anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Metoclopramide
Trial phase: Phase 3
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime for 4 weeks

Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide
Eligibility criteria:
Inclusion Criteria:

Non pregnant, non lactating female subjects between the ages of 18 and 75 years
Willingness and ability to give written informed consent
The ability to read, understand and speak English
Prior diagnosis of Type 1 or Type 2 diabetes
Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
Subjects of childbearing potential must agree to use contraception
Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study

Exclusion Criteria:

Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
A history of, or physical findings suggestive of, tardive dyskinesia
A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
A history of allergy to any of the ingredients in the study drug formulation
A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS)
Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening
Hemoglobin A1c >11.5% at screening
Subjects who are trying to conceive, are pregnant, or are lactating
Intervention: Metoclopramide
Trial phase: Phase 3
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks

Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Eligibility criteria:
Inclusion Criteria:

Male subjects between the ages of 18 and 75 years
Willingness and ability to give written informed consent
The ability to read, understand and speak English
Prior diagnosis of Type 1 or Type 2 diabetes
Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study

Exclusion Criteria:

Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
A history of, or physical findings suggestive of, tardive dyskinesia
A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening
Hemoglobin A1c >11.5% at screening
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.

Tranexamic Acid: 1 gram IV over 10 minutes
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I or II
aged 18-50 years
singleton vertex pregnancy
scheduled elective cesarean delivery (with or without prior labor) with a planned pfannenstiel incision

Exclusion Criteria:

allergy to tranexamic acid
history of inherited or acquired thrombophilia
history of deep vein thrombosis or pulmonary embolism, or use of anticoagulant medication.
preeclampsia, hemolysis, elevated liver enzymes, low platelet syndrome
seizure disorder
Intervention: Betamethasone
Trial phase: Not Applicable
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Dexamethasone 12 mg, 2 doses, 12 hours apart.

Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Eligibility criteria:
Inclusion Criteria:

Currently 34 weeks pregnant or within 6 weeks postpartum
At least 18 years of age
Singleton or twin gestation
Patient or family sign informed consent
Diagnosis of eclampsia
Able to obtain MRI scanning within 24hours of hosp admit and/or seizure

Exclusion Criteria:

Neither pregnant nor within first 6 weeks postpartum
Patient or family unable to sign informed consent
Less than 18 years of age
Triplet or higher order gestation
Unable to obtain MRI scanning within 24 hours of hospital admission (
Diagnosis of cerebral hemorrhage
Patient in whom MRI is contraindicated
Intervention: Betamethasone
Trial phase: Not Applicable
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Placebo, 2 doses, 12 hours apart
Eligibility criteria:
Inclusion Criteria:

Currently 34 weeks pregnant or within 6 weeks postpartum
At least 18 years of age
Singleton or twin gestation
Patient or family sign informed consent
Diagnosis of eclampsia
Able to obtain MRI scanning within 24hours of hosp admit and/or seizure

Exclusion Criteria:

Neither pregnant nor within first 6 weeks postpartum
Patient or family unable to sign informed consent
Less than 18 years of age
Triplet or higher order gestation
Unable to obtain MRI scanning within 24 hours of hospital admission (
Diagnosis of cerebral hemorrhage
Patient in whom MRI is contraindicated
Intervention: Malathion
Trial phase: Not Applicable
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 52
Group description: Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.

Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete.
Eligibility criteria:
Inclusion Criteria:

Children 2-12 months of age presenting to Emergency Department
Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist

Exclusion Criteria:

Previous history of wheezing
Known heart or lung disease
Premature birth defined as birth before 37 weeks gestation
Immunosuppression or immunodeficiency
Treatment with corticosteroids in the previous 48 hours
Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
Oxygen saturation <85% on room air at the time of recruitment
Intervention: Miglustat
Trial phase: Phase 4
ATC code: A16AX06
SMILES: CCCCN1C[C@H](O)[C@@H](O)[C@@H](O)[C@H]1CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet, and daily treatment with orally-administered miglustat, for the duration of the 60-month study.

miglustat: The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.

Ketogenic Diet: The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study.
Eligibility criteria:
Inclusion Criteria:

Subjects must have a documented infantile or juvenile gangliosidosis disease.
Age: 17 years or less at time of enrollment
Subjects and their caregivers must be willing to work with a ketogenic diet team for management of the subject's ketogenic diet.

Exclusion Criteria:

A desire to not participate
Patients who are older than 17 years will not be enrolled in this study.
Children with severe renal impairment will not be enrolled in this study.
Post-pubertal females who are pregnant, or who are unwilling to use highly-effective methods to prevent pregnancy, will be excluded from this study.
Breast-feeding females will be excluded from this study.
Subjects who have an allergy to miglustat or any of the components within the drug product will be excluded from this study.
Intervention: Tetracosactide
Trial phase: Not Applicable
ATC code: H01AA02
SMILES: CSCC[C@H](NC(=O)[C@H](CO)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@@H](N)CO)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N1CCC[C@H]1C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N1CCC[C@H]1C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.

ACTHAR gel: Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18 year of age and older
RA diagnosis by American College of Rheumatology criteria
Active disease (CDAI > 10)
Have received at least are biologic agent for at least 6 months
May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
No current active infections requiring antibiotics
Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)

Exclusion Criteria:

Less than 18 years of age
Unable or unwilling to give Informed Consent
Have an active infection requiring the use of antibiotics
Women who are pregnant
Uncontrolled hypertension
Abnormal renal function
Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.

The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.

The tablets should be swallowed whole with a glass of water.

AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).
Eligibility criteria:
Inclusion Criteria:

Females must be surgically sterile or postmenopausal or using a highly effective form of birth control throughout the duration of the study
Females must have a negative urine pregnancy test at screening
Must meet the criteria for Chronic Idiopathic Urticaria (CIU) as defined by itching and hives for >3 days per week for over 6 weeks with no clear cause
CIU symptoms must have started at least 6 months prior to starting the study
Must have moderate to severe CIU, using a standardized survey, despite taking antihistamines

Exclusion Criteria

Pregnant females or females who plan to become pregnant during the study
Drug or alcohol abuse within the past 3 years
Use of any investigational drug with 30 days of the start of the study
Eczema or other skin conditions associated with itching (besides hives)
Inability to comply with follow-up procedures
Use of the following therapies in the past 30 days: hydroxychloroquine, sulfasalazine, dapsone, methotrexate, cyclophosphamide, Intravenous Immunoglobulin (IVIG), plasmapheresis, cyclosporine, oral or systemic steroids, or other monoclonal antibody therapies
Use of doxepin within the past 2 weeks
Use of either H2 antihistamines and leukotriene receptor antagonists within 7 days before starting the study (unless already on these medications for Gastroesophageal Reflux Disease (GERD), asthma or allergic rhinitis)
Inability to take diphenhydramine (Benadryl)
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks or interfere with ability to comply with study procedures.
Intervention: Dapsone
Trial phase: Phase 4
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acne vulgaris
Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

Received treatment with botulinum toxin of any serotype in the face within 6 months
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 283
Group description: Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)
Eligibility criteria:
Inclusion Criteria

Male or female
18 years of age and older
Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)
Have used opioids other than as specifically prescribed within thirty days prior to consent
Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy
In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX
Able to provide written informed consent
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study

Exclusion Criteria

Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include:

Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)
LFTs (ALT, AST) greater than 5 times upper limit of normal
Suicidal or homicidal ideation that requires immediate attention
Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent
Maintenance on methadone at doses of 30mg or greater at the time of signing consent
Presence of pain of sufficient severity as to require ongoing pain management with opioids
Pending legal action or other reasons that might prevent an individual from completing the study
If female, currently pregnant or breastfeeding, or planning on conception
Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks, emaciation)
Intervention: Buprenorphine and Naloxone
Trial phase: Phase 4
SMILES: C=CCN1CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 287
Group description: Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Eligibility criteria:
Inclusion Criteria

Male or female
18 years of age and older
Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)
Have used opioids other than as specifically prescribed within thirty days prior to consent
Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy
In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX
Able to provide written informed consent
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study

Exclusion Criteria

Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include:

Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)
LFTs (ALT, AST) greater than 5 times upper limit of normal
Suicidal or homicidal ideation that requires immediate attention
Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent
Maintenance on methadone at doses of 30mg or greater at the time of signing consent
Presence of pain of sufficient severity as to require ongoing pain management with opioids
Pending legal action or other reasons that might prevent an individual from completing the study
If female, currently pregnant or breastfeeding, or planning on conception
Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks, emaciation)
Intervention: Avanafil
Trial phase: Phase 4
ATC code: G04BE10
SMILES: COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Stendra 200 mg
Eligibility criteria:
Inclusion Criteria:

Healthy adult males 18 to 45 years of age, inclusive
Non-tobacco user for at least 6 months prior to first dose

Exclusion Criteria:

History or presence of retinal disease or any vision defects including color vision
Intraocular pressure value ≥ 22mm Hg
Resting heart rate < 45 or > 90 beats per minute (3 rechecks)
Systolic blood pressure < 90 or > 140 mm Hg or Diastolic blood pressure < 50 or >90 mm Hg (3 rechecks)
Initiation or change in dose of any α-blockers 14 days prior to randomization