anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Indacaterol
Trial phase: Phase 4
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Eligibility criteria:
Inclusion criteria

Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
Patients diagnosed with COPD at 40 years of age or older.
Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
Patients with stable COPD in Patient Group B according to GOLD 2014.

Exclusion criteria

Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
Patients with a history of asthma.
Intervention: Humulin N
Trial phase: Phase 1 | Phase 2
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.

Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.

The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation.
Eligibility criteria:
Inclusion Criteria:

Brazilian,
bedridden,
of both genders,
aged between 45 and 75 years old, and
diabetic or not.

Exclusion Criteria:

hyperglycemic volunteers, and
those with pressure ulcers other than grade II.
Intervention: SALICYLIC ACID
Trial phase: Phase 1 | Phase 2
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.

Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.

The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation.
Eligibility criteria:
Inclusion Criteria:

Brazilian,
bedridden,
of both genders,
aged between 45 and 75 years old, and
diabetic or not.

Exclusion Criteria:

hyperglycemic volunteers, and
those with pressure ulcers other than grade II.
Intervention: Secnidazole
Trial phase: Phase 3
ATC code: J01RA07 | P01AB07
SMILES: Cc1ncc([N+](=O)[O-])n1CC(C)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: 2 grams administered orally as a single dose

SYM-1219
Eligibility criteria:
Inclusion Criteria:

Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Off-white (milky or gray), thin, homogeneous vaginal discharge
Vaginal pH ≥ 4.7
Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
A positive 10% KOH Whiff test
Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)

Exclusion Criteria:

Are pregnant, lactating, or planning to become pregnant during the study
Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)
Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)
Intervention: IC Green
Trial phase: Not Applicable
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Eligibility criteria:
Inclusion Criteria:

Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer
Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy
Participants with planned axillary sentinel node biopsy procedure

Exclusion Criteria:

Participants with cancer > 3 cm
Participants with clinically positive nodes
Participants with prior surgery for breast cancer in the index breast
Participants who have had bilateral breast surgeries
Thyroid dysfunction
Hypersensitivity to iodine
Hepatic insufficiency
Renal insufficiency
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal

Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Undergoing unilateral knee replacement
If female, not pregnant
Agree to participate in the follow-up appointment
Understand and sign the informed consent form

Exclusion Criteria:

• Bilateral TKA planned

Use of narcotic medication before surgery
Any other surgery within the three months prior to TKR
Inflammatory arthritis
Any chronic pain conditions or problems, including but not limited to chronic back pain, fibromyalgia or multiple sclerosis
Osteoarthritis of the non-operative knee
Osteoarthritis of one or both hips
Intervention: Ceftolozane
Trial phase: Phase 4
SMILES: Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)/C(=N\OC(C)(C)C(=O)[O-])c3nsc(N)n3)[C@H]2SC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses

Ceftolozane/Tazobactam: 1 hour intravenous infusion
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Documented diagnosis of CF
Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment
If female, subjects must be non-pregnant and non-lactating. Females can be either not of a child-bearing potential or if of a child-bearing potential, on acceptable modes of birth control such as abstinence from sexual intercourse, oral/parenteral contraceptives, or barrier method

Exclusion Criteria:

History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
Prior (within 24 hours of first dose of study drug) or concomitant receipt of piperacillin/tazobactam or probenecid
History of lung transplant
Moderate to severe renal dysfunction defined as a creatinine clearance < 50 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
A hemoglobin less than 8 gm/dl at baseline
Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
Planned or prior participation in any other interventional drug study within 30 days
Intervention: Betamethasone Sodium Phosphate
Trial phase: Phase 4
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)COP(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 1 cc dexamethasone sodium phosphate (4mg/ml) injectable

Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Eligibility criteria:
Inclusion Criteria:

Age 18-90
Male or female (non-pregnant)
Clinically diagnosed trigger digit
Subject is able to provide voluntary, written informed consent
Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Exclusion Criteria:

Age <18 or >90
Pregnant or lactating women
Non-English speaking individuals
Medication contradictions to lidocaine, corticosteroids and/or saline
Prior injection or surgery on the affected finger
Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
Open wound
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 261
Group description: Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Eligibility criteria:
Inclusion Criteria:

Participant who gave written informed consent to participate in the study in accordance with local regulations.
Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
At the Screening Visit, A1C was between 7.0% to 11.0%.
Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
Chronic systemic corticosteroid use.
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 263
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Eligibility criteria:
Inclusion Criteria:

Participant who gave written informed consent to participate in the study in accordance with local regulations.
Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
At the Screening Visit, A1C was between 7.0% to 11.0%.
Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
Chronic systemic corticosteroid use.
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.

ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Eligibility criteria:
Inclusion Criteria:

History of or current depression scoring five or above on Goldberg Depression Screen

Exclusion Criteria:

Uncontrolled hypertension, allergy to ketamine,pregnancy
Intervention: Icosapent
Trial phase: Phase 3
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day

Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
Eligibility criteria:
Inclusion Criteria:

Age 30+ years
Hypertriglyceridemia (150-400 mg/dl)
Statin use for at least six months at the time of screening
Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year
Ability to provide informed consent and provide blood samples
Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks)
Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits
Reactive hyperemia index (RHI) of ≤ 2.0

Exclusion Criteria:

Eating disorder or heavy drinkers
Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification
Pregnant or lactating women
Statin use <6 months at the time of screening
Allergy to EPA, fish oil, or other omega-3 fatty acids
Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids.
Inability to provide informed consent or blood samples
History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
Diagnosis of diabetes < 1 year prior to enrollment
Intention to move out of greater Boston area within one year
Current use of omega-3 supplements, fish oil, or >2 servings of fish per week
Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders
Treatment with blood thinning drugs (i.e. warfarin and clopidogrel)
Major surgical operation 3 months before or after screening
Organ transplantation
Current participation in another trial or plan to do so during the study
Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital
RHI of >2.0
Triglycerides <150 mg/dl or >400 mg/dl
Body mass index of 40+ kg/m2
Intervention: Dalfampridine
Trial phase: Phase 3
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

dalfampridine-ER 7.5 mg
Eligibility criteria:
Key Inclusion Criteria:

Completion of the DALF-PS-1016 study
Providing informed consent to continue into the DALF-PS-1029 long-term extension study
Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

Key Exclusion Criteria:

Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
Intervention: Dalfampridine
Trial phase: Phase 3
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

dalfampridine-ER 10 mg
Eligibility criteria:
Key Inclusion Criteria:

Completion of the DALF-PS-1016 study
Providing informed consent to continue into the DALF-PS-1029 long-term extension study
Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

Key Exclusion Criteria:

Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
Intervention: Phenazopyridine
Trial phase: Not Applicable
ATC code: G04BX06
SMILES: Nc1ccc(/N=N/c2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Preoperative phenazopyridine
Eligibility criteria:
Inclusion Criteria:

Females only
Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
Age > or = 18 years, no upper age limit
Able and willing to consent

Exclusion Criteria:

Planned surgical procedure where cystoscopy will not be used
Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
age <18 years
pregnancy
unable/unwilling to participate
history of allergy or adverse reaction to phenazopyridine
hepatic dysfunction
known phenazopyridine hypersensitivity
history of urologic surgery
presence of ureteral stents prior to the planned surgical procedure
concomitant suprapubic catheter placement
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: 30 mg ZPL-3893787 orally once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

Eczema Area and Severity Index (EASI) of ≥12 and <48.

An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)

Atopic dermatitis affecting ≥10% BSA

Exclusion Criteria:

AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study

Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.

Have an active skin infection or any other clinically apparent infections.

Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.

Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.

Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.

Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.