anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Flunisolide
Trial phase: Not Applicable
ATC code: R01AD04 | R03BA03
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period

Flunisolide HFA
Eligibility criteria:
Inclusion Criteria:

Diagnosis of asthma
Informed consent by parent or legal guardian
6 years to 18 years of age at screening visit
ability to comply with medication use, study visits and study procedures as judged by the site investigator
FEF 25-75% <65% of predicted as a marker for small airway disease

Exclusion Criteria:

Acute wheezing at screening visit or at Baseline visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
Oxygen saturation <95% at screening visit or at Baseline visit
Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
Potential subjects who are pregnant may not enroll in the study
Intervention: Dexmedetomidine
Trial phase: Phase 1 | Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10mins by nurse staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg.

Dexmedetomidine: Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10 minutes by nursing staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg. This dosage is within the FDA-approved package insert parameters. Heart rate, blood pressure and oxygen saturation will be closely monitored by a staff RN already trained to provide care in the procedure room. 1 hour prior to- and after completion of the burn dressing change each day using a 100-mm visual analog scale. Patients will both rate their satisfaction with PCA-DEX for anxiety management after each completion of the burn dressing change.
Eligibility criteria:
Inclusion Criteria:

Patients age 18- 89 admitted for initial management of a thermal burn injury (flame, scald, contact) with >1% total body surface area
Expected stay on the Burn Center for 3 or more days
Read, write and speak English
Burn injury experienced <48 hours prior to admission to the Burn Center for care

Exclusion Criteria:

Patients who are pregnant
Patients that are incarcerated
Patients in active alcohol withdrawal
Patients with current hemodynamic instability (current hypotension systolic blood pressure <100 mmHg, sustained heart rate < 60 beats/min without a pacemaker, symptomatic bradycardia, or second or third degree heart block)
Cannot use push button PCA device (i.e., paralysis)
Acute hepatitis
Acute liver failure
Acute stroke
Acute seizures
Acute myocardial infarction
Severe cognition or communication difficulties (e.g., coma, deafness without signing literacy, dementia, non-English speaking)
Chemical or electrical burn injury
Any condition precluding inclusion at the discretion of the burn surgeons
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 2
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 22
Group description: BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
Must have a body weight of ≥30 kg at Screening and Day 1.
Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman 2011] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for pediatric MS (2013) [Krupp 2013].

Key Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS (as defined by [Lublin and Reingold 1996]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Sildenafil
Trial phase: Not Applicable
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: 20 mg twice a day orally

Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis.
Eligibility criteria:
Inclusion Criteria:

Age ≥19 years of age male or female
Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery

Exclusion Criteria:

Patient currently on nitrate therapy or any nitric oxide donor in any form
Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg.
Patient life expectancy < nine months.
Patient unable or unwilling to meet study requirements.
Intervention: Vamorolone
Trial phase: Phase 1
ATC code: H02AB18
SMILES: CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
Eligibility criteria:
Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters
Intervention: Vamorolone
Trial phase: Phase 1
ATC code: H02AB18
SMILES: CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Eligibility criteria:
Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters
Intervention: Vamorolone
Trial phase: Phase 1
ATC code: H02AB18
SMILES: CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
Eligibility criteria:
Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters
Intervention: Vamorolone
Trial phase: Phase 1
ATC code: H02AB18
SMILES: CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
Eligibility criteria:
Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters
Intervention: Vamorolone
Trial phase: Phase 1
ATC code: H02AB18
SMILES: CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
Eligibility criteria:
Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters
Intervention: Perampanel
Trial phase: Phase 3
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
Eligibility criteria:
Inclusion Criteria

Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel).
Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained.
Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).

Exclusion Criteria

Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study.
Female participants who are nursing, pregnant, or planning to become pregnant.
Intervention: Povidone iodine
Trial phase: Not Applicable
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: One time in-office use (4-5 drops)

Betadine 5%: One-time, in-office administration of Betadine 5%.

Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions.
Eligibility criteria:
Inclusion Criteria:

Age: Patients will be 18 years and older.
Duration of pink eye symptoms: No more than 4 days in first affected eye Positive immunoassay test "AdenoPlus(TM)" for presence of adenovirus.
Sex: "Pink eye" {adenoviral conjunctivitis (Ad-Cs)} occurs with equal prevalence in males and females, therefore we will recruit both genders.
Race/Ethnicity: Individuals of all races and ethnicities will be invited to participate in this study. Patient recruitment will reflect the distribution of race/ethnicity demographics for the patient population specific to each study site.

Exclusion Criteria:

Patients with history of herpes simplex infection or corneal ulceration
Eye surgery in the last 3 months
Intervention: Silibinin
Trial phase: Phase 2
ATC code: A05BA03
SMILES: COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Each subject will have a 6 week treatment phase with milk thistle.

Milk Thistle
Eligibility criteria:
Inclusion Criteria:

Males and females ages 10-65.
Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
Hair-pulling behavior within 2 weeks prior to enrollment;
Child able and willing to provide active assent for participation;
Legal guardian available to provide consent for participation.

Exclusion Criteria:

Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;
Unstable medical illness as determined by the investigator;
History of seizures;
Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;
Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
Previous treatment with milk thistle;
Any history of psychiatric hospitalization in the past year.
Intervention: Fluorescein
Trial phase: Not Applicable
ATC code: S01JA01 | S01JA51
SMILES: O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.

Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Eligibility criteria:
Inclusion Criteria:

adult
undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

Chronic kidney disease
known prior surgical removal of kidney or ureteral obstruction
Current ureteral stent placed
Allergy to any of the interventions
Intervention: Decitabine
Trial phase: Phase 3
ATC code: L01BC08
SMILES: Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3) alone.
Eligibility criteria:
Inclusion Criteria:

Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;
Neutrophil and hemoglobin were well recovered;
Full donor chimerism was achieved;
No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Exclusion Criteria:

Patients with malignancy relapse;
Active infections;
Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;
Severe organ damage;
Thrombosis requiring treatment;
Received decitabine following the current transplantation.
Intervention: Diclofenac sodium
Trial phase: Phase 1
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Diclofenac sodium 50 mg oral tablets, single dose
Eligibility criteria:
Inclusion Criteria:

Signed written informed consent before inclusion in the study
Males and females, 25-55 years old
Body Mass Index (BMI): 18.5-30 kg/m2
Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
Ability to comprehend the full nature and purpose of the study
Females of child-bearing potential must use at least one of the following :

A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit A male sexual partner who agreed to use a male condom with spermicide A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year were admitted.

Exclusion Criteria:

Contraindications to MAO-B inhibitors, antiepileptic drugs, or to any NSAIDs
Clinically significant abnormalities in ECG
Clinically significant abnormal physical findings
Clinically significant abnormal laboratory values
Hypersensitivity or history of anaphylaxis to drugs or allergic reactions in general
Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases
Medications, including over the counter medications and herbal remedies, NSAID or anticoagulant use for 2 weeks before and during the entire study; morphine or other similar opioids, SSRIs, SNRIs, tri- or tetracyclic antidepressant, tramadol, pethidine, dextromethorphan, MAO inhibitors, meperidine derivatives and antiepileptic drugs, medicinal products that are BCRP substrates, any known enzyme inhibiting or inducing agent within 4 weeks preceding the screening visit.
Participation in the evaluation of any investigational product for 3 months before the study.
Blood donations for 3 months before the study
History of drug, alcohol, caffeine or tobacco abuse
Positive drug test at screening or day -1
Positive alcohol breath test at day -1
Abnormal diets or substantial changes in eating habits in the 4 weeks before the study; vegetarians
Positive or missing pregnancy test at screening or day -1, pregnant or lactating women
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: All subjects exposed to sham injection
Eligibility criteria:
Inclusion Criteria:

Sign written informed consent form;
Geographic atrophy in both eyes;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Pregnant or lactating women and women of child-bearing potential;
Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
Any contraindications to IVT injections;
Ocular surgery in either eye within 90 days of screening;
Uncontrolled ocular hypertension or glaucoma in the study eye;
Other protocol-specified exclusion criteria may apply.
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 218
Group description: Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

History of or positive test result at Screening for:
human immunodeficiency virus
hepatitis C virus antibody
hepatitis B infection
Drug or alcohol abuse within 1 year prior to Screening.
Prior treatment with any of the following:
cladribine
mitoxantrone
total lymphoid irradiation
alemtuzumab
T-cell or T-cell receptor vaccination
any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
cyclosporine
azathioprine
methotrexate
mycophenolate mofetil
intravenous (IV) Ig
plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Povidone iodine
Trial phase: Phase 4
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 173
Group description: 0.35% povidone-iodine ("Betadine")

Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
Eligibility criteria:
Inclusion Criteria:

Age 3 to 18 years on day of surgery
diagnosis of spinal deformity
undergoing elective posterior spine multi-level instrumentation surgery

Exclusion Criteria:

Documented renal failure
documented allergy to iodine or shellfish
previous spine fusion surgery
undergoing elective posterior spine single-level instrumentation surgery
undergoing anterior spine multi-level instrumentation surgery
current antibiotic use.
Intervention: Misoprostol
Trial phase: Not Applicable
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol).

Misoprostol: To be placed vaginally
Eligibility criteria:
Inclusion Criteria:

45-80yrs of age
Postmenopausal (amenorrhea for greater than 1 year)
May or may not be using hormone replacement therapy
Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures

Exclusion Criteria:

Pregnant
Known Cancer
Known hypersensitivity to prostaglandins.
Those who are breastfeeding