anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Idebenone
Trial phase: Phase 3
ATC code: N06BX13
SMILES: COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Following the body weight, patients will be allocated to one of the following regimen:

Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals

Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals

Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).
Eligibility criteria:
Inclusion Criteria:

Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
Patients who in the opinion of the investigator are able to comply with the requirements of the study
Body weight ≥ 25kg
Negative urine pregnancy test

Exclusion Criteria:

AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
Parallel participation in another clinical drug trial
Pregnancy or breast-feeding
Abuse of drugs or alcohol
Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study
Intervention: Lipoic acid
Trial phase: Phase 1 | Phase 2
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Oral administration three times daily (morning, mid-day, night)

Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.
Eligibility criteria:
Inclusion Criteria

Diagnosis of Breast cancer.

Breast cancer must meet the following criteria:

Early stage breast cancer (stages I, IIA) must be estrogen receptor (ER) positive AND low tumor grade (histopathologic grade 1 or 2)
Locally advanced breast cancer (LABC) (stages IIB, IIIA, IIB as defined by the Union for International Cancer Control and American Joint Committee on Cancer) must be ER positive, HER2 positive or HER2 negative, AND satisfy the following requirements: high endocrine responsiveness (defined as greater than 50% of tumor cells staining for hormone receptors), Grade 1 or 2 histological grade, less than 4 nodes positive, absence of extensive peritumoral vascular invasion, AND pathological tumor size less than 5 cm.
Inflammatory breast cancer (IBC) (stage IIIC)
Metastatic breast cancer (stage IV)
Must be receiving single agent paclitaxel in their prescribed chemotherapy regimen.
Age > 18 years. There is no upper age limit for participation in this study.
Required lab values: AST, ALT, creatinine
Women of childbearing potential and sexually active males must agree to use contraception while on study.
ECOG performance status 0,1,2
All patients must have given signed, informed consent.

Exclusion Criteria

Breast cancer meeting the following criteria:

Breast cancer stage 0
Early stage breast cancer (stages I, IIA) that is ER negative OR higher tumor grade (histopathologic grade greater than 2)
Stages I, II, and IIIA triple negative breast cancer (negative for estrogen receptors, progesterone receptors, and HER2)
LABC (stages IIB, IIIA, IIB) if they have low endocrine responsiveness (defined as less than 50% of tumor cells staining for hormone receptors), Grade 3 histological grade, 4 or more nodes positive, presence of extensive peritumoral vascular invasion, OR pathological tumor size greater than 5 cm
LABC (stages IIB, IIIA, IIB) that are ER negative
Evidence of pre-existing peripheral neuropathy as determined by baseline Michigan neuropathy screening instrument score > 2.
Previous chemotherapy treatment of any kind.
AST and ALT >2 times upper limit of normal; Creatinine > 2.0 mg/dL.
Current use of medications or substances known to be associated with peripheral neuropathy.
Use of ALA or other anti-oxidant supplements during the prior three months.
Diabetes mellitus or use of medications known to lower blood sugar.
Participation in any other experimental trial.
Intervention: Methotrexate
Trial phase: Phase 1 | Phase 2
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Eligibility criteria:
INCLUSION CRITERIA:

Participant must be 18 years of age or older.
Participant must understand and sign the protocol's informed consent document.
Participant is willing to comply with the study procedures and return for all study visits.

Participant has chronic macular edema secondary to non-infectious panuveitis, posterior or intermediate uveitis in at least one eye (the study eye) that has:

not been responsive to conventional immunosuppressive therapy in the past 3 months; OR
recurred while on conventional immunosuppressive therapy.
Participant has central macular thickness of ≥ 270 microns in the study eye.
Participant has visual acuity of 20/400 or better (≥ 19 ETDRS letters) in the study eye.
Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening and must be willing to undergo serum pregnancy tests throughout the study.

Both female participants of childbearing potential (see Appendix 1 for definition) and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for six months after the last study medication injection. Acceptable methods of contraception include:

hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (tubal ligation).

EXCLUSION CRITERIA:

Participant is in another investigational study and actively receiving investigational therapy for macular edema.
Participant has evidence of infectious panuveitis, posterior or intermediate uveitis in either eye.
Participant is expected to need ocular surgery in the study eye during the course of the trial.
Participant had intraocular surgery in the study eye within the past 90 days.
Participant had an injection of bevacizumab or ranibizumab within the past four weeks in the study eye.
Participant had an injection of triamcinolone within the past six weeks in the study eye.
Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study.
Participant has significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.
Participant has a confirmed positive serologic and/or molecular test for HIV-1/2.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age and may be of any race and either gender;

Subjects must not have ever used topical prostaglandin anti-glaucomatous therapy;

Subject has not used anti-glaucomatous treatment in the past 30 days and has not been using prescribed anti-glaucomatous medication for more than 6 months.
Subject is using other topical anti-glaucomatous topical treatment and wants to switch to a prostaglandin (must have undergone 30 day washout period)
The IRB Approved informed consent and the privacy document must be read, signed, and dated by the subject or legally authorized representative before enrollment. Additionally, the informed consent document must be signed and dated by the individual consenting the subject, as well as signed and dated by a witness, if applicable;
Subjects must be generally healthy and have normal ocular health; and
Subjects must be willing to follow the study procedures and visit schedule.

Exclusion Criteria:

Subjects must not have known sensitivities to any ingredient in any of the test articles

Subjects must not have any systemic or ocular disease or disorder (exc refractive error), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study:

No prior (within 30 days of enrollment) or current ocular infections (bacterial, viral or fungal), active ocular inflammation (i.e., follicular conjunctivitis, allergic conjunctivitis, iritis), glaucoma, or preauricular lymphadenopathy.
No clinically significant lash or lid abnormality (e.g., trichiasis, entropion or ectropion).
No uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis.).
No prior (within 7 days of enrollment) or current, unstable active illness (e.g., upper respiratory infection).
Pregnant woman
Subjects must not have history of ocular surgery/trauma within the last 6 months
Subjects must not have used any topical ocular or systemic antibiotics within 30 days of enrollment continuing throughout the study
Subjects must not have used any topical ocular or systemic corticosteroids within 30 days of enrollment continuing throughout the study
Subjects must not have used immunomodulator medications within 30 days of enrollment continuing throughout the study
Subjects must not have a immune cell density of >60/fame present at their baseline confocal scan
Subjects must not have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Inability to cooperate with the confocal exam
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
Naïve to treatment with fingolimod.

Exclusion Criteria:

A manifestation of MS other than those defined in the inclusion criteria.
A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Alogliptin/metformin
Trial phase: Phase 2 | Phase 3
SMILES: CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.
Intervention: Alogliptin/metformin
Trial phase: Phase 2 | Phase 3
SMILES: CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.
Intervention: Metformin
Trial phase: Phase 2 | Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.
Intervention: Alogliptin/metformin
Trial phase: Phase 2 | Phase 3
SMILES: CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.
Intervention: Alogliptin/metformin
Trial phase: Phase 2 | Phase 3
SMILES: CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.
Intervention: Dopamine
Trial phase: Not Applicable
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy
Eligibility criteria:
Inclusion Criteria:

Infants less than 24 hours of age
Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
Not initiated on any continuous pressor therapy prior to enrollment
Intravenous line in place
Outborn infants meeting eligibility criteria

Exclusion Criteria:

Infants not meeting eligibility criteria
Infants with life-threatening congenital defects
Infants with congenital hydrops
Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).
Intervention: Dalcetrapib
Trial phase: Phase 3
SMILES: CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
Eligibility criteria:
Inclusion Criteria:

Adult patients, >/=45 years of age
Patients admitted to the hospital for acute coronary syndrome (ACS)
Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion Criteria:

Symptomatic congestive heart failure (NYHA Class III or IV)
Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
Uncontrolled hypertension
Uncontrolled diabetes
Severe anemia
Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)