anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Alvelestat
Trial phase: Phase 2
SMILES: Cc1c(-c2ccnn2C)cc(C(=O)NCc2ccc(S(C)(=O)=O)cn2)c(=O)n1-c1cccc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 313
Group description: AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COPD with symptoms over 1 year
FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion Criteria:

Past history or current evidence of clinically significant heart disease
Current diagnosis of asthma
Patients who require long term oxygen therapy
Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants must be 18 years of age or older of all racial and ethnic origins, and capable of giving informed consent. Spanish speaking individuals are eligible for participation.

Additionally they must be/have:

Biologically male (not transgendered)
HIV positive for at least 24 months,
On stable HAART for at least the last 3 months prior to entering the study,
Practitioner diagnosed lipodystrophy as defined by:

aHAL (any of these) decreased subcutaneous fat in the limbs with prominent veins, loss of buttock fat or facial atrophy hHAL: fat accumulation in abdomen and/or dorsocervical region

Exclusion Criteria:

Participants cannot be less than 18 years of age, institutionalized, nor have prior diseases or conditions that may alter body fat composition. Exclusions:

Females are excluded
Prior history of CHF
Prior history of macular retinal edema
Prior history of spontaneous bone fracture
Diabetics receiving oral/injected/inhaled diabetic agents or individuals with a fasting blood glucose value greater than or equal to 140 within the last 90 days.

Current active opportunistic infections for example :

PCP pneumonia
Neuropathy
Thrush
Systemic KS (Kaposi sarcoma)

i) localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis

Planning to discontinue HAART
Current diagnosis of cancer or receiving chemotherapy
Systemic steroid use during the prior 6 months
Hepatitis C+ or previous diagnosis of cirrhosis
Liver Function Studies great than or equal to triple of normal values
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: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older
Scheduled for cataract surgery by phacoemulsification
Subject must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis
Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months
No ocular use of prostaglandins within 2 weeks of surgery
Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery
Contraindications to NSAIDs
Active ocular infection
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 37
Group description: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Eligibility criteria:
Inclusion Criteria:

Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
Children who have minimal to moderate inadequate eyelashes due to alopecia areata
Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion Criteria:

Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
Use of over the counter eyelash growth products within 6 months.
Use of prescription eyelash growth products (eg, Latisse®)
Any eye condition that would prevent required ophthalmology exams
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Male or female subjects 12 years of age or older
Documented history of season allergic rhinitis to mountain cedar pollen
General good health
Other criteria apply

Exclusion Criteria:

History of physical findings of nasal pathology (within 60 days prior to screening visit)
Participation in any investigational drug study 30 days preceding screening visit
History of respiratory infection/disorder with 14 days preceding screening visit
Use of any prohibited concomitant medications
Other criteria apply
Intervention: CID 12303048
Trial phase: Phase 3
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
Eligibility criteria:
Inclusion Criteria:

Be aged 18 to 65 years inclusive
Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
Give written informed consent
Be in good general health
No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

Medical condition which requires pre-medication (antibiotics) prior to dental
Visits/procedures
Allergy to chlorhexidine
Advanced periodontal disease (gum disease)
5 or more decayed, untreated dental sites (cavities)
Diseases of the soft or hard oral tissues (gums or palate)
Orthodontic appliances that interfere with plaque rating
Abnormal salivary function
Use of drugs that can affect currently salivary flow or production
Use of antibiotics one (1) month prior to or during this study
Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
Pregnant or breastfeeding.
Participation in another research study in the month preceding this study
Allergic to common toothpaste or mouth rinse ingredients.
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Intervention: Daptomycin
Trial phase: Not Applicable
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Eligibility criteria:
Inclusion Criteria:

Adults with suspected EVD related meningitis or ventriculitis who already have an external ventricular drain placed, as part of standard clinical care for CSF drainage, and whose clinicians plan to start antibiotics. There should be a clinical indication for the EVD to be in place for ≥ 72 hrs. An intravenous line which can be accessed for blood draws should be present.

Exclusion Criteria:

Age less than 18 years of age Patient is a woman who is pregnant or lactating Allergies or prior adverse reactions to daptomycin, which would preclude its use.

Elevated CK levels (>500). Inability to obtain informed consent or get proxy consent. Patients on CRRT (continuous renal replacement therapies) or on dialysis Patients with an estimated CrCl <30 cc/min as estimated by MDRD at base line. Patients with a BMI >30 Any medical condition leading to a life expectancy of < 48 hours, as determined by the clinician.

Patient who have received a dose of daptomycin in the last 7 days. Patients is participating in other studies
Intervention: Gadobutrol
Trial phase: Phase 4
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Patient received contrast-enhanced MRA with Gadovist
Eligibility criteria:
Inclusion Criteria:

Male or female, aged ≥ 18 years.
Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria:

Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Intervention: Gadoteric acid
Trial phase: Phase 4
ATC code: V08CA02
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(CC(=O)O)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Patients received contrast-enhanced MRA with Dotarem
Eligibility criteria:
Inclusion Criteria:

Male or female, aged ≥ 18 years.
Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria:

Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Intervention: Acyclovir
Trial phase: Phase 4
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: acyclovir 400 mg twice daily 400 mg either in first intervention period or second
Eligibility criteria:
Inclusion Criteria:

HIV-1 seropositive
Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
CD4 cell count >250 cell/µL
Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
Detectable HIV-1 plasma viral load
HSV-2 seropositive
Not intending to move out of the area for the duration of study participation.
Able to participate in the study at the Partners in Prevention site in Thika, Kenya

Exclusion Criteria:

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
Planned use of acyclovir, valacyclovir, or famciclovir
Use of ganciclovir, foscarnet, or cidofovir
Known medical history of seizures
Serum creatinine >1.5 mg/dL
AST or ALT >3 times upper limit of normal
Hematocrit <30 %
Absolute neutrophil count <1000
Platelet count <75,000
History of thrombotic microangiopathy
Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
Participation in another HIV therapeutics trial
For women, pregnancy as confirmed by a urine pregnancy test
Intervention: VALACYCLOVIR
Trial phase: Phase 4
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: valacyclovir 1.5 g twice daily either in first intervention period or second
Eligibility criteria:
Inclusion Criteria:

HIV-1 seropositive
Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
CD4 cell count >250 cell/µL
Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
Detectable HIV-1 plasma viral load
HSV-2 seropositive
Not intending to move out of the area for the duration of study participation.
Able to participate in the study at the Partners in Prevention site in Thika, Kenya

Exclusion Criteria:

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
Planned use of acyclovir, valacyclovir, or famciclovir
Use of ganciclovir, foscarnet, or cidofovir
Known medical history of seizures
Serum creatinine >1.5 mg/dL
AST or ALT >3 times upper limit of normal
Hematocrit <30 %
Absolute neutrophil count <1000
Platelet count <75,000
History of thrombotic microangiopathy
Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
Participation in another HIV therapeutics trial
For women, pregnancy as confirmed by a urine pregnancy test
Intervention: Aristospan
Trial phase: Not Applicable
SMILES: CC(C)(C)CC(=O)OCC(=O)C12OC(C)(C)OC1CC1C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC12C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Eligibility criteria:
Inclusion Criteria:

age of 4 to 12 years
diagnosed with Idiopathic osteonecrosis of the femoral head
symptoms less than 12 months old.

Exclusion Criteria:

Symptoms for more than 12 months
Previous treatment other than anti-inflammatories, crutches or bed rest
Subjects more than 8 years old or have a hand bone age greater than 6 years old and lateral pillar B or B/C disease.
Bilateral hip disease
Personal or family history of problems with general anesthesia
Prior steroid treatment

Previous diagnosis of:

Asthma
Identifiable rheumatologic condition
Metabolic Diseases (including but not limited to Gaucher's disease or congenital hypothyroidism)
Sickle cell disease
Known pain syndrome
Hip sepsis
Prior malignancy (solid organ or bone marrow transplant)
Blood Clotting disorder
Intervention: Betamethasone
Trial phase: Phase 1 | Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Dexamethasone 700 ug intravitreal implant on Day 1.
Eligibility criteria:
Inclusion Criteria:

macular edema due to retinal vein occlusion
visual acuity in the study eye between 20/320 to 20/40

Exclusion Criteria:

cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
use of injectable drugs in the study eye within 2 months prior to day 1
active eye infection in either eye
visual acuity in the non-study eye of 20/200 or worse
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 28
Group description: Montelukast: 1 pill per day for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Eligible for inclusion in the study will be symptomatic snoring children >2 years of age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST (hour total sleep time), and in whom T&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic abnormalities, acute upper respiratory tract infection, systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and children who already had adenotonsillectomy. In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 29
Group description: Placebo: 1 pill per day for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Eligible for inclusion in the study will be symptomatic snoring children >2 years of age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST (hour total sleep time), and in whom T&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic abnormalities, acute upper respiratory tract infection, systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and children who already had adenotonsillectomy. In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.
Intervention: Doripenem
Trial phase: Phase 4
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Eligibility criteria:
Inclusion Criteria:

Patients are 18 years of age or older
Admitted to Emory surgical intensive care unit (ICU) service
Have a diagnosis of sepsis that requires empiric antimicrobial therapy
Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure

Exclusion Criteria:

Surgical ICU length of stay less than 24 hours
Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)
Pregnancy
Known allergy to beta-lactam antibiotics
Non-English-speaking patients
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Subjects must have a clinical diagnosis of BKC in at least one eye
Subjects must be willing to discontinue contact lens use for the duration of the study
Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
Subjects having ocular surgery (including laser surgery) in either eye within the past three months.