louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01329692: Early Intervention for Morbidly Obese Patients After Roux-en-Y Gastric Bypass (RYGB) Surgery
Official title: Early Intervention in Patients With Predicted Poor Long-term Outcome Following Laparoscopic Roux-en-Y Gastric Bypass: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: RYGB
Intervention
follow-up
standard-of-care
Back on Track program
poor weight loss
morbidly obese
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Purpose and objective: To identify in the early post-operative period following laparoscopic Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected fashion, and to institute intervention and assess for its efficacy.

Study activities and population group: Patients identified to have "poor weight loss" (≤ 11% of excess weight loss) at 1 month will be randomized into a control versus study group. Intervention for subjects randomized to the IV arm will be by enrollment in the Back on Track program. This is a seven-week group education, counseling, nutrition, exercise, and journaling program of the Duke Weight Loss Surgery Center designed to help postoperative bariatric surgery patients who are failing to progressively lose weight resume an expected pattern of weight loss and improved overall outcome.

Data analysis and risk/safety: Data will be collected and analyzed by the identified investigators. The goal of data analysis is to uncover any difference in the EWL of subjects who underwent intervention for falling in the lowest EWL quartile when compared with those who did not undergo intervention, and determine the statistical significance of any such difference. There are no physical risks associated with this study. There is, however, the potential risk of loss of confidentiality. Every effort will be made to keep your information confidential.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Patient is scheduled and consented for laparoscopic Roux-en-Y gastric bypass as part of their routine medical care

Exclusion Criteria:

* Younger than Age 18 years
* Patient is disabled and unable to participate in an exercise program

Primary outcomes:
measure: First quartile excess weight loss(0-11% EWL)at one month predicted first quartile EWL at 12-month and 36-month follow-up.
timeFrame: 1-7 week intervention, 3,6, and 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT04423692: Knowledge About Covid-19 Infection in Pregnant Women
Official title: Knowledge About Covid-19 Infection in Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Infection
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at any GA

Brief summary: Covid 19 is a pandemic infection developed in late 2019

Detailed description: It developed in China Then spread worl wide

Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* non pregnant women

Primary outcomes:
measure: The number of pregnant women who have knowledge about covid-19
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
References:
Clinical trial NCT04306692: Myo-inositol Versus Clomiphene Citrate in PCOS
Official title: Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ovulation Induction
Polycystic Ovary Syndrome
Clomiphene
Inositol
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Gedeon Richter Plc.
name: University Hospital, Antwerp
name: AZ Jan Palfijn Gent
name: Our Lady of Lourdes Hospital Waregem
First posted: 2020-03-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.


Eligibility criteria: Inclusion Criteria:

* Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe \>8 MHz) in both ovaries.
* A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
* Use of own or donor sperm.

Exclusion Criteria:

* Tubal factors
* Uterine factors
* Endometriosis AFS score 3 or 4
* Moderate to severe male factor (as defined by each local center)
* BMI \> 35

Primary outcomes:
measure: Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.
timeFrame: At 7 - 8 gestational weeks
Secondary outcomes:
measure: The number of potential adverse events
timeFrame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
measure: The occurrence of ovulation
timeFrame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
measure: The number of cancelled treatment cycles
timeFrame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
measure: The number of multiple pregnancies
timeFrame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
References:
Clinical trial NCT02316392: Imaging and Understanding BOS in Lung Transplantation
Official title: Imaging and Understanding BOS in Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans Syndrome
Keywords: Helium
MRI
Lung transplantation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have had or are scheduled for lung transplant

Brief summary: This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

Detailed description: This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 Magnetic Resonance Imaging and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.

Eligibility criteria: Inclusion Criteria:

* Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
* Male or female
* 0 to 25 years of age.

Exclusion Criteria:

* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
* Inability to perform 10 second breath hold for 3He MRI scan
* Bleeding disorders

Primary outcomes:
measure: Analysis of MRI imaging to detect BOS compared to biopsy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: Jason Woods, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03951792: Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Official title: Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Colon
Gastrointestinal Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2019-05-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN.

Brief summary: Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

Detailed description: The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer.

Study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing bowel resection by any standard surgical approach.

Exclusion Criteria:

* Female that are pregnant
* Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.
* Currently receiving or have received chemotherapy in the past 2 weeks.

Primary outcomes:
measure: DNA/RNA Biomarkers
timeFrame: 5 years
measure: Microbial 16S rDNA Biomarkers
timeFrame: 5 years
Secondary outcomes:
measure: Protein Measurements
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas L. Chia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646592: Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
Official title: Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anesthesia
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.


Eligibility criteria: Inclusion Criteria:

* Elective surgery under general anesthesia
* Written informed consent

Exclusion Criteria:

* Chronic pain
* Preoperative analgesic drug
* Neurologic disease
* Ophtalmic disease

Primary outcomes:
measure: Change between Pupillary Pain Index before and after alfentanil bolus
timeFrame: Five minutes before incision and just before incision. Each measure = 20 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: University Hospital Armand Trousseau
name: Isabelle Constant, PHD
role: STUDY_DIRECTOR
References:
citation: Sabourdin N, Diarra C, Wolk R, Piat V, Louvet N, Constant I. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019 Mar;128(3):467-474. doi: 10.1213/ANE.0000000000003681.
Clinical trial NCT02806492: Parameters of Cerebral Perfusion
Official title: Blood Pressure or Cardiac Output - the Influence on Cerebral Perfusion During Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Perfusion
Cerebral Oxygenation
Cardiopulmonary Bypass
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Undergoing cardiopulmonary bypass for CABG a
* having an appropriate temporal bone window for reliable TCD monitoring
* needing pharmacological intervention because of hypotension before going on CPB.

Exclusion Criteria:

* requiring hypothermia during surgery
* requiring emergency surgery
* contraindication for phenylephrine,
* having known brain pathology (e.g. Cerebral Vascular Accident (CVA) or increased intracranial pressure
* having a history of severe carotid artery stenosis.

Primary outcomes:
measure: regional cerebral oxygen saturation
timeFrame: During surgery
measure: mean velocity of blood flow of the middle cerebral artery
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
Clinical trial NCT01401192: Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
Official title: A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: thymidylate synthase
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 304
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: This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed nonsquamous NSCLC
* Stage IIIb, IV or recurrent NSCLC
* Age ≥ 18years
* ECOG performance status of 0 to 1
* Known TS immunohistochemical analysis data
* At least one measurable lesion by RECIST 1.1
* No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
* Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
* At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
* Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

* Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
* Patients with post-obstructive pneumonia or uncontrolled serious infection

Primary outcomes:
measure: predictive value of TS expression
timeFrame: 12 months
Secondary outcomes:
measure: response rate
timeFrame: 12 months
measure: response rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Myung-Ju Ahn, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.
Clinical trial NCT02841592: Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.


Eligibility criteria: Inclusion Criteria:

* Age \>17

Exclusion Criteria:

* Pregnant
* Any facial hair more than stubble that might impede a mask seal

Primary outcomes:
measure: Fraction of expired oxygen
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
citation: Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.
Clinical trial NCT04908592: Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia
Official title: Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. The main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the Bezold Jarish reflex (BJR) that elicits a triad of bradycardia, vasodilatation and further hypotension. BJR is elicited by activation of 5-HT3 receptors within the intracardiac vagal nerve endings.
* Glucocorticoids in general inhibit 5-HT3 expression and dexamethasone was found to decrease the level of 5-HT3 in the cerebral cortex and hippocampus in developing rats. So, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered preoperatively.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
2. Elective surgery under general anesthesia.

Exclusion Criteria:

1. Emergency surgeries.
2. Ischemic heart disease.
3. Peptic ulcer \& active infection.
4. Psychiatric disorder.
5. Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).

Primary outcomes:
measure: The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT05039892: Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma
Official title: An Open-label, Single Arm, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Alterations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cholangiocarcinoma,Adult
Lead sponsor: 3D Medicines
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 50
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: The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed cholangiocarcinoma.
2. Documented disease progression following at least one previous systemic cancer therapy
3. Tumor assessment for FGF/FGFR gene alteration status.
4. Have measurable disease according to RECIST v1.1
5. ECOG Performance Status ≤ 2
6. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Previously received selective FGFR inhibitor therapy.
2. History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
3. Have any of the following eye diseases/conditions: 1) history of retinal pigment epithelial detachment (RPED); 2) history of laser treatment or intraocular injection for macular degeneration; 3) history of dry or wet age-related macular degeneration; 4) history of retinal vein occlusion (RVO); 5) history of retinal degenerative diseases; 6) history of chorioretinal lesions..
4. Received CYP3A4 and/or CYP2C8 strong inhibitors or CYP3A4 strong inducers within 14 days prior to the first dose and subject who need to continue using these drugs.

Primary outcomes:
measure: ORR
timeFrame: 24 months
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: 3D185 Plasma concentration
timeFrame: 24 months
measure: Serum phosphate levels
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: