anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Afamelanotide
Trial phase: Phase 2
ATC code: D02BB02
SMILES: CCCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
Eligibility criteria:
Inclusion Criteria:

Male or female subjects with characteristic photosensitivity of EPP symptoms and positive diagnosis of EPP confirmed by laboratory result of elevated total protoporphyrin IX.
Aged 18 years old and above (inclusive).
Able to understand and sign the written Informed Consent Form.
Willing to take precautions to prevent pregnancy until completion of the study (Day 180).

Exclusion Criteria:

Any allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the study medication
EPP patients with significant hepatic involvement
Personal history of melanoma or dysplastic nevus syndrome.
Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
Any other photodermatosis such as PLE, DLE or solar urticaria.
Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.
Acute history of drug or alcohol abuse (in the last 6 months).
Patient assessed as not suitable for the study in the opinion of the Investigator (e.g. noncompliance history, allergic to local anesthetics, faints when given injections or giving blood).
Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Prior and concomitant therapy with medications which may interfere with the objectives of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the screening visit.
Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
Intervention: Pregabalin
Trial phase: Not Applicable
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
Eligibility criteria:
Inclusion Criteria:

Healthy ocular status
Stable preoperative refractive anisometropia
Consented to the PRK surgical procedure

Exclusion Criteria:

Pregnant or breastfeeding
Diagnosed with autoimmune disease or diabetes
Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
Patients only desiring PRK on one eye
Patients with history of drug use/abuse/addiction
Patients who are on chronic pain medications
Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
Patients with a history of suicidality
Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Group on active imatinib treatment

Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.
Eligibility criteria:
Inclusion Criteria:

Patients 18-65 years of age, diagnosed with asthma for at least 1 year;
Refractory asthma, defined as reporting that their asthma has not been completely controlled in the past 3 months despite continuous treatment with high-dose inhaled corticosteroids (ICS) and an additional controller medication, with or without continuous oral corticosteroids (OCS)

Exclusion Criteria:

Current smoking or smoking history of greater than 10 pack-years
Any other significant respiratory or cardiac disease, or the presence of clinically important comorbidities, including uncontrolled diabetes, uncontrolled coronary artery disease
If subject cannot undergo bronchoscopy procedure due to safety reasons
Previous treatment with Imatinib
A history of acute heart failure or chronic left sided heart failure
Uncontrolled systemic arterial hypertension
History of major bleeding or intracranial hemorrhage
History of immunodeficiency diseases, including HIV
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
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.
Diagnosis of Hepatitis B or C.
History of alcohol abuse within 6 months of screening.
History of illicit drug abuse within 6 months of screening.
Regular use of anticoagulants (eg: Warfarin Sodium, Coumadin), amiodarone, carbamazepine, Cyclosporine, Rifampicin, or reverse transcriptase inhibitors
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 40 mg Simvastatin 1 pill every day for 30 days

Simvastatin: 40 mg, P.O.,daily for 30 days
Eligibility criteria:
Inclusion Criteria:

Male and females of all ethnic backgrounds ranging aged 18 to 70
Ages 18-70 yrs
Patients with congestive heart failure diagnosed on clinical history, a routine exercise test, echocardiography and/or routine cardiac catheterization, in functional class I-III
Patients with heart failure due to ischemic and non-ischemic etiologies
Normotensive and not taking blood pressure controlling medications

Exclusion Criteria:

Low blood pressure (<100/60)
End stage renal disease
Chronic Obstructive Pulmonary Disease (COPD) with concurrent daily use of inhalers
Peripheral neuropathy
Pregnant women
Intervention: Losartan Potassium
Trial phase: Not Applicable
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1.[K+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of ALL, LL, or Burkitt's receiving induction chemotherapy with Hyper-CVAD, any variant of Hyper-CVAD or augmented BFM at MD Anderson Cancer Center.
Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy.
Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer.

Exclusion Criteria:

Hemoglobin greater than or equal to 10 g/dL.
Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months.
Patients with known hypersensitivity to mammalian-cell derived products or to human albumin.
Uncontrolled hypertension
History of thrombotic vascular event.
Pregnant or lactating women.
Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies).
Intervention: Sitagliptin
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 16
Group description: All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).

Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
Eligibility criteria:
Inclusion Criteria:

All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause will be considered for inclusion into the study. The diagnosis of DKA will be established by standard criteria (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18 mmol/L, increased anion gap).
The hyperglycemic group will include patients with an admission plasma glucose > 400 mg/dL but without the presence of metabolic acidosis or ketosis.

Exclusion Criteria:

significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes;
recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;
bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;
pregnancy,
have an allergy to any component of metformin or sitagliptin.
Intervention: Bimatoprost
Trial phase: Phase 3
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 295
Group description: Bimatoprost 0.03% Ophthalmic Solution
Eligibility criteria:
Inclusion Criteria:

Patient has ocular hypertension or glaucoma in both eyes
Requires IOP-lowering therapy in each eye

Exclusion Criteria:

Active or recurrent eye disease that would interfere with interpretation of study data in either eye
History of any eye surgery or laser in either eye within 6 months
Required chronic use of other eye medications during the study
Anticipated wearing of contact lenses during the study.
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Budesonide-MMX 9 mg tablet

Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent
Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission
Diagnosis of ulcerative colitis of mild to moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland
Females of child-bearing potential must have had a serum pregnancy test performed at the Final Visit of the parent study, and must use an acceptable contraceptive method throughout the treatment period. Female subjects must also not be actively breast-feeding through the entire study period.
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
Ability to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion Criteria:

Did not complete study CB-01-02/01
Achieved clinical remission in study CB-01-02/01
Patients with severe ulcerative colitis (UCDAI >10)
Patients with infectious colitis
Evidence or history of toxic megacolon
Severe anemia, leucopenia, or granulocytopenia
Use of immunosuppressive agents in the last 8 weeks before the study
use of anti-tumor necrosis factor alpha agents in the last three months
Concomitant use of any rectal preparation for the treatment of ulcerative colitis
Concomitant use of antibiotics
Concurrent use of cytochrome P-450 3A4 (CYP3A4) inducers and CYP3A4 inhibitors.
Patients with verified, presumed of expected pregnancy or ongoing lactation
Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency and/or severe impairment of the bio-humoral parameters (i.e., 2x upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or creatinine)
Patients with severe disease(s) in other organs of systems
Patients with local of systemic complications of other pathological states requiring a therapy with corticosteroids and/or immunosuppressive agents
Patients diagnosed with Type 1 diabetes
Patients diagnosed with or with a family history of glaucoma
Patients with known hepatitis B, hepatitis C, or with human immunodeficiency virus (HIV), according to the local privacy policy
Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events
Intervention: Methylphenidate
Trial phase: Phase 2
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Eligibility criteria:
Inclusion Criteria:

Clinically significant compulsive hoarding (Proposed DSM-V criteria) that is principal (i.e. currently most severe and needing of treatment) and has been present for at least one year.
At least moderate attentional difficulties.
Able to provide consent.
Patients can be on or off of serotonin reuptake inhibitors (SRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) but dose must be stable for 12 weeks prior to study.

Exclusion Criteria:

Currently taking any psychotropic medications other than SRIs or SNRIs.
Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder.
Current major depression is permitted if clearly secondary in importance to the hoarding.
Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors)
Any cardiovascular abnormality that increases the risk of participation, including significant history of cardiovascular disease or family history of sudden death.
Any medical or neurological disorder that increases the risk of participation or that is a medical contraindication for taking methylphenidate (e.g. glaucoma or Tourette's syndrome).
Current use of any drug that is contraindicated with methylphenidate (e.g. monoamine oxidase inhibitors).
Female patients who are pregnant or nursing.
Current or previous treatment with methylphenidate or CBT for hoarding.
Current ETOH/drug abuse or dependence disorder of dependency in the past 6 months.
Individuals with mild cognitive impairments, dementia, or significant intellectual deficits.
Intervention: Paroxetine Mesylate
Trial phase: Phase 3
SMILES: CS(=O)(=O)O.Fc1ccc(C2CCNCC2COc2ccc3c(c2)OCO3)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 285
Group description: Experimental

Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
Eligibility criteria:
Inclusion Criteria:

Female, >40 years of age
Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
Spontaneous amenorrhea for at least 12 consecutive months
Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

BMI ≥ 40 kg/m²
Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
History of self-injurious behavior
History of clinical diagnosis of depression; or treatment for depression
History of clinical diagnosis of borderline personality disorder
Use of an investigational study medication within 30 days prior to screening or during the study
Concurrent participation in another clinical trial or previous participation in this trial
Family of investigational-site staff
Intervention: Zopiclone
Trial phase: Early Phase 1
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Eszopiclone : 3mg tablet once prior to sleep
Eligibility criteria:
Inclusion Criteria:

18-64 years old
Untreated obstructive sleep apnea

Exclusion Criteria:

Nadir SaO2 <70% on a baseline PSG
Medications known to affect either sleep, breathing or muscle activity
Major co-morbidities apart from sleep apnea
Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
Women who are pregnant
Intervention: Ferrous Sulfate
Trial phase: Phase 3
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Oral intake

Iron Sulphate: Oral intake
Eligibility criteria:
Inclusion Criteria:

Men and women, aged more than 18 years.
Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
Hb < 11.0 g/dL (6.80 mmol/L)
Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).

Exclusion Criteria:

Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
Subjects with history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).
Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
Extensive active bleeding necessitating blood transfusion.
Planned elective surgery during the study.
Participation in any other clinical study within 3 months prior to screening.
Known intolerance to oral iron treatment.
Untreated B12 or folate deficiency.
I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
ESA treatment within 8 weeks prior to screening visit.
Serum ferritin > 500 µg/L.
Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Body weight < 30 kilograms.
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Borderline Personality Disorder
Current Major Depression

Exclusion Criteria:

Past 2 months SSRI use
Past 6 months non-SSRI antidepressant use
Past 2 months initiation of psychotherapy
Lifetime bipolar disorder, organic disorder, psychotic disorder
Current alcohol or drug dependence
Current severe suicidal / homicidal ideation necessitating immediate medical intervention
Currently pregnancy or nursing
Unable or unwilling to cooperate with study protocol
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Inert placebo (sugar pill) taken daily for eight weeks

Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Borderline Personality Disorder
Current Major Depression

Exclusion Criteria:

Past 2 months SSRI use
Past 6 months non-SSRI antidepressant use
Past 2 months initiation of psychotherapy
Lifetime bipolar disorder, organic disorder, psychotic disorder
Current alcohol or drug dependence
Current severe suicidal / homicidal ideation necessitating immediate medical intervention
Currently pregnancy or nursing
Unable or unwilling to cooperate with study protocol
Intervention: Ticlopidine
Trial phase: Phase 2
ATC code: B01AC05
SMILES: Clc1ccccc1CN1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
Eligibility criteria:
Inclusion Criteria:

Age older than 18 years
Scheduled for elective or ad-hos PCI
Aspirin use daily for greater or equal to one week
Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

Exclusion Criteria:

Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl
administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days
Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks
Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks
Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or hemoglobin <11 g per deciliter
Subjects who received full dose low molecular weight heparin within six hours prior to randomization
Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year
Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure