anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lurasidone
Trial phase: Phase 3
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and is 18 to 75 years of age inclusive.
Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Has a lifetime history of at least one bipolar manic or mixed manic episode.
Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than Bipolar I Disorder).
Hospitalization for a manic or mixed episode within the past two months.
Used investigational compound within past 6 months.
Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
Intervention: Bupropion Hydrochloride
Trial phase: Phase 2
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Group receiving bupropion SR medication

Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days

- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment
Eligibility criteria:
Inclusion Criteria:

Pregnant women ≥ 18 years of age
Gestational age between 14 and 26 weeks confirmed by ultrasound
Currently smoking ≥ 5 cigarettes per day

Exclusion Criteria:

Abnormal liver function tests
History of or current seizure disorder or closed head injury with loss of consciousness
Known hypersensitivity to bupropion
Any psychiatric disorder requiring psychotropic medication
Current anorexia or bulimia
Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks
Major Depressive Disorder or current suicidal risk
Use of any illicit substances since receiving knowledge of pregnancy
Regular use of alcohol (>1 drink/week on average)
Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus
Twins or other multiple gestation
Fetal abnormality on the 14 week ultrasound
Plans to deliver at a hospital other than Memorial Hermann
Inability to communicate with research staff or make study visits due to lack of phone or transportation access
Participation in another clinical study which may affect study outcomes
Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)
Intervention: Naftifine Hydrochloride
Trial phase: Phase 3
SMILES: CN(CC=Cc1ccccc1)Cc1cccc2ccccc12.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 572
Group description: Topical; applied once daily for two weeks
Eligibility criteria:
Inclusion Criteria:

Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).

Exclusion Criteria:

Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.
Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
Subjects with a known hypersensitivity to study drugs or their components.
Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
Uncontrolled diabetes mellitus.
Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Current diagnosis of immunocompromising conditions.
Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
Extremely severe tinea pedis (incapacitating).
Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Eligibility criteria:
Inclusion Criteria:

An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Intervention: Ergocalciferol
Trial phase: Phase 4
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Eligibility criteria:
Inclusion Criteria:

History of nephrolithiasis as per medical record
Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
25(OH)D deficiency or insufficiency (defined as a serum level < 30 ng/ml) within 3 months of enrollment

Exclusion Criteria:

Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
Hypercalcemia (serum calcium > 10.4 mg/dL) at baseline
Acute stone event or gross hematuria (blood in the urine) within the past 2 months
Recent stone intervention within the past 1 month
Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
Intervention: Oxygen
Trial phase: Phase 1
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included.

Exclusion Criteria:

Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are excluded.
Intervention: Oxygen
Trial phase: Phase 1
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included.

Exclusion Criteria:

Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are excluded.
Intervention: CID 21195079
Trial phase: Phase 3
SMILES: [Zn+2].[Zn+2].[Zn+2].[Zn+2]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.

Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.

No serious effect reported.
Eligibility criteria:
Inclusion Criteria:

Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.

Exclusion Criteria:

Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.
Intervention: Misoprostol
Trial phase: Not Applicable
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 85
Group description: Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
Eligibility criteria:
Inclusion Criteria:

14 years old or older
Negative pregnancy test
No prior pregnancies lasting beyond 19 6/7 weeks
Minimum 2 weeks after spontaneous or medical abortion
Minimum 4 weeks post 2nd trimester or surgical abortion
No previous IUD insertions
No PID in last 3 months
No current cervicitis
Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

Active cervical infection
Current pregnancy
Prior pregnancy beyond 19 6/7 weeks gestation
Known uterine anomaly
Fibroid uterus distorting uterine cavity
Copper allergy/Wilson's Disease (for Paragard)
Undiagnosed abnormal uterine bleeding
Cervical or uterine cancer
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[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 be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% 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: CID 118984462
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(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)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: 110
Group description: Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Exclusion Criteria:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
Intervention: CID 118984462
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(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)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: 111
Group description: Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Exclusion Criteria:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
Intervention: Valganciclovir
Trial phase: Phase 2
ATC code: J05AB14
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date

Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date
Eligibility criteria:
Inclusion criteria:

Any person approved as a kidney transplant donor with a recipient who has never undergone a previous transplantation
Kidney transplant donor must be 18 years old or older
The kidney transplant donor must be positive for CMV IgG and / or EBV IgG
The donor must be to a recipient that is discordantly seronegative for the virus for which the donor is seropositive (D+ R-)
They must have provided signed informed consent
The potential donors must be willing to contribute samples of blood and oral washings at regular intervals
The potential donor must state willingness to use effective contraception during treatment and 30 days following receiving the study drug/placebo
All females must have a negative pregnancy test
Person must have estimated creatinine clearance (Cockcroft and Gault method) >= 60 ml/min
Person must have Absolute neutrophil count >= 1000 cells/uL
Person must have Platelets >= 100,000/uL
Person must have Hemoglobin >= 9.5 g/dL

Exclusion criteria:

Any potential kidney transplant donor who is seronegative for both CMV & EBV IgG
Any potential kidney transplant donor who is receiving or have received anti-herpes medication in the past week
Any potential kidney transplant donor to a recipient who has received a previous solid organ transplant
Any potential kidney transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
Any potential kidney transplant donor who is breast feeding during the study
Any potential kidney transplant donor who is on corticosteroids