louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02335060: N-acetylcysteine Effects on Tetrahydrocannabinol
Official title: Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: cannabis
Marijuana
THC
N-acetylcysteine
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 5
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 overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.


Eligibility criteria: Inclusion Criteria:

* Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

* Cannabis Naive
* Individuals with a documented allergy to N-acetylcysteine

Primary outcomes:
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: -30 minutes from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +15 minutes from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +90 minutes from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +240 minutes from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: -60 minutes from administration of THC
Secondary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale (CADSS)
timeFrame: -60min, -30min, +15min, +90min, +240min from administration of THC
measure: Visual Analog Scale (VAS)
timeFrame: -60min, -30min, +15min, +90min, +240min from administration of THC
measure: Cognitive Test Battery
timeFrame: +20min from administration of THC
measure: Hopkins Verbal Learning Test (HVLT)
timeFrame: +20min from administration of THC
measure: Psychotomimetic States Inventory (PSI)
timeFrame: -60min, -30min, +240min from administration of THC
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University Medical School
name: Mohini Ranganathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01785160: Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir
Official title: Investigation of Faldaprevir Effect on Steady State Pharmacokinetics of Raltegravir in Healthy Male and Female Volunteers (an Open-label Trial With Two Periods in a Fixed Sequence)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC( Tau,ss)
timeFrame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration
measure: Cmax ,ss
timeFrame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: 1220.65.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01396460: Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
Official title: Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: respiratory quotient
fat oxidation
morbid obesity
bariatric
Bariatric Surgery
Lead sponsor: Gastrocirurgia, Brazil
Sponsor class: OTHER
First posted: 2011-07-18
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Bariatric post operative population

Brief summary: Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period.

Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients.

The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.


Eligibility criteria: Inclusion Criteria (bariatric patients post-op)

* With more than 1 year after surgery
* Consent given to participate

Exclusion Criteria:

* Pregnant women
* Malnourished patients (anemia)
* Tiroid disorders without treatment

Primary outcomes:
measure: Diet Induced Thermogenesis
timeFrame: 20min after standard meal
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Gastrocirurgia de Brasilia
state: Distrito Federal
Study officials:
References:
Clinical trial NCT03670160: Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Official title: Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: University of Tennessee Medical Center
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).


Eligibility criteria: Inclusion Criteria:

* Infants greater than or equal to 35 weeks gestation age
* Admitted to the neonatal intensive care unit
* Failed monotherapy with morphine sulfate therapy

Exclusion Criteria:

* Neonatal abstinence syndrome due to iatrogenic causes
* Unable to take oral medications at any point during their treatment
* Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment

Primary outcomes:
measure: Time From Initiation of Adjunctive Therapy Until Hospital Discharge
timeFrame: From date of randomization until hospital discharge, up to 4 months
Secondary outcomes:
measure: Length of Stay
timeFrame: From date of randomization until hospital discharge, up to 4 months
measure: Length of Oral Morphine Sulfate Therapy
timeFrame: From date of randomization until hospital discharge, up to 4 months
measure: Number of Patients Requiring Triple Therapy
timeFrame: From date of randomization until hospital discharge, up to 4 months
measure: Readmission Rate
timeFrame: From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee Medical Center
name: Carrie Brusseau, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759460: Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
Official title: An Exploratory Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Metabolic Effect of up to 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on metabolic parameters and syndrome in patients with schizophrenia.

Detailed description: The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome.

Patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia
* Participation in 11286 study
* Capable of completing all study-related activities for the duration of the study

Primary outcomes:
measure: Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04560660: Ketamine-enhanced Prolonged Exposure Therapy in PTSD
Official title: Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: PTSD
Keywords: Post-traumatic Stress Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to one of two parallel treatment conditions: 1) adjunctive ketamine infusions to prolonged exposure therapy or 2) adjunctive midazolam (active placebo) infusions to prolonged exposure therapy.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.

Detailed description: In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.

Eligibility criteria: Inclusion Criteria:

* male or female Veterans between the ages of 18 and 75 years
* diagnosis of PTSD
* ability to provide written informed consent

Exclusion Criteria:

* females who are currently pregnant or breastfeeding
* current high risk for suicide
* history of moderate/severe head injury
* history of psychosis
* current episode of mania/hypomania
* severe substance and/or alcohol use disorder in the last 6 months

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Paulo R Shiroma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705260: Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
Official title: Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Twine Clinical Consulting
First posted: 2018-10-15
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).


Eligibility criteria: Inclusion Criteria:

* Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
* Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
* HbA1C \>8 for the high-risk sub-cohort

Exclusion Criteria:

* Individuals for whom tight control (ie A1C \< 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
* Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
* Women who are pregnant or breast feeding
* Individuals who had previous bariatric surgery

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 1 year
Secondary outcomes:
measure: Weight Change
timeFrame: baseline to 1 year
measure: Change in diabetes medication requirements
timeFrame: baseline to 1 year
measure: Change in percentage of time glucose is out of range
timeFrame: baseline to 1 year
measure: Blood Pressure
timeFrame: 1 year
measure: Change in rate of Micro-vascular complications
timeFrame: Baseline to 1 Year
measure: Change in rate of symptomatic hypoglycemia requiring medical intervention
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Chelsea
country: United States
facility: Chelsea Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Caroline Richardson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06419660: A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood
Official title: The Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose BI 3000202 in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 3000202 in plasma.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to 4 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 4 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT01869660: Shared Decision Making for Patients With First-admission Schizophrenia
Official title: Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: First hospitalization
Lead sponsor: Yokohama City University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.


Eligibility criteria: Inclusion Criteria:

* Admitted to an acute care psychiatric ward.
* Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
* Aged 16 to 65 years old at admission
* No prior experience of psychiatric admission (first-admission)

Exclusion Criteria:

* Diagnosed with moderate to severe mental retardation
* Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
* Having poor Japanese language skill
* Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Primary outcomes:
measure: Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Within 7days before the date of discharge
Secondary outcomes:
measure: Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)
timeFrame: Within 7days before the date of discharge
measure: Treatment continuation as measured by the rate of outpatient attendance during the 30 days
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Numazu
country: Japan
facility: Numazu Chuou Hospital
state: Shizuoka
Study officials:
affiliation: Department of Psychiatry, Yokohama City University School of Medical
name: Yoshio Hirayasu, PhD
role: STUDY_CHAIR
References:
citation: Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial. BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.
citation: Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial. BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.
Clinical trial NCT01798160: Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Official title: Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 24
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: Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* HCC, proven by histology or according to EASL criteria
* Intermediate stage HCC (stage B according to BCLC)
* At least one measurable lesion in magnetic resonance imaging (MRI)
* Tumor load ≤ 50%
* preserved liver function (Child Pugh A and B)

Exclusion Criteria:

* Patients feasible for curative treatment (e.g. resection or local ablation)
* Previous TACE or SIRT
* Chemotherapy during the last 4 weeks
* Child Pugh stage C
* BCLC stage D
* ECOG Performance Status \>0
* Tumor involvement \>50% of the liver
* Extrahepatic tumor
* Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
* Esophageal bleeding during the last 3 months
* Hepatic encephalopathy
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Infiltration or occlusion of the portal vein
* Hepatofugal blood flow in the portal vein
* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
* Contraindications against angiography
* Gravidity

Primary outcomes:
measure: Progression-free-Survival
timeFrame: up to three years
measure: Overall-Survival
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: