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| Name | Class |
|---|---|
| Womack Army Medical Center | FED |
| Tripler Army Medical Center | FED |
| Landstuhl Regional Medical Center | FED |
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This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5) clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness study.The acceptability study is described in a separate entry.
Study intervention will be administered at week 0 and at week 2. Injections will be performed under ultrasound visualization. The study medication will be either 7-10 mL 0.5% ropivacaine injected ventral to the right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia at the level of the C6 anterior tubercle (landmarks for the stellate ganglion) (active study medication) or 1-2 mL preservative free normal saline injected anterolateral to the anterior tubercle of C6 (sham procedure). The participant will not be informed which treatment he or she has received and the interaction of the participant and treating physician will be scripted as much as possible. Following the intervention, the treating physician should have no further contact with the participant except as required for participant safety.
Participants will be evaluated for posttraumatic stress disorder (PTSD) symptomatology prior to week 0 and at 8 weeks using the Diagnostic and Statistical Manual (DSM-5) Clinician-Administered PTSD Scale (CAPS-5). They will complete the PTSD Checklist for DSM-5 (PCL-5), the PTSD Checklist - Civilian Version (PCL-C), and the Mini-international Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 0, 2, 4, 6, and 8 weeks; they also will complete the M.I.N.I.-Plus items at screening. The 12 item short form survey (SF-12), generalized anxiety disorder 7-item (GAD-7), patient health questionnaire (PHQ-9), K6, Alcohol Use Disorder Identification Test (AUDIT-C/AUDIT), and a short pain scale will be completed at weeks 0, 4, and 8.
Data collected at baseline and 8 weeks will be the primary focus of data analysis. Data collected at other time points will be analyzed as appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block (SGB) | Active Comparator | 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). |
|
| Sham Treatment | Sham Comparator | 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 0.5% ropivacaine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Score (CAPS-5) TSSS | ≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD). | Baseline, 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist (PCL-5) | to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology. | Baseline, 8-weeks |
| PTSD Checklist Civilian (PCL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center (TAMC) | Honolulu | Hawaii | 96859 | United States | ||
| Womack Army Medical Center (WAMC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31693083 | Result | Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. | |
| 38811568 |
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113 participants were randomized to treatment/sham and underwent the study procedure at Week 0 and Week 2.
123 participants screened eligible and completed the baseline CAPS-5
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| ID | Title | Description |
|---|---|---|
| FG000 | Stellate Ganglion Block (SGB) | 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine |
| FG001 | Sham Treatment | 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stellate Ganglion Block (SGB) | 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Administered PTSD Score (CAPS-5) TSSS | ≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD). | Multiple imputation performed for missing data; Mean change - Adjusted for site and baseline CAPS TSSS; adjusted mean reduction in TSSS from baseline to week 8 by treatment group from per-protocol analysis and secondary analysis among those who fulfilled CAPS 5 diagnostic criteria for PTSD at baseline were consistent with those from ITT analyses | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
Adverse event data was collected for eight weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stellate Ganglion Block (SGB) | 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary irritation of larynx which resulted in coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Treating physicians unblinded; Horner syndrome noticeable; specific population re psychotropic usage, administrative evaluations, TBI history; overall PTSD symptom severity low-moderate; a number of participants still fulfil PTSD criteria at 8 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristine L. Rae Olmsted, MSPH | RTI International | 919-541-8035 | krolmsted@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2018 | Mar 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2018 | Mar 3, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000098647 | Generalized Anxiety Disorder |
| D003863 | Depression |
| D000428 | Alcohol Drinking |
| D010146 | Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Participants will be centrally randomized to 2:1 active:sham SGB and will be evaluated at Womack Army Medical Center in North Carolina, Tripler Army Medical Center in Hawaii, and Landstuhl Regional Medical Center in Germany. Randomization will be stratified by site so that each will have a 2:1 active:sham ratio. The target population includes active-duty service members and study duration is 10 weeks in the clinical effectiveness trial for which an enrollment of 240 participants is planned.
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| Sham treatment | Drug | preservative-free normal saline |
|
|
to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology
| Baseline, 8-weeks |
| Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers "yes" to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system. | Baseline, 8-weeks |
| Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females. | Baseline, 8-weeks |
| Kessler Psychiatric Distress Scale (K6) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population. | Baseline, 8-weeks |
| The Patient Health Questionnaire (PHQ-9) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology. | Baseline, 8-weeks |
| Generalized Anxiety Disorder 7-item Survey (GAD-7) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology. | Baseline, 8-weeks |
| 12-item Short Form Survey (SF-12) of Physical Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points. | Baseline, 8-weeks |
| Short Pain Scale | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain. | Baseline, 8-weeks |
| Current Medications | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected. | Baseline, 8-weeks |
| 12 Item Short Form Survey (SF-12) of Mental Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points. | Baseline, 8-weeks |
| Fort Bragg |
| North Carolina |
| 28310 |
| United States |
| Landstuhl Regional Medical Center (LRMC) | Landstuhl | 66849 | Germany |
| Derived |
| Blakey SM, Rae Olmsted KL, Hirsch S, Asman K, Wallace D, Olmsted MG, Vandermaas-Peeler R, Karg RS, Walters BB. Differential posttraumatic stress disorder symptom cluster response to stellate ganglion block: secondary analysis of a randomized controlled trial. Transl Psychiatry. 2024 May 29;14(1):223. doi: 10.1038/s41398-024-02926-8. |
| BG001 |
| Sham Treatment |
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Military Rank | Count of Participants | Participants |
|
| Met CAPS-5 Criteria for PTSD | The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD). | Count of Participants | Participants |
|
| OG000 | Stellate Ganglion Block (SGB) | 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine |
| OG001 | Sham Treatment | 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline |
|
|
| Secondary | PTSD Checklist (PCL-5) | to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | PTSD Checklist Civilian (PCL-C) | to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers "yes" to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system. | Posted | Median | Full Range | number of events | Baseline, 8-weeks |
|
|
|
| Secondary | Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) | to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Kessler Psychiatric Distress Scale (K6) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | The Patient Health Questionnaire (PHQ-9) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Generalized Anxiety Disorder 7-item Survey (GAD-7) | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | 12-item Short Form Survey (SF-12) of Physical Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Short Pain Scale | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain. | [*] Analysis Population Description Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Current Medications | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected. | Posted | Median | Full Range | Medications | Baseline, 8-weeks |
|
|
|
| Secondary | 12 Item Short Form Survey (SF-12) of Mental Functioning | to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points. | Adjusted for site, gender, age, visit, and interaction between visit and treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-weeks |
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| 0 |
| 74 |
| 0 |
| 74 |
| 5 |
| 74 |
| EG001 | Sham Treatment | 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline | 0 | 39 | 0 | 39 | 1 | 39 |
| Pain and redness at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vasovagal syncope with insertion of the IV | Nervous system disorders | Systematic Assessment |
|
| Detection of nodule or cyst (< 1 cm) in thyroid gland | Endocrine disorders | Systematic Assessment |
|
| Self-resolving episode of bradycardia (30-second duration; minimum heart rate of 32) | Cardiac disorders | Systematic Assessment |
|
| Report of mild, relative increase in pre-existing right tinnitus | Nervous system disorders | Systematic Assessment |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |