anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Diacerein
Trial phase: Phase 2
ATC code: M01AX21
SMILES: CC(=O)Oc1cccc2c1C(=O)c1c(OC(C)=O)cc(C(=O)O)cc1C2=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Subjects with active lesions as determined Investigator's clinical assessment, will apply diacerein 1% ointment once-daily, to their EBS lesions for 8 weeks. Following an off treatment period of 8 weeks or more, subjects may enter into another Treatment Period of 8 weeks. The subject's participation may range from 32 weeks to 52 weeks.
Eligibility criteria:
Key Inclusion Criteria:

The subject is capable of understanding and complying with protocol requirements.
The subject or the subject's legally acceptable representative signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any study procedures.
Subject has a documented genetic mutation consistent with EBS.
Subject has completed study CCP-020-301 or participated in study CCP-020-101.
Subject/caregiver agrees to report use of any topical therapies applied to EBS lesions
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control, for the duration of the study.
Subject is non-lactating and is not planning for pregnancy during the study period.
Subject is willing and able to follow all study instructions and to attend all study visits.

Key Exclusion Criteria:

Subject has EBS lesions to be treated that are infected
Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to Baseline Visit.
The subject was discontinued from the feeder study due to an adverse event judged to be related or possibly related to the study medication.
Subject has experienced a change in clinical status from the feeder study that puts the subject at undue risk to participate.
Intervention: ASCORBIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: The combination of vitamin C, vitamin B1, hydrocortisone :

Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days
Vitamin B1 (thiamine) 100mg every 6 hours x 4-days
Hydrocortisone 50mg every 6 hours x 4-days

vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.
Eligibility criteria:
Inclusion Criteria:

Adult patient (age ≥ 18 years)
Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

Exclusion Criteria:

Member of a protected population (pregnant, prisoner)
Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
End stage renal disease (ESRD) requiring dialysis
Known Glucose-6-Phosphate Dehydrogenase deficiency
Known Hemachromatosis
Comfort Measures Only status
Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug
Clinical indication for thiamine as determined by the clinical team providing this drug
Clinical indication for ascorbic acid as determined by the clinical team providing this drug
Known allergy to vitamin C, hydrocortisone, or thiamine
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components

Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Eligibility criteria:
Inclusion Criteria:

Adult patient (age ≥ 18 years)
Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

Exclusion Criteria:

Member of a protected population (pregnant, prisoner)
Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
End stage renal disease (ESRD) requiring dialysis
Known Glucose-6-Phosphate Dehydrogenase deficiency
Known Hemachromatosis
Comfort Measures Only status
Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug
Clinical indication for thiamine as determined by the clinical team providing this drug
Clinical indication for ascorbic acid as determined by the clinical team providing this drug
Known allergy to vitamin C, hydrocortisone, or thiamine
Intervention: Aristospan
Trial phase: Phase 3
SMILES: CC(C)(C)CC(=O)OCC(=O)C12OC(C)(C)OC1CC1C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.

Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
Eligibility criteria:
Inclusion Criteria:

Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.
Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

Exclusion Criteria:

Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
Intervention: Roflumilast
Trial phase: Phase 1 | Phase 2
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
Eligibility criteria:
Inclusion Criteria:

Adult male and female participants aged ≥18 years.
In Cohort 1, participants must have at least 25 cm^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
In Cohort 2, participants must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm^2 in size with a TPSS ≥4 (excluding the face, scalp, intertriginous areas, palms and soles).
Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
Participants agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
Participants are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.

Exclusion Criteria:

Participants with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis.
Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.
Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication.
Known allergies to excipients in ARQ-151 cream.
Participants who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.
Participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.
Participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.
Participants with a history of chronic alcohol or drug abuse in past 6 months.
History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.
Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
Participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.
Intervention: Roflumilast
Trial phase: Phase 1 | Phase 2
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
Eligibility criteria:
Inclusion Criteria:

Adult male and female participants aged ≥18 years.
In Cohort 1, participants must have at least 25 cm^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
In Cohort 2, participants must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm^2 in size with a TPSS ≥4 (excluding the face, scalp, intertriginous areas, palms and soles).
Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
Participants agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
Participants are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.

Exclusion Criteria:

Participants with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis.
Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.
Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication.
Known allergies to excipients in ARQ-151 cream.
Participants who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.
Participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.
Participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.
Participants with a history of chronic alcohol or drug abuse in past 6 months.
History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.
Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
Participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.
Intervention: Midazolam
Trial phase: Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Midazolam IV; 0.04mg/kg over 40 minutes

Midazolam: 1 single dose of IV midazolam
Eligibility criteria:
Inclusion Criteria:

Age 21-60
Clinical diagnosis of Borderline Personality Disorder
Has suicidal ideation.
Fluent in English
Has a current mental health treater, and agrees for study to communicate with treater

Exclusion Criteria:

Current suicidal intent
Med changes in last 4 weeks
Any ketamine in any context in the last one year.
Current prescription for topiramate, lamotrigine, or lithium.
Psychotic disorder in self or first-degree relative
Current substance dependence including alcohol dependence
Any history of NMDA (N-methyl-D-aspartate )-antagonist abuse
Any history of opiate abuse
History of major medical illness especially neurologic or cardiovascular condition, or any other medical contra-indication to ketamine administration at the discretion of the study MD.
Positive urine test for drugs of abuse screening on day of ketamine administration
Positive pregnancy test on day of ketamine administration
At the discretion of study staff
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: ketamine IV; 0.5 mg/kg over 40 minutes

Ketamine: 1 single dose of IV ketamine
Eligibility criteria:
Inclusion Criteria:

Age 21-60
Clinical diagnosis of Borderline Personality Disorder
Has suicidal ideation.
Fluent in English
Has a current mental health treater, and agrees for study to communicate with treater

Exclusion Criteria:

Current suicidal intent
Med changes in last 4 weeks
Any ketamine in any context in the last one year.
Current prescription for topiramate, lamotrigine, or lithium.
Psychotic disorder in self or first-degree relative
Current substance dependence including alcohol dependence
Any history of NMDA (N-methyl-D-aspartate )-antagonist abuse
Any history of opiate abuse
History of major medical illness especially neurologic or cardiovascular condition, or any other medical contra-indication to ketamine administration at the discretion of the study MD.
Positive urine test for drugs of abuse screening on day of ketamine administration
Positive pregnancy test on day of ketamine administration
At the discretion of study staff
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 2
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1181
Group description: Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate.
Eligibility criteria:
Inclusion Criteria:

Histopathological proven prostate adenocarcinoma.

Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
Karnofsky performance status of ≥ 50.
Age ≥ 18.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Current investigational therapy for prostate cancer.
Unable to lie flat, still or tolerate a PET/CT scan.
Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
Prisoner.
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice
Eligibility criteria:
Inclusion Criteria:

Read, understand, and sign the informed consent forms
Have at least 1 dental implant
Have no evidence of peri-implantitis as evidenced by mesial and distal bone loss more than 1 mm from the accepted reference point round the implants on the periapical radiograph
Demonstrate peri-implant mucositis as evidenced by bleeding on probing with 0.25 N/cm

Exclusion Criteria:

Have allergic reactions to simvastatin
Have peri-implantitis as evidenced by more than 1 mm of mesial and distal bone loss from an accepted reference point on the implants on the periapical radiograph
Demonstrate no bleeding on probing with 0.25 N/ cm
Have uncontrolled systemic disease
Pregnancy or females who suspect/may be pregnant, as well as nursing and breast feeding mothers
Take statin / HMG-CoA reductase inhibitor medications
Smokers
Require antibiotic prophylaxis
Take anti-inflammatory medication, immunosuppressive medications or immunosuppressed patients
Have paraben allergies
Have soybean allergies
Intervention: DUAC gel
Trial phase: Phase 4
SMILES: CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(OP(=O)(O)O)C(O)C2O)N(C)C1.O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face

ONEXTON Topical Gel: Onexton gel applied once daily to face
Eligibility criteria:
Inclusion Criteria:

i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;

A female is considered of childbearing potential unless she is:

postmenopausal for at least 12 months prior to study drug administration
without a uterus and/or both ovaries; or
has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

intrauterine device in use ≥ 90 days prior to study drug administration;
barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
vasectomized partner

[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]

ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement VI) characterized by the following:

IGA Score for acne vulgaris 3
IGA Score for PIH 3

iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control

ii. Allergy/sensitivity to any component of the test treatment

iii. IGA score for acne of 2 (mild) or 4 (severe)

iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)

v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study

vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris

viii. Evidence of recent alcohol or drug abuse

ix. History of poor cooperation, non-compliance with medical treatment, or unreliability

x. Exposure to an investigational study drug within 30 days of the Baseline Visit
Intervention: Methylprednisolone
Trial phase: Phase 4
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: 10 mg/kg, single preoperative infusion

Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery
Eligibility criteria:
Inclusion Criteria:

Age minimum 18
Planned open liver resection (with or without combined ablation and/or
cholecystectomy)
Able to participate (self report pain/nausea)
Understands danish/english, or has an interpreter during admission
Signed consent form

Exclusion Criteria:

ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure
Combined ventral herniotomy with implantation of mesh
Combined with operation on tumor in other organs
Insulin dependent diabetes
Current (<10 days) treatment with systemic glucocorticoids and/or immunosuppressive treatment (not including inhalations)
Epidural anesthesia not feasible
Pregnancy/breastfeeding
Allergy toward study medication
Inoperability
Intervention: Betamethasone
Trial phase: Phase 4
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: 8 mg dexamethasone, single preoperative infusion

Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Eligibility criteria:
Inclusion Criteria:

Age minimum 18
Planned open liver resection (with or without combined ablation and/or
cholecystectomy)
Able to participate (self report pain/nausea)
Understands danish/english, or has an interpreter during admission
Signed consent form

Exclusion Criteria:

ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure
Combined ventral herniotomy with implantation of mesh
Combined with operation on tumor in other organs
Insulin dependent diabetes
Current (<10 days) treatment with systemic glucocorticoids and/or immunosuppressive treatment (not including inhalations)
Epidural anesthesia not feasible
Pregnancy/breastfeeding
Allergy toward study medication
Inoperability