anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10898
Group description: a single dose of Azithromycin will be administered to infants between their 8-27th days of life

Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Eligibility criteria:
Communities

Inclusion Criteria:

Within 4 hours of a facility that can provide services for pyloromyotomy (Ouagadougou or Bobo Dioulasso)
Accessible during the rainy season
Ultrasound machine available OR a facility in which an ultrasound machine could be placed is within 1 hour

Exclusion Criteria:

Refusal of village chief

Individuals:

Inclusion Criteria:

Weight over 2500 g
Able to feed orally
Family intends to stay in study area for at least 6 months
Appropriate consent from at least one caregiver
No known allergy to azalides
Not living within one of the communities included in the community study(CHAT/CHATON)
No hepatic failure manifested by neonatal jaundice

Exclusion Criteria:

Weight <2500 g
Unable to feed orally
Family planning to move
Mother/caregiver not willing to participate
Allergic to azalides
Living in one of the communities included in the community study (CHAT/CHATON)
Hepatic failure manifested by neonatal jaundice
Intervention: PROPYLENE GLYCOL
Trial phase: Phase 4
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.

Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
Eligibility criteria:
Inclusion Criteria:

Self-reported contact lens discomfort
Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
Daily disposable contact lens wearer
Best-corrected visual acuity of 20/30 or better

Exclusion Criteria:

All other contact lens types (e.g., currently wearing two week or monthly replacement contact lenses or hard contact lenses)
Non-compliant daily disposable contact lens wearers (must regularly replace contact lenses daily)
Systemic health conditions known to alter tear film physiology
History of ocular surgery within the past 12 months
History of severe ocular trauma, active ocular infection, or inflammation
Currently using Accutane or eye medications
Pregnant or breast feeding
Intervention: Vancomycin
Trial phase: Phase 1
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.

Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
Eligibility criteria:
Inclusion Criteria:

Adult male or females between 18 - 85 years old
Stabilized on a PD regimen for > 3 months prior to study initiation

Exclusion Criteria:

Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator
Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution
Active peritonitis infection
Previous intraperitoneal antibiotic treatment within 2 months
Previous intravenous vancomycin treatment within 2 months
Hemoglobin < 9 g/dL
Pregnant or breast-feeding women
Intervention: Clotrimazole
Trial phase: Phase 3
ATC code: A01AB18 | D01AC01 | G01AF02 | G01AF20
SMILES: Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Investigational treatment

1 vial twice daily
Eligibility criteria:
Main Inclusion Criteria:

At least 18 years of age
Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
Signs/symptoms of pruritus, otalgia and ear fullness.
Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

Known bacterial otitis externa or malignant otitis externa.
Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
Structural ear anomalies which may difficult the evaluation of the therapeutic response.
Uncontrolled diabetes mellitus.
Any infection requiring systemic antimicrobial or systemic antifungal therapy.
Concomitant medicines that may interfere with the study evaluations.
Intervention: Clotrimazole
Trial phase: Phase 3
ATC code: A01AB18 | D01AC01 | G01AF02 | G01AF20
SMILES: Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Investigational treatment
Eligibility criteria:
Main Inclusion Criteria:

At least 18 years of age
Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
Signs/symptoms of pruritus, otalgia and ear fullness.
Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

Known bacterial otitis externa or malignant otitis externa.
Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
Structural ear anomalies which may difficult the evaluation of the therapeutic response.
Uncontrolled diabetes mellitus.
Any infection requiring systemic antimicrobial or systemic antifungal therapy.
Concomitant medicines that may interfere with the study evaluations.
Intervention: SULFUR HEXAFLUORIDE
Trial phase: Phase 2
ATC code: V08DA05
SMILES: FS(F)(F)(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 37
Group description: IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, up to 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.

Sulfur hexafluoride lipid-type A microspheres: Contrast Enhanced Ultrasound of the appendix
Eligibility criteria:
Inclusion Criteria:

Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
Age 8 through 17 years
seen between Institutional Review Board (IRB) approval date and 12/31/2019
Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
Has had an IV catheter placed as part of their standard of care

Exclusion Criteria:

Known cardiac abnormality
Pulmonary hypertension
Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
Does not had an IV catheter placed
Unable to roll over
Unable to assent
Pregnant
Lactating
Received an ultrasound image from a referring facility
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: 11
Group description: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
Eligibility criteria:
Inclusion Criteria:

Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
Treating physician has already indicated a need for a prostate biopsy procedure.
Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

Prostate biopsy within 12 weeks before enrollment
Acute prostatitis within the last 6 months
Current non-urologic bacterial infection requiring active treatment with antibiotics
Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
Body weight greater than 350 lbs (158 Kg)
Inability or unwillingness to receive a prostate biopsy procedure
Unable to lie flat, still, or tolerate a PET/CT scan
Unable to provide own consent
Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
Intervention: Avasopasem manganese
Trial phase: Phase 3
SMILES: [Cl-].[Cl-].[Mn+2].c1cc2nc(c1)CNC1CCCCC1NCCNC1CCCCC1NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 241
Group description: GC4419 90mg: 60 minute IV infusion
Eligibility criteria:
Inclusion Criteria:

squamous cell carcinoma of the head and neck
treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
Treatment plan to receive standard cisplatin monotherapy
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate hematologic, renal and liver function
Negative serum pregnancy test
Use of effective contraception

Exclusion Criteria:

Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
Metastatic disease
Prior radiotherapy to the region of the study cancer or adjacent anatomical
Prior induction chemotherapy
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
Concurrent participation in another interventional clinical study
Inability to eat soft solid food at baseline
Malignant tumors other than HNC within the last 5 years
Active infectious disease excluding oral candidiasis
Presence of oral mucositis at baseline
Known history of HIV or active hepatitis B/C
Female patients who are pregnant or breastfeeding
Known allergies or intolerance to cisplatin and similar platinum-containing compounds
Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
Eligibility criteria:
Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment
Completion of the treatment period as specified in the parent study
Acceptable demonstration of tolerance to study drug during the parent study as determined by the investigator or Medical Monitor
For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12 weeks of the study
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 weeks after the final dose of fenebrutinib
Treatment with any investigational agent or live/attenuated vaccine in the preceding 6 weeks
Any signs or symptoms of infection judged by the investigator to be clinically significant since completing the treatment period of the parent study
Any significant changes (e.g., events, changes in medication) occurring after completion of participation in the parent study that, in the investigator's judgment, would increase the risk of adverse events in this OLE study
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
Eligibility criteria:
Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment
Completion of the treatment period as specified in the parent study
Acceptable demonstration of tolerance to study drug during the parent study as determined by the investigator or Medical Monitor
For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12 weeks of the study
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 weeks after the final dose of fenebrutinib
Treatment with any investigational agent or live/attenuated vaccine in the preceding 6 weeks
Any signs or symptoms of infection judged by the investigator to be clinically significant since completing the treatment period of the parent study
Any significant changes (e.g., events, changes in medication) occurring after completion of participation in the parent study that, in the investigator's judgment, would increase the risk of adverse events in this OLE study
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Eligibility criteria:
Inclusion Criteria:

Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.

Exclusion Criteria:

Prior injections into the same knee within the past 6 months,
Pregnant and/or lactating women,
Inflammatory joint disease including rheumatoid or psoriatic arthritis,
Concurrent use of anti-rheumatic drugs,
Allergy or hypersensitivity to the study medications,
Patients on an active pain management contract,
Patients with insurance that requires pre-certification for any of the study drugs,
Inability to make own decisions regarding the informed consent,
Inability to read and/or understand English,
Patients who are unable to return for follow-up or be reached by phone.
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Eligibility criteria:
Inclusion Criteria:

Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.

Exclusion Criteria:

Prior injections into the same knee within the past 6 months,
Pregnant and/or lactating women,
Inflammatory joint disease including rheumatoid or psoriatic arthritis,
Concurrent use of anti-rheumatic drugs,
Allergy or hypersensitivity to the study medications,
Patients on an active pain management contract,
Patients with insurance that requires pre-certification for any of the study drugs,
Inability to make own decisions regarding the informed consent,
Inability to read and/or understand English,
Patients who are unable to return for follow-up or be reached by phone.
Intervention: Pazufloxacin
Trial phase: Phase 3
ATC code: J01MA18
SMILES: [H][C@]1(C)COc2c(C3(N)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.

Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic

1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent.
Age ≥ 1 year.
Both genders.
Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia

Exclusion Criteria:

Pregnant women, lactating or planning to become pregnant.
Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
Participation in another clinical research study ≤ 30 days before the baseline visit.
Previous participation in this same study.
That they can not comply with their attendance at appointments or with all the requirements of the protocol.
Single eye
Presence of corneal abrasion or corneal ulceration in the study eye.
History Users of contact lenses who are not willing to suspend their use during the study.
Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.
Antecedents of eye surgery 6 weeks prior to study entry.
Viral or allergic conjunctivitis.
Active uveitis.
Active ulcerative keratitis.
Recurrent corneal erosion syndrome
Antecedent of hypersensitivity or allergy to fluoroquinolones.
Intervention: Gatifloxacin
Trial phase: Phase 3
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.

Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic

1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent.
Age ≥ 1 year.
Both genders.
Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia

Exclusion Criteria:

Pregnant women, lactating or planning to become pregnant.
Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
Participation in another clinical research study ≤ 30 days before the baseline visit.
Previous participation in this same study.
That they can not comply with their attendance at appointments or with all the requirements of the protocol.
Single eye
Presence of corneal abrasion or corneal ulceration in the study eye.
History Users of contact lenses who are not willing to suspend their use during the study.
Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.
Antecedents of eye surgery 6 weeks prior to study entry.
Viral or allergic conjunctivitis.
Active uveitis.
Active ulcerative keratitis.
Recurrent corneal erosion syndrome
Antecedent of hypersensitivity or allergy to fluoroquinolones.
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: We will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Eligibility criteria:
Inclusion Criteria:

Reproductive-age women (age 18-45) with dysmenorrhea
Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers
Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)

Exclusion Criteria:

Presence of active pelvic or abdominal malignancies (primary or metastatic)
Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
Active genitourinary infection in the last four weeks
Unable to read or comprehend the informed consent in English
Unwilling to complete study procedures
Presence of hypertension or risk for developing hypertension
Unwillingness to take naproxen and/or placebo
Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)
Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
Intervention: OMIDENEPAG ISOPROPYL
Trial phase: Phase 3
ATC code: G01AE10
SMILES: CC(C)OC(=O)CNc1cccc(CN(Cc2ccc(-n3cccn3)cc2)S(=O)(=O)c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Eligibility criteria:
Inclusion Criteria:

Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
Provide signed written informed consent.
Diagnosis of POAG or OHT in both eyes.
Qualifying corrected visual acuity in each eye.
Qualifying central corneal thickness in each eye.
Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
Qualifying Anterior chamber angle.
Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Exclusion Criteria:

Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
Patients with prior exposure to DE-117.
History of ocular surgery specifically intended to lower IOP
Advanced glaucoma in either eye.
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
Females who are pregnant, nursing, or planning a pregnancy.