anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: memantine : memantine 5mg - 20mg PO daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients between 18 and 85 years of age at screening.
Patients must provide written informed consent prior to study entry.
Patients must meet DSM-IV-TR (Diagnostic and Statistical Manual IV Text Revision) criteria for Major Depressive Episode of a severity mild, moderate or severe or in partial remission, as confirmed by the MINI.
Patients must have a HAM-D (17-item) score of 16 or higher.

Patients must have been on 1 of the following medications for 4 or more weeks at or above the listed dose with no psychiatric medication dose changes for the past 25 days:

20 mg qD of fluoxetine (Once Daily)
50 mg qD of sertraline
20 mg qD of paroxetine
200 mg qD of fluvoxamine
20 mg qD of citalopram
10 mg qD of escitalopram
150 mg qD of venlafaxine or venlafaxine sustained release
300 mg qD of bupropion or bupropion sustained or extended release
15 mg qD of mirtazapine
60 mg qD of duloxetine
Participants must agree to keep the dose of their existing antidepressant(s) constant throughout the 8-week trial.

Exclusion Criteria:

Diagnosis of bipolar disorder or schizophrenic or schizoaffective disorder.
History of alcohol or drug abuse or dependence within 6 months of enrollment.
Patients who have received ECT (Electroconvulsive Therapy) in the past 3 months.
History of seizures.
Moderate dementia (MMSE score of 20 or less).
Active suicidal ideation: endorsing a 3 (most severe score) on QIDS-SR (Quick Inventory of Depression Symptomatology Self Reports) suicide item OR a score of 2 or higher for the past week on Suicide Scale items 4 or 5 (current suicidal ideation moderate or strong or would avoid taking steps to save life).
Currently taking a mood stabilizer or antipsychotic (except lithium clearly used as an augmenting agent).
Patients who, in the opinion of the investigator, might not be suitable for the study.
Intervention: Gefitinib
Trial phase: Phase 2
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Gefitinib 250mg tablet
Eligibility criteria:
Inclusion Criteria:

Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
WHO Performance Status 0-2
No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

Any evidence of clinically active interstitial lung disease
Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
Patients with previously diagnosed and treated CNS metastases or spinal cord compression
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Participants will take aripiprazole for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)
Treatment with clozapine for at least 1 year
Stable dose of clozapine for at least 1 month
Well established compliance with outpatient medications
Female participants of non-childbearing potential or of childbearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study

Exclusion Criteria:

Current substance abuse
Psychiatrically unstable
Significant medical illness, including severe cardiovascular, hepatic, or renal disease
History of immunosuppression
Current or recent radiation or chemotherapy treatment for cancer
Chronic use of steroids
Pregnant or breastfeeding
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.

Pred Forte: Four drops daily decreasing to once daily over four weeks.
Eligibility criteria:
Inclusion Criteria:

Be willing and able to provide written informed consent.
Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study.
Be male or female of any race at least 18 years of age.
Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.

Exclusion Criteria:

Contraindication to use of corticosteroids.
Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
Laser or any other intraocular surgery within the past three months.
Require use of ocular NSAID or systemic steroids.
Have known allergy or sensitivity to the study medications or their components
Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.

EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks.
Eligibility criteria:
Inclusion Criteria:

Be willing and able to provide written informed consent.
Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study.
Be male or female of any race at least 18 years of age.
Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.

Exclusion Criteria:

Contraindication to use of corticosteroids.
Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
Laser or any other intraocular surgery within the past three months.
Require use of ocular NSAID or systemic steroids.
Have known allergy or sensitivity to the study medications or their components
Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks.
Eligibility criteria:
Inclusion Criteria:

Be willing and able to provide written informed consent.
Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study.
Be male or female of any race at least 18 years of age.
Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.

Exclusion Criteria:

Contraindication to use of corticosteroids.
Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
Laser or any other intraocular surgery within the past three months.
Require use of ocular NSAID or systemic steroids.
Have known allergy or sensitivity to the study medications or their components
Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study
Intervention: OXYBATE
Trial phase: Phase 1
SMILES: O=C(O)CCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria:

Narcoleptic patients with cataplexy

Exclusion Criteria:

Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8030
Group description: Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
Subjects require treatment with aspirin > 325 mg /day
Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7992
Group description: Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
Subjects require treatment with aspirin > 325 mg /day
Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7933
Group description: Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Eligibility criteria:
Inclusion Criteria:

Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
Subjects require treatment with aspirin > 325 mg /day
Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Intervention: Iobitridol
Trial phase: Phase 4
ATC code: V08AB11
SMILES: CN(CC(O)CO)C(=O)c1c(I)c(NC(=O)C(CO)CO)c(I)c(C(=O)N(C)CC(O)CO)c1I
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Patient will be injected with Xenetix 300
Eligibility criteria:
Inclusion Criteria:

Child aged 1 year or above and 16 years or under
Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2)
Patient requiring MSCT with contrast medium injection for diagnosis
Patient who has a blood sample planned in the 24 hours preceding the MSCT scan
Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.
Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.
Patient with national health insurance

Exclusion Criteria:

Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
Patient with known allergy to iodinated contrast agent.
Patient treated with nephrotoxic drugs within one week before first blood sample
Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)
Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.
Breast feeding patient.
Pregnant patient.
Patient already included in this trial
Patient included in another clinical trial involving an investigational drug.
Patients whose degree of cooperation is incompatible with carrying out the study
Intervention: Besifloxacin
Trial phase: Phase 3
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 442
Group description: Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
Eligibility criteria:
Inclusion Criteria:

Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

Pregnant or nursing females.
Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
Use of any antibiotic within 72 hours of treatment.
Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
Intervention: Moxifloxacin
Trial phase: Phase 3
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 579
Group description: Moxifloxacin hydrochloride ophthalmic solution 0.5%
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

Pregnant or nursing females.
Use of any antibiotic within 72 hours of enrollment.
Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
Intervention: Besifloxacin
Trial phase: Phase 3
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 582
Group description: Besifloxacin ophthalmic suspension 0.6%
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

Pregnant or nursing females.
Use of any antibiotic within 72 hours of enrollment.
Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
Intervention: MESALAMINE
Trial phase: Not Applicable
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Asacol total dose in mg/kg given once a day

Asacol: Asacol is given once a day versus twice or three times a day
Eligibility criteria:
Inclusion Criteria:

Ages 6 to 18 years,
Must be able to swallow tablets, and
Biopsy proven ulcerative colitis

Exclusion Criteria:

Allergy or hypersensitivity to Mesalamine or other salicylates
Use of rectal medications
Intervention: MESALAMINE
Trial phase: Not Applicable
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Asacol total dose split BID or TID

Asacol: Asacol is given once a day versus twice or three times a day
Eligibility criteria:
Inclusion Criteria:

Ages 6 to 18 years,
Must be able to swallow tablets, and
Biopsy proven ulcerative colitis

Exclusion Criteria:

Allergy or hypersensitivity to Mesalamine or other salicylates
Use of rectal medications
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: clonidine given in first injection adenosine given in second injection
Eligibility criteria:
Inclusion Criteria:

Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity

Exclusion Criteria:

Pregnancy
Allergy to clonidine
Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)
Intervention: Adenosine
Trial phase: Phase 2
ATC code: C01EB10 | J05AB03 | S01AD06
SMILES: Nc1ncnc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: adenosine given in first injection clonidine given in second injection
Eligibility criteria:
Inclusion Criteria:

Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity

Exclusion Criteria:

Pregnancy
Allergy to clonidine
Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)
Intervention: Dipyridamole
Trial phase: Not Applicable
ATC code: B01AC07
SMILES: OCCN(CCO)c1nc(N2CCCCC2)c2nc(N(CCO)CCO)nc(N3CCCCC3)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Dipyridamole

Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
Eligibility criteria:
Inclusion Criteria:

Subjects between ages 18-65, both males and nonpregnant females (on birth control) Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder Ability to give written informed consent Total BPRS score > 27 Psychosis subscale scores > 7

Exclusion Criteria:

Patients with coagulative disorders, bleeding diathesis or currently on anticoagulants, and patients with major medical illnesses (including hypertension, angina, and cardiovascular diseases) or an abnormal baseline ECG.

Patients with moderate to severe mental retardation.

Inability to sign informed consent.

Patients with a history of serious violence (e.g., suicide attempts, or assaultive behavior).

Patients on clozapine treatment within the 6 weeks leading to the double-blind phase.

Patients with a history of olanzapine non-response

Positive Urine Toxicology Screen