have preexisting CGM in place.

Exclusion Criteria:

* Type I diabetics
* Unable to return at 3 month evaluation
* Unwillingness to participate

Primary outcomes:
measure: Average glucose values based on continuous glucose monitoring
timeFrame: 3 months
measure: Estimated average glucose (eAG) values based on hemoglobin-A1c lab values
timeFrame: 3 months
measure: Estimated average glucose (eAG) values based on fructosamine lab values
timeFrame: 3 months
Secondary outcomes:
measure: Number of adjustments of antihyperglycemic agents
timeFrame: 3 months
measure: Number of hypoglycemic unawareness episodes
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrew Rosenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001061: Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
Official title: Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Missed Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

Detailed description: study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

Eligibility criteria: Inclusion Criteria:

* Women with an ultrasound diagnosis of missed abortion \< 13 weeks gestation without any clinical criteria of Inevitable abortion.

Exclusion Criteria:

* Patients refused the medical treatment.
* Patients have contraindications of the drug (Misoprostol).
* Missed abortion associated with any signs of sepsis

Primary outcomes:
measure: The occurance of complete abortion within 24 hours with Misoprostol drug
timeFrame: Within 24 hours
measure: Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.
citation: Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.
Clinical trial NCT01775761: A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
Official title: A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: TTR Cardiomyopathy
Keywords: Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* An ALT or AST measurement \>2 times the ULN.
* 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening.
* Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
* History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.

Primary outcomes:
measure: QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
timeFrame: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs
Secondary outcomes:
measure: QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.
timeFrame: Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
measure: Tmax
timeFrame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
measure: Cmax
timeFrame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
measure: AUC0-24
timeFrame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561.
Clinical trial NCT05969561: Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.
Official title: Ultrasound-Guided Femoral Nerve Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: Ultrasound-guided femoral nerve block
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In this prospective study, emergency physicians perform ultrasound-guided femoral nerve block for patients with hip fractures. We compare the effectiveness of analgesia and patient satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medicine in the emergency department. The primary outcome is the assessment of time to relief the pain with fewer adverse effects and less rescue pain medication use. The secondary outcome is patient satisfaction and adverse effects for different method of pain control.

Detailed description: The aim of this study is to compare the effectiveness of ultrasound-guided femoral nerve blocks performed by emergency physicians for pain control in the emergency department with traditional pain medicine.

This study is a prospective before-and-after design. The enrollees are 20-year-old and older adult patients with hip fractures. We use numerical rating scale using a 0-10 scale to assess pain severity at the different time frame after giving pain medicine. The scale zero means "no pain" and scale 10 means "the worst pain imaginable".

The primary outcome is assessed by the reduction of pain scale which are taken on a numeric rating scale every 30 minutes before and after pain management. The secondary outcome compares complications, adverse effects and patient satisfaction for different method of pain control.

Eligibility criteria: Inclusion Criteria:

* Patients older than 20-year-old with hip fractures
* Stay in the emergency department for at lease two hours

Exclusion Criteria:

* hemodynamic unstable
* major trauma in addition to hip fractures
* the use of any pain management before the arrival of emergency department
* chronic opioid use
* inability to understood the numerical rating scale after instruction
* allergy to local anesthetics
* coagulopathy
* injection site infection

Primary outcomes:
measure: a short time of pain relief
timeFrame: 2 hours
Secondary outcomes:
measure: Adverse effects
timeFrame: two hours
measure: Patient satisfaction
timeFrame: two hours
measure: Complications of ultrasound-guided femoral nerve block
timeFrame: two hours and one week after ultrasound-guided femoral nerve block or after hospital discharge
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: NTUH Yunlin Branch
state: Yunlin County
Study officials:
References:
Clinical trial NCT03160261: Effect of Exenatide on Cortisol Secretion
Official title: Effect of Exenatide on Cortisol Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group, open-label
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.

Detailed description: Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.

The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.

The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Body weight \>65 kg

Exclusion Criteria:

* Presence of chronic illness
* daily use of any medicines
* pregnancy, lactation
* use of oral contraceptives during previous 2 months

Primary outcomes:
measure: Cortisol peak
timeFrame: every 30 minutes during 2 hours after injection
Secondary outcomes:
measure: Adrenocorticotropin (ACTH) peak
timeFrame: every 30 minutes during 2 hours after injection
measure: Glucose
timeFrame: Glucose measured every 30 minutes during 2 hours after injection
measure: Growth hormone
timeFrame: every 30 minutes during 2 hours after injection
Other outcomes:
measure: heart rate
timeFrame: every 30 minutes during 2 hours after injection
measure: Blood pressure
timeFrame: every 30 minutes during 2 hours after injection
measure: nausea
timeFrame: every 30 minutes during 2 hours after injection
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: Tartu University
name: Vallo Volke, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06392061: Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease
Official title: Assessment of Medical and Nutritional Status Post-Probiotic Intake in Patients Diagnosed With Inflammatory Bowel Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Quality of Life
Food Intolerance
Flare Up
Ulcerative Colitis
Crohn Disease
Lead sponsor: Lebanese University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a single-center, randomized, single-blinded, controlled trial conducted at ZHUMC's endoscopy unit. It aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD).

Patients with UC and CD will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. The intervention probiotic group will receive the probiotic intervention for 2 months. During the study period, two visits will be scheduled for all patients.

At each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. These assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status.

Overall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing IBD and improving the well-being of patients with these conditions.


Eligibility criteria: Inclusion Criteria:

* Lebanese outpatients with histological diagnosis of Crohn's disease or Ulcerative Colitis from at least 6 months prior to the trial.
* have stable inactive disease.
* have not used any probiotics within the two months before the investigation.

Exclusion Criteria:

* pregnant or lactating women
* patients who use probiotics within the study period.

Primary outcomes:
measure: Disease course
timeFrame: 8 weeks
measure: Disease course
timeFrame: 8 weeks
measure: Nutrition Status
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of Life Status
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: zahra Sadek
Study officials:
affiliation: Al Zahraa Hospital University Medical Center
name: Mahmoud Hallal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065961: Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis
Official title: Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Swallowing
Keywords: anterior
cervical
fusion
swallowing
Swallowing after anterior cervical discectomy and fusion
Bony fusion rates post anterior cervical discectomy and fusion
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 200
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: Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Cervical spondylosis requiring surgical treatment at 2 or more motion segments
* Ventrally - approachable vertebral levels

Exclusion Criteria:

* Minors (under 18 years old)
* Pregnant women
* Patients currently taking steroids
* Patients requiring surgical treatment at only one segment
* Comatose or incapacitated patients who cannot consent to participate
* Wards of the state
* Persons with an allergy to dexamethasone or related drugs
* Persons employed at Albany Medical Center

Primary outcomes:
measure: subjects will demonstrate good bony fusion
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
citation: Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
Clinical trial NCT01966861: Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
Official title: Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Respiratory Failure
Keywords: mechanical ventilation
weaning
acute respiratory failure
weaning failure
lung ultrasound
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Hospital Sirio-Libanes
name: University of Sao Paulo
name: Hospital Israelita Albert Einstein
First posted: 2013-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated \>48h

Exclusion Criteria:

* Moderate/Severe COPD
* Spinal cord lesion
* Neuromuscular disease (previous)
* Lung fibrosis
* Tracheostomy
* Heart failure (EF\<50%)
* Lung/pleural cancer
* inadequate "window"for LUS

Primary outcomes:
measure: Respiratory distress requiring re-intubation or non-invasive ventilation
timeFrame: 48hours
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days
measure: Hospital Mortality
timeFrame: Hospital death/discharge (up to 60 days)
measure: Adverse events
timeFrame: 48h
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'OR Institute for Research and Education
Study officials:
affiliation: D'Or Institute for Research and Education
name: Jorge IF Salluh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Luiz M Malbouisson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Fabiola Prior, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital da Bahia
name: Julio Neves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris University
name: Jean-Jacques Rouby, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02191761: Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Official title: Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Gastric Cancer
Hepatic Cancer
Pancreatic Cancer
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 13
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 an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
* Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy
* Subjects must meet certain laboratory criteria
* Expected survival \> 3months
* Subjects must have no uncontrolled intercurrent illness

Exclusion Criteria:

* Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method
* Subjects with significant cardiac issues
* Subjects using certain medications
* Subjects with certain medical conditions
* Subjects with brain metastasis
* Subjects who have recently been enrolled in other experimental clinical trials of investigational agents

Primary outcomes:
measure: Determine the MTD
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
timeFrame: 28 days
measure: Area under the plasma concentration (AUC) Versus Time Curve of SM04755
timeFrame: 30 days
measure: Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 8 weeks
measure: Maximum Observed Plasma Concentration (Cmax) of SM04755
timeFrame: 30 Days
measure: Half Life of SM04755
timeFrame: 30 Days
measure: Volume of Distribution of SM04755
timeFrame: 30 Days
measure: Time to maximum plasma concentration
timeFrame: 30 Days
measure: Accumulation ratio of SM04755
timeFrame: 30 Days
measure: Total Clearance of SM04755 after oral administration
timeFrame: 30 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Houston
country: United States
state: Texas
Study officials:
References: