anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Minocycline
Trial phase: Not Applicable
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Minocycline: Minocycline Dosing:

Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition.
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Male or Female
Age: 18 to 65 years
Caucasian or Non-Caucasian
At least six months of clozapine treatment
Clozapine treatment for incomplete symptoms response (evidence of two failed previous trials of antipsychotics)
Current dose of 200 mg/day for at least 3 months AND a documented clozapine blood level 350 ng/ml prior to study start (maximum clozapine dose of 900 mg/day)
BPRS total score of 45 or more on the 18 item version (scale: 1-7)
BPRS positive symptom item total score of 8 or more
BPRS positive symptom score of 4 or greater on at least one item

Exclusion Criteria:

History of organic brain disease
DSM-IV diagnosis of Mental Retardation
DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)
Pregnancy or lactation
Significant renal or liver impairment
Previous known hypersensitivity to tetracyclines
Current treatment with tetracycline or derivative
Current treatment with lamotrigine
Treatment with oral contraceptives
Current known infection
Treatment with cholestyramine or colestipol
Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
Treatment with warfarin
Abnormal (considered positive) Lyme titer
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Drug
Eligibility criteria:
Inclusion Criteria:

Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign & symptom score and positive microscopy

Exclusion Criteria:

Allergy to the allylamine class of antimycotics or excipients in the formulation.
Chronic, hyperkeratotic plantar (moccasin) tinea pedis
Other fungal disease or intertrigo
Other abnormal findings on the affected foot
Systemic antifungal or antimicrobial treatment within the last 3 months
Topical treatment for skin lesions on feet within the last 3 months
Diabetes mellitus and peripheral artery occlusive disease
Intervention: Metformin Hydrochloride
Trial phase: Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.

metformin hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Men will be eligible to this study if they are diagnosed with a histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) treatable by prostatectomy and have a current PSA less than 50 ng/ml
Have not received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin =< 1.5 times institutional upper limits of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 times institutional ULN
Creatinine within normal institutional limits
Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Type I or type II diabetic patients on treatment with any drug for diabetes or participants with fasting glucose >= 126 mg/dL
History of impaired liver or kidney function
Participants with a current history of high alcohol consumption (> 3 standard drinks/day) or binge drinking (5 or more drinks) in one session of 1-3 hours
History of lactic acidosis or at increased risk for lactic acidosis such as patients with unstable or acute congestive heart failure who are at risk of hypoperfusion with hypoxemia
Participants may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical composition to metformin
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of acute or chronic metabolic acidosis
Concurrent use of cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)
Concurrent use of non-study metformin or other biguanides
Intervention: ASCORBIC ACID
Trial phase: Phase 1 | Phase 2
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Subject receives a high dose of infused Vitamin C

Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo
Eligibility criteria:
Inclusion Criteria:

systemic inflammatory response: fever (38°C or greater) or hypothermia (36°C or lower), tachypnea (20 breaths/min) or need for mechanical ventilation for an acute process, tachycardia (rate 90/min or more), white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 or more than 10% band forms.
Presumed or Known Site of Infection: Purulent sputum, chest radiograph with new infiltrate, spillage of bowel contents, radiographic or physical examination evidence of an infected collection, white blood cells in a normally sterile body fluid, positive blood culture, evidence of infected mechanical hardware by physical, radiographic, or ultrasonographic evidence.
Evidence of Dysfunction of One or More End Organs: cardiovascular dysfunction: mean arterial pressure 60 mm Hg or less, the need for vasopressors to maintain this pressure in the presence of adequate intravascular volume (central venous pressure 12 mmHg); respiratory failure: (arterial PO2-to-FiO2 ratio of less than 250 or less than 200 in the presence of pneumonia; renal dysfunction: Urine output ≤ 0.5 ml/kg/hr for 2 hours in the presence of adequate intravascular volume or doubling of the serum creatinine; hematologic dysfunction: thrombocytopenia ≤ 80,000 platelets/mm3 or 50% decrease from baseline during the acute illness; Unexplained metabolic acidosis: arterial pH ≤ 7.3 and a plasma lactate level higher than 2.5. Hepatic Dysfunction: Acute Serum transaminase elevation greater than five times normal.
Informed Consent: Ability to obtain informed consent within 48 hours.

Exclusion Criteria:

Demographic Characteristics: Children (age < 18 years), pregnant women, prisoners, and other wards of the state are excluded from participation in this study.
Informed Consent: Inability to obtain informed consent within 48 hours.
Cognitive Impairment: In the absence of family or next of kin, if the investigators feel the patient is cognitively impaired, and unable to provide informed consent, the patient will not be accessed to the study.
Non-English Speaking Patients: Patients who are non english speaking will not be accessed to this study.
Intervention: ASCORBIC ACID
Trial phase: Phase 1 | Phase 2
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Subject receives a low dose of infused Vitamin C

Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo
Eligibility criteria:
Inclusion Criteria:

systemic inflammatory response: fever (38°C or greater) or hypothermia (36°C or lower), tachypnea (20 breaths/min) or need for mechanical ventilation for an acute process, tachycardia (rate 90/min or more), white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 or more than 10% band forms.
Presumed or Known Site of Infection: Purulent sputum, chest radiograph with new infiltrate, spillage of bowel contents, radiographic or physical examination evidence of an infected collection, white blood cells in a normally sterile body fluid, positive blood culture, evidence of infected mechanical hardware by physical, radiographic, or ultrasonographic evidence.
Evidence of Dysfunction of One or More End Organs: cardiovascular dysfunction: mean arterial pressure 60 mm Hg or less, the need for vasopressors to maintain this pressure in the presence of adequate intravascular volume (central venous pressure 12 mmHg); respiratory failure: (arterial PO2-to-FiO2 ratio of less than 250 or less than 200 in the presence of pneumonia; renal dysfunction: Urine output ≤ 0.5 ml/kg/hr for 2 hours in the presence of adequate intravascular volume or doubling of the serum creatinine; hematologic dysfunction: thrombocytopenia ≤ 80,000 platelets/mm3 or 50% decrease from baseline during the acute illness; Unexplained metabolic acidosis: arterial pH ≤ 7.3 and a plasma lactate level higher than 2.5. Hepatic Dysfunction: Acute Serum transaminase elevation greater than five times normal.
Informed Consent: Ability to obtain informed consent within 48 hours.

Exclusion Criteria:

Demographic Characteristics: Children (age < 18 years), pregnant women, prisoners, and other wards of the state are excluded from participation in this study.
Informed Consent: Inability to obtain informed consent within 48 hours.
Cognitive Impairment: In the absence of family or next of kin, if the investigators feel the patient is cognitively impaired, and unable to provide informed consent, the patient will not be accessed to the study.
Non-English Speaking Patients: Patients who are non english speaking will not be accessed to this study.
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 0.5 mg/kg body weight/day

Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day
Eligibility criteria:
Inclusion Criteria:

Male or female over 1 years old
Subject has confirmed diagnosis of Smith-Lemli-Opitz Syndrome
Subject is currently receiving cholesterol supplementation

Exclusion Criteria:

Subjects too ill to travel to the study site
Subjects who are unable to safely undergo study procedures
Pregnant women
Intervention: Ranolazine
Trial phase: Phase 4
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.

Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets

Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.

QT Interval: Calculation of a QT interval will be performed throughout subject participation.
Eligibility criteria:
Inclusion Criteria:

18-74 years of age
Within 50% of ideal body weight and greater than 40 kg
Chronic kidney disease (CKD) stage 5 receiving maintenance hemodialysis for at least 3 months
Native kidney estimated glomerular filtration rate(GFR) < 10 mL/min
No concurrent illness or evidence of infection
Able to give informed consent

Exclusion Criteria:

QTc interval > 470 msec at echocardiogram (ECG) obtained within the last 6 months
Concomitant QT-prolonging drugs, major P-gp inhibitors, and CYP3A4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin
Pre-study hemoglobin < 9.5 g/dL
Plasma albumin < 2.5 g/dL
Liver disease - exclude subjects with a Child Pugh score of C or higher
Positive pregnancy test
Breastfeeding
Allergy to ranolazine
Participating in another investigational study
Hepatitis B infection due to dialysis isolation requirements
Unstable blood pressure control
Need for routine large fluid removal during dialysis (> 4L)
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: 151
Group description: Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Eligibility criteria:
Inclusion Criteria:

Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

Exclusion Criteria:

Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Ophthalmic solution containing olopatadine, 0.1%
Eligibility criteria:
Inclusion Criteria:

Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

Exclusion Criteria:

Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

Serum laboratory examination obtained at study entry:

Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
For women of childbearing age: negative serum beta HCG.
Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
Normal cognitive function.
Normal communicative ability (English).
Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
Signed informed consent.

Exclusion Criteria:

Pregnancy or breast-feeding.
Renal or hepatic dysfunction.
Significant cardiac disease (e.g. MI within 1 year).
Signs or symptoms of central neurological disorder, excluding SCI.
Severe psychological disorder requiring treatment.
Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
Chronic substance abuse, including alcohol.
Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Poor metabolizer of P450 2D6 substrates.
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

Serum laboratory examination obtained at study entry:

Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
For women of childbearing age: negative serum beta HCG.
Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
Normal cognitive function.
Normal communicative ability (English).
Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
Signed informed consent.

Exclusion Criteria:

Pregnancy or breast-feeding.
Renal or hepatic dysfunction.
Significant cardiac disease (e.g. MI within 1 year).
Signs or symptoms of central neurological disorder, excluding SCI.
Severe psychological disorder requiring treatment.
Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
Chronic substance abuse, including alcohol.
Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Poor metabolizer of P450 2D6 substrates.
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

Serum laboratory examination obtained at study entry:

Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
For women of childbearing age: negative serum beta HCG.
Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
Normal cognitive function.
Normal communicative ability (English).
Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
Signed informed consent.

Exclusion Criteria:

Pregnancy or breast-feeding.
Renal or hepatic dysfunction.
Significant cardiac disease (e.g. MI within 1 year).
Signs or symptoms of central neurological disorder, excluding SCI.
Severe psychological disorder requiring treatment.
Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
Chronic substance abuse, including alcohol.
Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Poor metabolizer of P450 2D6 substrates.