louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04984642: Plasma, Urine and Tear Omics Changes in Different Diets
Official title: Plasma, Urine and Tear Omics Changes Based on Protein and Metabonomics Technology in Different Diets and Screening of Healthy Diet Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study plans to start in July 2021, and it is expected that 20 healthy people (aged 18-70 years old, BMI 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. Participants will be enrolled in the group through the screening and plan to take regular diet, OGTT, high-fat diet, low-calorie diet and ketogenic diet within 5 weeks. The proteomics and metabolomics indicators of tear, plasma, and urine specimens will be measured at 5 time points at baseline, 30 minutes, 1 hour, 2 hours, and 3 hours for each diet. The correlation of proteomics and metabolomics indicators with classic laboratory parameters (BMI, HDL, LDL, cholesterol, triglyceride levels, and insulin resistance (HOMA-IR)) will be analyzed.


Eligibility criteria: Inclusion Criteria:

1. Healthy individuals aged 20-70 years, with a body mass index (BMI) of 18.5-40 kg/m².
2. No known chronic medical conditions.
3. Willingness to comply with study requirements and adhere to the intervention protocol.

Exclusion Criteria:

1. Presence of significant medical conditions or chronic diseases.
2. Diagnosis of diabetes mellitus or prediabetes.
3. Triglyceride level ≥4 mmol/L.
4. Blood pressure ≥160/100 mmHg or presence of malignant hypertension.
5. History of an eating disorder.
6. Previous bariatric surgery.
7. Severe gastrointestinal diseases.
8. History of diarrhea within the past two weeks.
9. Special dietary requirements or known food allergies.
10. Pregnancy or breastfeeding.

Primary outcomes:
measure: Proteomics and metabolomics changes after diet intervention
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06854406: A Study of Varenicline in the Treatment of Visceral Sensation
Official title: Varenicline in the Treatment of Visceral Sensation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: IBS
pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: To evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain.


Eligibility criteria: Inclusion Criteria:

1. Participants will be 18-70 years of age
2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\]

Exclusion Criteria:

1. Diagnosis of moderate-severe depression as per HADS\&gt;8
2. Alcohol or illicit substance dependence or abuse in the past 12 months
3. Dementia, unprovoked seizure history, seizure disorder
4. Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form)
5. Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks
6. Medically unstable
7. Severe hepatic or renal impairment, such as baseline AST or ALT \&gt;2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \&lt;15 mL/min
8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.

Primary outcomes:
measure: Rectal compliance
timeFrame: Comparison on day 8 of vareniciline treatment compared to baseline
measure: Rectal sensation thresholds during ascending method of limits
timeFrame: Comparison on day 8 of vareniciline treatment compared to baseline
measure: Rectal sensation ratings during random order, graded phasic distensions
timeFrame: Comparison on day 8 of vareniciline treatment compared to baseline
Secondary outcomes:
measure: Safety/adverse effects
timeFrame: 8 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000206: Clinical Rescue Protocol - 2
Official title: Clinical Rescue Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: Opioid
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Retention
measure: Opiate use
measure: Opiate craving
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ling W, Shoptaw S, Wesson D, Rawson RA, Compton M, Klett CJ. Treatment effectiveness score as an outcome measure in clinical trials. NIDA Res Monogr. 1997;175:208-20. No abstract available.
Clinical trial NCT01217606: Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 185
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 will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

* Required chronic use of ocular medications during the study other than study medication
* Use of any corticosteroids within 30 days
* History of any traumatic eye surgeries
* Cataract surgery in the past 6 months
* Anticipated wearing of contact lenses during the study

Primary outcomes:
measure: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12
measure: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12
Other outcomes:
Locations:
city: São Paulo
country: Brazil
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.
Clinical trial NCT00663806: A Phase IV Study of Cipro XR in Uncomplicated UTI
Official title: EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: UTI
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 7614
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.


Eligibility criteria: Inclusion Criteria:

* Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
* Positive leukocyte esterase (\>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
* Willing to give written consent.

Exclusion Criteria:

* Pregnant or nursing
* Complicated UTI
* Allergy to Cipro XR

Primary outcomes:
measure: To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.
timeFrame: 3-10 days after start of therapy
Secondary outcomes:
measure: To examine the difference between physician and patient perceptions of the symptoms of uUTI.
timeFrame: At baseline visit pre-therapy
measure: To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.
timeFrame: 1-3 days after end of therapy for efficacy and up to 30 days for safety
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00935506: Ex Vivo Human Thrombosis Chamber Study
Official title: Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose of study is to evaluate a thrombosis chamber model


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects
* BMI 18-30 kg/m²
* Male ages 18-45

Exclusion Criteria:

* Significant acute or chronic illness
* History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age
* Easy bruising
* Smoking within 3 months prior to Day 1

Primary outcomes:
measure: Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
timeFrame: Period 2, Day 8
Secondary outcomes:
measure: Assess variability of thrombosis chamber measurements
timeFrame: Period 1 and Period 2
measure: Assess relationship between platelet aggregation and thrombus formation
timeFrame: Period 1 and Period 2
measure: Safety and tolerability of multiple doses clopidogrel and aspirin
timeFrame: From Day 1 through Study Discharge
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Mds Pharma Services
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02901106: Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
Official title: Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting
Dimethyl fumarate
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-15
Enrollment: 11
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 dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.


Eligibility criteria: Inclusion Criteria:

* patient 18 years old and more
* with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP)
* for which treatment with dimethyl-fumarate has been prescribed
* followed at the Rothschild Foundation in the Neurology Department
* having given written consent to participation in the study

Exclusion Criteria:

* pregnant or breastfeeding woman
* patient with a measure of legal protection
* subject unaffiliated insurance

Primary outcomes:
measure: Number of patients with a relapse and/or progressive worsening of disease (EDSS score)
timeFrame: After one year of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT00804206: Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
Official title: Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Macular Edema
Keywords: Intravitreal injection of Bevacizumab
Visual acuity
central retinal thickness
color studies, Farnsworth-Munsell
electroretinogram studies
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.


Eligibility criteria: Inclusion Criteria:

* Patients with proliferative diabetic retinopathy
* patients with macular edema

Exclusion Criteria:

* patients with previous treatments
* patients with ocular surgeries

Primary outcomes:
measure: Central macular thickness
timeFrame: baseline, 10 days, 52 days, 85 days
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: baseline, 10 days, 52 days, 85 days
Other outcomes:
Locations:
city: México
country: Mexico
facility: Asociación para Evitar la Ceguera en México
Study officials:
References:
Clinical trial NCT05846906: Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
Official title: Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility, Female
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.

Detailed description: One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.

Eligibility criteria: Inclusion Criteria:

* ages of 18 to 40
* patent tubes
* unexplained infertility
* regular menstrual cycle
* husband with normal sperm parameters

Exclusion Criteria:

* hypotension
* cardiovascular, renal and hepatic diseases
* uncontrolled diabetes mellitus
* anovulatory infertility
* abnormal thyroid functions
* ovarian cysts
* patients taking nitrates
* pelvic adhesions
* abnormal hormonal profile.
* hyperprolactinemia
* multiple uterine fibroids
* adenomyosis and endometriosis suspicion

Primary outcomes:
measure: Pregnancy rate
timeFrame: at the end of the cycle (28 days)
Secondary outcomes:
measure: endometrial thickness
timeFrame: 1 month
measure: ovulation rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: STUDY_DIRECTOR
References:
Clinical trial NCT04764006: Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study
Official title: A Single Arm, Open-label, Single Center Phase II Study of Surufatinib Combined With PD-1 in Patients With Advanced MSS-Type Colorectal Cancer Treated With Standard First-line Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.


Eligibility criteria: Inclusion Criteria:

1. For inclusion in study, patient must provide a written informed consent.
2. Male or female, age18-75 years.
3. Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma .
4. The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
6. Life expectancy \> 12 weeks.
7. Have measurable disease based on RECIST 1.1.

Exclusion Criteria:

1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous.
2. Prior receipt of Surufatinib.
3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy).
4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing.
5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 12 months
measure: Overall survival time
timeFrame: up to 36 months
measure: Assess the anti-tumor activity:DCR
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: China, Fujian
state: Fujian
Study officials:
References: