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: 200
Group description: 1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.

idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg
Eligibility criteria:
Inclusion Criteria:

Completion of 52 weeks in study SNT-III-001
Body weight ≥ 25 kg
Negative urine pregnancy test
Eligibility to participate in the present extension study as confirmed by investigator

Exclusion Criteria:

Safety or tolerability issues arising during the course of SNT-III-001 which in the opinion of the investigator preclude further treatment with idebenone
Clinically significant abnormalities of haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of SGOT, SGPT or creatinine
Parallel participation in another clinical drug trial
Pregnancy or breast-feeding
Abuse of drugs or alcohol
Intervention: Cisplatin
Trial phase: Phase 2
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Eligibility criteria:
Inclusion Criteria:

patients who were≥ 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were < 65 years of age and they had an ECOG PS 2
histologically confirmed non-small cell carcinoma
stages IIIB-IV disease
adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dL), and liver function (total bilirubin ≤1.5 mg/dL and serum transaminase level less than twice the upper limit of normal)
at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

Active infection
Prior chemotherapy, radiotherapy or surgery for their disease,
A history of myocardial infarction in the last 3 months before entry to the study
Uncontrolled congestive heart failure or hypertension
Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
All the patients provided written informed consent before they entered the study
Intervention: Flibanserin
Trial phase: Phase 3
ATC code: G02CX02
SMILES: O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 543
Group description: flibanserin 100mg po qd
Eligibility criteria:
Inclusion criteria:

Premenopausal women who are 18 years old and older
Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
Stable, monogamous heterosexual relationship for at least one year.
Willing to discuss sexual issues.
Willing to engage in sexual activity at least once a month
Normal pap smear
Must use medically acceptable method of contraception
Able to comply with daily use of a handheld entry device

Exclusion criteria:

Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
Partner with inadequately treated organic or psychosexual dysfunction
History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major life stress that could impair sexual function
Substance abuse
Intervention: Flibanserin
Trial phase: Phase 3
ATC code: G02CX02
SMILES: O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 468
Group description: flibanserin 100mg po qd

flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner
Eligibility criteria:
Inclusion criteria:

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
Stable, monogamous heterosexual relationship for at least one year
Willing to discuss sexual issues
Willing to engage in sexual activity at least once a month
Normal Pap smear
Normal mammogram
Normal uterine lining
Able to comply with daily use of handheld data entry device

Exclusion criteria:

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression
Suicidal behavior or ideation
Major life stress that could impair sexual function
Substance abuse
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Six patients will receive 2.5 mg oral daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of autistic spectrum disorder as defined by DSM-IV criteria.
Inflammatory CSF and serum markers with elevated level of TNF-Alfa (> 50pg/ml) or other Cytokine markers such as IL-1, IL-6 or MECP-1, or serum levels of such cytokines greater than 2X normal levels even in absence of CSF markers.

or

Patients with interictal epiliptiform EEG changes in the absences of clinical seizures, if CSF inflammatory markers are identified.
Patients will maintain any other baseline medications for autistic problems or EEG treatment as long as on these for prior 6-8 weeks with no dosage changes. Mentally impaired minors require a parent or legal guardian to sign the informed consent.

Exclusion Criteria:

-Diagnosis of PPD-NOS and other autism spectrum disorders.
Any serious medical condition, laboratory abnormality, genetic, brain, structural, or psychiatric illness that would prevent the subject from participating.
History of neutropenia, thrombocytopenia or other types of myelosuppression or risk factors for myelosuppression.
History or risk factors for thromboembolic events.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Current use of steroids (e.g. dexamethasone, prednisone), anthracyclines (Doxil, Adriamycin).
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Known positive for HIV or infectious hepatitis, type A, B or C or tuberculosis.
Intervention: Duract
Trial phase: Phase 4
SMILES: Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older.
Scheduled for cataract surgery by phacoemulsification.
Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis.
Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
No ocular use of prostaglandins within 2 weeks of surgery.
Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
Contraindications to NSAIDS.
Active ocular infection.
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 53
Group description: Acetaminophen, 10mg/kg

acetaminophen: Acetaminophen, 10mg/kg
Eligibility criteria:
Inclusion Criteria:

Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).

Exclusion Criteria:

Have inadequate intravenous access.
Have received antipyretic drug therapy within 2 hours before dosing.
Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.
Have a fever due to hyperthermia.
Pregnant or nursing.
Intervention: GLYCOPYRRONIUM
Trial phase: Phase 3
ATC code: A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 550
Group description: Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Eligibility criteria:
Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

Smoking history of at least 10 pack-years
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria:

Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Hydrocortisone
Trial phase: Phase 3
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Hydrocortisone: Applied once daily
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
Aged 6 to 17 years

Exclusion Criteria:

Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Intervention: Efavirenz
Trial phase: Phase 3
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 321
Group description: Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily
Eligibility criteria:
Inclusion Criteria:

HIV-1 positive by licensed diagnostic test
aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
50 < cluster of differentiation (CD)4 <500 cells/µL
No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case Definition (except pulmonary tuberculosis)
HIV RNA ≥1000 copies/mL
no prior exposure to antiretroviral therapy (ART) (including short course ART for preventing MTCT)
calculated creatinine clearance (CLCr) more than or equal to 50 mL/min (Cockcroft-Gault formula)
provision of written informed consent.

Exclusion Criteria:

the following laboratory values:

absolute neutrophil count (ANC) <500 cells/μL
hemoglobin <7.0 g/dL
platelet count <50,000 cells/μL
alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal
pregnant women or nursing mothers
active opportunistic or malignant disease not under adequate control
use of immunomodulators within 30 days prior to screening
use of any prohibited medications
current alcohol or illicit substance use that might adversely affect study participation
Intervention: Cisplatin
Trial phase: Not Applicable
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.

intracavitary balloon brachytherapy

external beam radiation therapy

intensity-modulated radiation therapy

radiation therapy treatment planning/simulation

3-dimensional conformal radiation therapy

Cisplatin
Eligibility criteria:
Inclusion Criteria:

Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer
Claustrophobic subjects must agree to be sedated during MRI procedures
ECOG performance status of 0-2

Exclusion Criteria:

Subjects with an inability to tolerate MR imaging
Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy
Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants
Women of childbearing potential who have a positive result on screening serum pregnancy test
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: This study was cancelled. No patients were enrolled in this group.
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

Exclusion Criteria:

History of hypersensitivity to any drugs or excipients of the study
Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
Neurological and hemodynamics disorders
Evidence of liver or kidney impairment or heart failure
Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Repaglinide
Trial phase: Phase 4
ATC code: A10BD14 | A10BX02
SMILES: CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 216
Group description: 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Lipid-lowing agent naïve
HbA1c: 6.5-8.5%
Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
Body Mass Index (BMI): 20-35 kg/m^2
Be able and willing to perform self-monitored plasma glucose (SMPG)
Be able and willing to eat 3 main meals per day
Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion Criteria:

Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
Previous participation in this study
Participation in a study of another investigational drug within 1 month prior to study start
Intervention: Tafluprost
Trial phase: Phase 3
ATC code: S01EE05
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/C(F)(F)COc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 320
Group description: One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Patient has a mean (or median) IOP of >=23 and =<36 in at least one eye at the 0800 hours time point at the Baseline Visit.
Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
Patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening)
Patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period
Patient has vision corrected to 20/80 or better in each eye
Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing through 24 hour after final dosing
Patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Patient is not pregnant and not planning to become pregnant during the study
Patient is male or female ≥18 of age on the day of signing the informed consent

Exclusion Criteria:

Patient is unable to use study medication in the affected eye(s)
Patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
Patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease
Patient has experienced significant visual field loss within the last year
Patient has had intraocular surgery in either eye in the last 4 months
Patient has a history of glaucoma surgery or refractive surgery in either eye
Patient is currently taking two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Patient has previously used tafluprost
Patient has a history of cardiovascular disorder within 6 months prior to screening
Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary disease, or abnormal chest x-ray
Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.