anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dalfampridine
Trial phase: Phase 4
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Adverse events reported by the patients when treated with Fampridine
Eligibility criteria:
Inclusion Criteria:

Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
Subjects must be diagnosed with clinically definite SPMS or PPMS and be judged to be in generally good health by the investigator based upon the results of the medical history, laboratory tests (liver and renal function), physical examination, 12-lead electrocardiogram performed during Screening
Subjects must be Male or female aged 18-70 at baseline
Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive
Evidence of significant upper limb dysfunction as defined by a 9HPT of 15 - 90 seconds (dominant or non-dominant hand)
Female subjects with reproductive capabilities must have a negative serum pregnancy test at baseline and agree to using an acceptable form of contraception for the duration of the study (barrier, coil or oral contraceptives only).

Exclusion Criteria:

Allergy/sensitivity to study medications or their ingredients
Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
Subjects unable to provide written informed consent
Subjects with a history of epilepsy or previous seizures (including provoked seizures).
Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
Subjects with an AST or ALT ≥ 3 x ULN on liver function tests
Subjects have clinically significant ECG findings as judged by the investigator, in particular evidence of a cardiac conduction defect.
Significant upper or lower limb arthritis as considered by the investigator to interfere with study assessments.
Significant cognitive impairment as considered by the investigator to interfere with study assessments
Subjects with clinically significant upper limb ataxia considered by the investigator to interfere with ability to complete study outcome measures.
Patients with mild, moderate or severe renal impairment (creatinine clearance<80ml/min) measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula
Subjects concomitantly using medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example cimetidine
Concurrent treatment with other medicinal products containing fampridine (4- aminopyridine)
Intervention: Telavancin
Trial phase: Phase 3
ATC code: J01XA03
SMILES: CCCCCCCCCCNCCN[C@@]1(C)C[C@H](O[C@H]2[C@H](Oc3c4cc5cc3Oc3ccc(cc3Cl)[C@@H](O)[C@@H](NC(=O)[C@@H](CC(C)C)NC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]5C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c5cc(O)c(CNCP(=O)(O)O)c(O)c5-c5cc3ccc5O)[C@H](O)c3ccc(c(Cl)c3)O4)O[C@H](CO)[C@@H](O)[C@@H]2O)O[C@@H](C)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin
Eligibility criteria:
Inclusion Criteria:

18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization

At least one of the following signs or symptoms of bacteremia:

Temperature ≥ 38.0°C
White blood cell (WBC) count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands)
Tachycardia (heart rate > 90 bpm)
Tachypnea (respiratory rate > 20 breaths/min)
Hypotension (systolic blood pressure < 90 mmHg)
Signs or symptoms of localized catheter-related infection
At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.

Exclusion Criteria:

Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)
Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted
Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Loteprednol Etabonate Gel 0.38% administered two times daily (BID)

Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
Eligibility criteria:
Inclusion Criteria:

Visit 1 (Screening Visit)

Be willing and able to comply with all treatment and follow-up/study procedures.
Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Have known hypersensitivity or contraindication to the study drug(s) or their components.
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.

Cholecalciferol 400 IU
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CD
Age >= 18 and <75
Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

Exclusion Criteria:

Corticosteroid use in the last 4 weeks
CD-related surgery in the last 6 months
CD-related hospitalization in the last 4 weeks
Pregnancy, intended pregnancy during the study period or nursing
Serum calcium >10.2 mg/dL
History of primary sclerosing cholangitis
History of undergoing an ileal pouch-anal anastomosis
Current active perianal disease
History of nephrolithiasis in the past 2 years
Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
modified Harvey-Bradshaw Index of 10 or more
History of decreased renal function (glomerular filtration rate <30ml/min based on MDRD) or polycystic kidney disease
History of sarcoidosis
History of hyperparathyroidism
Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
Osteoporosis
Intervention: Afatinib
Trial phase: Phase 4
ATC code: L01EB03 | L01XE13
SMILES: CN(C)C/C=C/C(=O)Nc1cc2c(Nc3ccc(F)c(Cl)c3)ncnc2cc1O[C@H]1CCOC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: All patients received continuous daily treatment with Afatinib at a starting dose of 40 milligram (mg), treatment interruption and reduction scheme to 30 mg and then to 20 mg were permitted to manage treatment-related adverse events (AEs). Patients were orally administered with the film coated tablet once a day without food.
Eligibility criteria:
Inclusion criteria:

Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
Measureable disease according to RECIST 1.1.
Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
Adequate organ function.

Exclusion criteria:

More than one line of prior therapy for disease.
Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
Known pre-existing interstitial lung disease.
Intervention: BENZYL ALCOHOL
Trial phase: Phase 4
ATC code: P03AX06
SMILES: OCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: for ultrasound guided hip joint injection local anesthesia

bacteriostatic saline
Eligibility criteria:
INCLUSION CRITERIA:

age 18-75 years
referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine & Rehabilitation Clinic, or Musculoskeletal Clinic

EXCLUSION CRITERIA:

chronic opioid use
opioid use on day of procedure
history of fibromyalgia or other diffuse chronic pain syndrome
pain behavior during the clinical encounter as judged by the injectionist
anesthetic administration time outside the designated 5-15 second time frame
Intervention: Ketoprofen
Trial phase: Phase 1
ATC code: M01AE03 | M01AE17 | M01AE53 | M02AA10 | M02AA27 | N02AJ14
SMILES: CC(C(=O)O)c1cccc(C(=O)c2ccccc2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: 25mg DKP.TRIS tablet

Keral® tablet: One dose of 25 mg DKP tablet
Eligibility criteria:
Inclusion Criteria:

- Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI) between 18 Kg/m2 and 28 Kg/m2-

Exclusion Criteria:

History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs (aspirin, ibuprofen etc).
Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs.
Surgery within previous 6 months, or blood loss > 400 mL within previous 3 months.
Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
History of clinically significant alcohol, medicine or drug abuse.
Intervention: Metronidazole
Trial phase: Phase 3
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days

Metronidazole (male partner): 500 mg PO BID for 7 days
Eligibility criteria:
Inclusion Criteria: Female

At least 18 years of age (19 years of age in Alabama due to State law)
Sexual partner to a female who meets study eligibility
Willingness to provide informed consent
Willingness to abstain from sexual intercourse or use condoms {during the study}
Willingness to abstain from alcohol for the first week of the study

Inclusion Criteria: Male

At least 18 years of age (19 years of age in Alabama due to State law)
Heterosexual with a regular partner
History of 2 or more episodes of BV in the previous 12 months
Symptoms of BV including vaginal discharge and/or odor
Positive Amsel criteria for BV including vaginal pH >4.5, positive whiff test, presence of clue cells
Willingness to provide informed consent
Willingness to abstain from sexual intercourse or use condoms {during the study}
Willingness to abstain from alcohol for the first week of the study

Exclusion criteria (both genders)

Allergy to metronidazole
Failure of the male partner to keep his appointment to be seen within 48 hours
Pregnant or breast feeding (females)
HIV or other chronic disease which in the opinion of the investigator would interfere with the ability to participate in this study
Subject requires concurrent lithium, coumadin, dilantin, or antabuse
Presence of trichomonas on wet prep of vaginal fluid (females)
Women with a history of recurrent BV for >3 years or women who have failed previous treatment studies for BV
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Temozolomide dose 150/200 mg/m2/d for 5 days every 28 days for 6 cycles (total 12 cycles of adjuvant temozolomide).
Eligibility criteria:
Inclusion Criteria:

Ability to understand and sign the informed consent document .
Age greater than or equal 18.
Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease.
Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made in the center of origin the result of the center will be accepted ).
Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
Index greater than or equal 60 % Karnofsky.
All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( NMR performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed).
Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell> 3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul.
Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
Serum bilirubin <1.5 / ULN; SGOT , SGPT < 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases .
Effective contraceptive method in patients and their partners.

Exclusion Criteria:

Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth.
Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
Concurrent disease that prevents the continuation of temozolomide treatment.
Presence of leptomeningeal dissemination.
Pregnant or breastfeeding.
Positive patients receiving combination antiretroviral therapy in HIV
Intervention: Aprepitant
Trial phase: Phase 2
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Eligibility criteria:
Inclusion Criteria:

Males or females from 18-70 years of age
Meets DSM IV criteria for current alcohol and cannabis dependence
Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
Negative BAC and a CIWA score < 9 at randomization

Exclusion Criteria:

Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
Prior treatment with NK1 antagonists
Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
Intervention: Bupivacaine
Trial phase: Phase 1
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.

EXPAREL
Eligibility criteria:
Inclusion Criteria:

Males or females ≥18 years of age.
American Society of Anesthesiologists (ASA) physical status 1 or 2.
Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
History of abnormal bleeding tendencies/clotting disorders.
Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
Received bupivacaine or other local anesthetic within 7 days of first study drug administration.
Intervention: Bupivacaine
Trial phase: Phase 1
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.

EXPAREL
Eligibility criteria:
Inclusion Criteria:

Males or females ≥18 years of age.
American Society of Anesthesiologists (ASA) physical status 1 or 2.
Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
History of abnormal bleeding tendencies/clotting disorders.
Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
Received bupivacaine or other local anesthetic within 7 days of first study drug administration.
Intervention: Acalabrutinib
Trial phase: Phase 1
ATC code: L01EL02
SMILES: CC#CC(=O)N1CCC[C@H]1c1nc(-c2ccc(C(=O)Nc3ccccn3)cc2)c2c(N)nccn12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Acalabrutinib 100 mg twice daily (bid) continuously
Eligibility criteria:
Inclusion Criteria:

Men and women ≥ 18 years of age.
A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior therapy for MM, and is progressing at the time of study entry.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Breast feeding or pregnant
Intervention: Dihomo-gamma-linolenic acid
Trial phase: Phase 2
SMILES: CCCCC/C=C\C/C=C\C/C=C\CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Oral DS107 2g, 4 x 500mg capsules administered orally once a day
Eligibility criteria:
Inclusion Criteria:

Male or female subject aged 18 years and older.
Moderate to severe atopic dermatitis.

Exclusion Criteria:

Clinically significant impairment of renal or hepatic function.
History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.