anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
Acceptable candidate for venipuncture and intravenous (iv) infusion
At least 1 partial seizure with motor component per 90 days
Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type

Exclusion Criteria:

Previous use of lacosamide
History of primary generalized seizures
History of status epilepticus within last 12 months
History of cluster seizures during 8 week period prior to screening
Non-epileptic events, including psychogenic seizures that could be confused with seizures
Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
Received any rescue benzodiazepines more than once during the 28 days prior to screening
Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
Prior or concomitant vigabatrin use
Intervention: Vardenafil
Trial phase: Phase 3
ATC code: G04BE09
SMILES: CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Eligibility criteria:
Inclusion Criteria:

Males 18 years-of-age or older.
Stable, heterosexual relationship for at least 6 months.
A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

Any underlying cardiovascular condition, including unstable angina pectoris
History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
Uncontrolled atrial fibrillation / flutter at screening
History of congenital QT prolongation
History of surgical prostatectomy due to prostate cancer
Hereditary degenerative retinal disorders
History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
Presence of penile anatomical abnormalities
Spinal cord injury
Resting or postural hypotension or hypertension
Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
Subjects who have been confirmed with phenylketonuria (PKU).
Use of any treatment for ED within 7 days of Visit 1.
Intervention: Capsaicin
Trial phase: Phase 4
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: 0.1% Topical Capsaicin cream was applied to one forearm.

A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application.
Eligibility criteria:
Inclusion Criteria:

Adult men and women who are between 18 and 50 years of age.
Subjects must be in general good health with no skin disease, disease state or physical condition which would impair evaluation of pain perception or which would increase their health risk by study participation as determined by the investigators.
Women of childbearing potential will be required to have a negative pregnancy test in order to enroll in the study.

Exclusion Criteria:

Adults over age 50.
Children less than 18 years of age.
Unable to complete the required measures.
Diagnosis of diseases that would affect the measurement of pain perception.
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 30 days prior to study participation.
Use of oral analgesic or other medications known to interfere with pain perception in the week prior to the study.
Use of emollient on the forearms on the day of the study visit.
Use of medicated topical preparations on the forearms for the week prior to the study.
Known history of neuropathy causing diseases such as uremia.
Known history of uncontrolled thyroid disease.
Known history of diabetes mellitus.
Allergy to capsaicin.
Pregnant women.
Intervention: Alogliptin
Trial phase: Phase 3
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Eligibility criteria:
Inclusion Criteria

Diagnosis of type 2 diabetes
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
Fasting plasma glucose less than 13.3 mmol per L.
Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

History of type 1 diabetes.
History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
Hemoglobin less than 120 g per L for males and less than100 g per L for females.
Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Serum creatinine level greater than 133 μmol per L.
Fasting total cholesterol greater than 6.5 mmol per L.
New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
History of acute metabolic diabetic complications.
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with human immunodeficiency virus.
History of diabetic gastro paresis.
History of gastric bypass surgery.
Intervention: Alogliptin
Trial phase: Phase 3
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Eligibility criteria:
Inclusion Criteria

Diagnosis of type 2 diabetes
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
Fasting plasma glucose less than 13.3 mmol per L.
Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

History of type 1 diabetes.
History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
Hemoglobin less than 120 g per L for males and less than100 g per L for females.
Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Serum creatinine level greater than 133 μmol per L.
Fasting total cholesterol greater than 6.5 mmol per L.
New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
History of acute metabolic diabetic complications.
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with human immunodeficiency virus.
History of diabetic gastro paresis.
History of gastric bypass surgery.
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively

N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Eligibility criteria:
Inclusion Criteria:

Elective lung resection for cancer

Exclusion Criteria:

Age less than 18 years
Women of child-bearing age or potential
Known allergy to N-acetylcysteine
Oral steroid in the preceding 1 month
N-acetylcysteine in the preceding 1 month
Unable to receive standardised anaesthetic approach
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively

0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Eligibility criteria:
Inclusion Criteria:

Elective lung resection for cancer

Exclusion Criteria:

Age less than 18 years
Women of child-bearing age or potential
Known allergy to N-acetylcysteine
Oral steroid in the preceding 1 month
N-acetylcysteine in the preceding 1 month
Unable to receive standardised anaesthetic approach
Intervention: Raltegravir
Trial phase: Phase 2
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Immediate switch of PI or NNRTI to Raltegravir
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or plasma HIV-1 RNA > 2000 on two occasions,
Female subjects 18 years or older
Documented central fat accumulation (defined by waist circumference of > 94 cm or a waist to hip ratio of > 0.88).
Documented HIV RNA <50 copies/mL at screening and <400 copies/mL in the past 6 months.
Current antiretroviral therapy with two nucleoside analogues and either a non-nucleoside analogue (nevirapine, efavirenz or TMC125) or an approved protease inhibitor. Patients on NNRTI+PI at study entry will be excluded. Study participants do not need to be on their first regimen. No changes in ART in the 12 weeks prior to screening. The nucleoside backbone must include either tenofovir or abacavir and either lamivudine or emtricitabine. Fixed dose combinations with emtricitabine or abacavir are allowed.
For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

Pregnancy: current or within the past 6 months or breast feeding
Prior treatment history that would preclude the use of emtricitabine or abacavir as the nucleoside backbone during study treatment
Current use of metformin or thiazolidinediones.
Use of growth hormone or growth hormone releasing factor in the last 6 months before screening.
Change or initiation of anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is allowed.
Current use of androgen therapy.
Intent to modify diet, exercise habits or to enroll in a weight loss intervention during the study period.
Current or projected need to use rifampin, dilantin or phenobarbital during the 48-week study period.

Laboratory values at screening of

ANC >500 cells/mm3
Hemoglobin <10 gm/dl
CrCl > 60 ml/min (estimated by Cockcroft-Gault equation)
AST or ALT > 3 x ULN
Intervention: Raltegravir
Trial phase: Phase 2
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or plasma HIV-1 RNA > 2000 on two occasions,
Female subjects 18 years or older
Documented central fat accumulation (defined by waist circumference of > 94 cm or a waist to hip ratio of > 0.88).
Documented HIV RNA <50 copies/mL at screening and <400 copies/mL in the past 6 months.
Current antiretroviral therapy with two nucleoside analogues and either a non-nucleoside analogue (nevirapine, efavirenz or TMC125) or an approved protease inhibitor. Patients on NNRTI+PI at study entry will be excluded. Study participants do not need to be on their first regimen. No changes in ART in the 12 weeks prior to screening. The nucleoside backbone must include either tenofovir or abacavir and either lamivudine or emtricitabine. Fixed dose combinations with emtricitabine or abacavir are allowed.
For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

Pregnancy: current or within the past 6 months or breast feeding
Prior treatment history that would preclude the use of emtricitabine or abacavir as the nucleoside backbone during study treatment
Current use of metformin or thiazolidinediones.
Use of growth hormone or growth hormone releasing factor in the last 6 months before screening.
Change or initiation of anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is allowed.
Current use of androgen therapy.
Intent to modify diet, exercise habits or to enroll in a weight loss intervention during the study period.
Current or projected need to use rifampin, dilantin or phenobarbital during the 48-week study period.

Laboratory values at screening of

ANC >500 cells/mm3
Hemoglobin <10 gm/dl
CrCl > 60 ml/min (estimated by Cockcroft-Gault equation)
AST or ALT > 3 x ULN
Intervention: Progesterone
Trial phase: Phase 4
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 468
Group description: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
Eligibility criteria:
Inclusion Criteria:

Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml
Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria:

Women who have had more than 3 previous IVF/ET cycles
Intervention: Progesterone
Trial phase: Phase 4
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 468
Group description: Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.

.
Eligibility criteria:
Inclusion Criteria:

Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml
Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria:

Women who have had more than 3 previous IVF/ET cycles
Intervention: Simvastatin
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
Eligibility criteria:
Inclusion Criteria:

1. Patients scheduled for elective major spine surgery (multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation)

Exclusion Criteria:

Pregnancy
Lactating females
Oral or parenteral corticosteroid use in the past 30 days
Elevation of AST or ALT > 3x normal
Elevation of creatinine kinase > 2x normal
Previous adverse drug reaction to any medication in the statin class
Current use of fibrates, niacin, itraconazole, ketoconazole, macrolide antibiotics, HIV protease inhibitors and/or nefazodone
Active liver disease
Current statin use

Anti-inflammatory use of the following medications within the last 30 days:

Sulfasalazine
Mycophenolate
Cyclosporine
Cyclophosphamide
Azathioprine
Chlorambucil
Minocycline
Myochrysine
Penicillamine
Hydroxychloroquine
Leflunomide
Any medications listed in 3 or 10 above in the post-operative period
Use of Activated protein C at any time during the patients hospitalization

Use of anti-inflammatory medications listed below within the last 30 days:

Leflunomide
Sulfasalazine
Mycophenolate
Cyclosporine
Cyclophosphamide
Azathioprine
Chlorambucil
Minocycline
Myochrysine
Penicillamine
Hydroxychloroquine
Methotrexate
Intervention: rhEPO
Trial phase: Phase 3
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (IPSS): refractory anemia with excess of blasts (RAEB) or RAEB in transformation [RAEB-t]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at MD Anderson Cancer Center.
Patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
Patients with documented iron, vitamin B12, or folate deficiency are eligible, but should receive replacement therapy while on study.
Understand and voluntarily sign an informed consent form.

Exclusion Criteria:

Patients with prior treatment with any form of erythropoietin within the previous month.
Patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
New onset (within 3 months prior to randomization) or poorly controlled seizures.
Patients with known hypersensitivity to the active substance or any of the excipients.
Pregnant or lactating women.
Acute Erythroleukemia (M6 French-American-British (FAB) classification)
Hemoglobin greater than or equal to 10g/dl
Patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (ESAs) were given to maintain hemoglobin levels of more than 12 g/dL.
Patients with metastatic breast cancer receiving chemotherapy when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
Patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
Patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking ESAs.