anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: One 25 mg tablet once daily for 54 weeks
Eligibility criteria:
Inclusion Criteria:

Participant has T2DM.
Participant is on dialysis on day of signing informed consent.
Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.

Exclusion Criteria:

Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Participant has cirrhosis or active liver disease.
Participant has been on dialysis for < 6 months.
Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
Participant has severe active peripheral vascular disease.
Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
Participant is under treatment for hyperthyroidism.
Participant has a hypersensitivity or contraindication to glipizide.
Intervention: Humalog
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 229
Group description: Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes mellitus for at least 1 year.
Are greater than or equal to 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

Exclusion Criteria:

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 229
Group description: Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes mellitus for at least 1 year.
Are greater than or equal to 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

Exclusion Criteria:

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Intervention: Bupropion
Trial phase: Phase 4
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
Eligibility criteria:
Inclusion Criteria:

Are between ages 18-65 years old.
Meet DSM-IV criteria for nicotine dependence.
Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath CO level > 10.
At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
Receive a score of ≥ 10 on the Insomnia Severity Index (ISI)
Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

Are taking an over-the-counter or prescription medications that are known to affect sleep.
Are taking medications contraindicated for use with eszopiclone or bupropion including: Ketoconazole, Itraconazole, Clarithromycin, Erythromycin, Nefazodone, Troleandomycin, Ritonavir, Nelfinavir, Trazodone, and Methadone.
Are using any over-the-counter analgesics that contain caffeine.
Have serious medical disorders that may make participation in the trial unsafe.
Are physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) in the past 6 months prior to randomization into the trial.
Consume greater than 1 alcoholic beverage per day or greater than 7 alcoholic drinks per week.
Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history bipolar disorder, schizophrenia, or anorexia or bulimia nervosa. Have a past history of major depression, with historical evidence of suicidal or homicidal behavior, or psychotic symptoms.
Have the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial.
Are from the same household as another study participant.
A history of seizures of any etiology.
A history of hypersensitivity to bupropion or Lunesta (eszopiclone).
Intervention: Zoely
Trial phase: Phase 3
SMILES: CC(=O)OC1(C(C)=O)CCC2C3C=C(C)C4=CC(=O)CCC4C3CCC21C.CC12CCC3c4ccc(O)cc4CCC3C1CCC2O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1591
Group description: Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual

period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
Eligibility criteria:
Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use condoms.
Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles).
At least 18 but not older than 50 years of age at the time of screening.
Body mass index (BMI) of >/= 17 and </= 35.
Good physical and mental health.
Willing to give informed consent in writing.

Exclusion Criteria:

Contraindications for contraceptive steroids.
In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional

contraindications related to the antimineralocorticoid activity of drospirenone

(conditions that predispose to hyperkalemia):

Renal insufficiency
Hepatic dysfunction
Adrenal insufficiency
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],

Squamous Intraepithelial Lesion [SIL], carcinoma in situ, invasive carcinoma) at screening.

Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.
Before spontaneous menstruation has occurred following a delivery or abortion.
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Intervention: Zoely
Trial phase: Phase 3
SMILES: CC(=O)OC1(C(C)=O)CCC2C3C=C(C)C4=CC(=O)CCC4C3CCC21C.CC12CCC3c4ccc(O)cc4CCC3C1CCC2O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
Eligibility criteria:
Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index = 17 and = 29 kg/m^2;
Good physical and mental health;
Willing to give informed consent in writing

Exclusion Criteria:

Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
Contraindications for contraceptive steroids
Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Intervention: Ovral
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg

ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.
Eligibility criteria:
Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index = 17 and = 29 kg/m^2;
Good physical and mental health;
Willing to give informed consent in writing

Exclusion Criteria:

Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
Contraindications for contraceptive steroids
Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Intervention: Zoely
Trial phase: Phase 3
SMILES: CC(=O)OC1(C(C)=O)CCC2C3C=C(C)C4=CC(=O)CCC4C3CCC21C.CC12CCC3c4ccc(O)cc4CCC3C1CCC2O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
Eligibility criteria:
Inclusion Criteria:

Willing to use COC for at least 6 cycles.
18 - 35 years of age at screening.
Body Mass Index (BMI) of >/= 17 and </= 35.
Good physical and mental health.
Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
Willing to give informed consent.

Exclusion Criteria:

Contraindications for contraceptive steroids (general).
Additional contraindications (renal, hepatic or adrenal insufficiency).
Breastfeeding.
Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex

steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).

Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Intervention: Doxycycline
Trial phase: Phase 2
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months

doxycycline monohydrate: 50mg once daily for 24 months
Eligibility criteria:
Inclusion Criteria:

age ≥ 18 years old
diagnosis of type 1 or type 2 diabetes mellitus
have a hemoglobin A1c less than 11% at pre-qualification visit
able and willing to give informed consent
best-corrected ETDRS visual acuity in study eye ≥ 49 letters (20/100)
severe non-proliferative diabetic retinopathy (ETDRS level 53E) or retinal and/or optic disk neovascularization less than the "high-risk" characteristics defined by the Diabetic Retinopathy Study (ETDRS level61- 65), and in whom panretinal photocoagulation is not imminently required in the ophthalmologist's judgment
able to perform reliable visual field and dark adaptation testing
central subfield thickness on OCT of ≤ 275microns
foveal fixation present in each eye (assessed by fundus photography using an internal fixation pointer or assessed by the investigator)
media clarity and pupil dilation sufficient for high-quality fundus photographs and fluorescein angiograms

Exclusion Criteria:

high-risk neovascularization in study eye
prior panretinal photocoagulation in the study eye
focal/grid laser photocoagulation in the macula within the past 15 weeks in the study eye
intraocular pressure > 22mmHg by Goldmann Tonometry in the study eye
history of pars plana vitrectomy in the study eye
vitreous or pre-retinal hemorrhage in the study eye
systemic or intravitreal anti-VEGF agent to the study eye or the fellow eye within the past 3 months
peribulbar steroid injection to the study eye or the fellow eye within the past 6 months
intravitreal triamcinolone acetonide to the study eye within the past 4 months
expectation by the investigator that retinal photocoagulation or other treatment for diabetic retinopathy (e.g. focal/grid laser to study eye, intravitreal triamcinolone acetonide to study eye, intravitreal anti-VEGF agent to study or fellow eye, ruboxistaurin or systemic anti-VEGF agent for diabetic macular edema) will be administered in the subsequent 24 months
an ocular condition (other than diabetes) is present in the study eye that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc)
anticipated need for cataract surgery in the study eye in the subsequent 24 months in the opinion of the investigator
history of major ocular surgery (including cataract surgery, scleral buckle, any intraocular surgery, etc) in the study eye within prior 6 months or anticipated within the subsequent 24 months following randomization
aphakia in the study eye
history of YAG capsulotomy performed in the study eye within 2 months prior to randomization