anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lenalidomide
Trial phase: Phase 1
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles.
Eligibility criteria:
Inclusion Criteria:

Subjects must be at least 18 years of age;
Subjects must be post-allogeneic transplant from any donor source;

Subjects must have either:

High risk CD34+ AML (de novo or secondary, and any WHO 2008 classification excluding acute promyelocytic leukemia). High risk AML is defined as (a) disease status beyond complete remission (CR) #1 at transplant or (b) treatment related AML or (c) presence of adverse cytogenetics including inv(3); t(3;3); t(6;9); t(v;11); -5 or del(5q); -7; abnl(17p) or complex karyotype; or
High risk CD34+ MDS (WHO 2008 classification). High risk is defined as (a) blast count ≥5% at the time of transplant or (b) treatment related MD or (c) presence of adverse cytogenetics including -7/del7q or complex karyotype;
For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;
For MDS subjects, they must have < 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT;
Subject Karnofsky performance status must be ≥ 70;
Subjects must be platelet transfusion independent (Platelet transfusion independence is defined as 7 days or greater without a platelet transfusion);
Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3;
Subjects must have total bilirubin ≤ 2 mg/dL;
Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal;
Subjects must have serum creatinine < 2.5 times upper limit of normal and a calculated creatinine clearance > 30 ml/min by Cockcroft-Gault formula (see Appendix I: Cockcroft-Gault Creatinine Clearance Calculation);
All study participants who will receive lenalidomide based on the CD34+ chimerism testing must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program;

Females of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) may participate, provided they meet the following conditions:

a) Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; and

Written, voluntary informed consent, willingness, and ability to comply with all study procedures.

Exclusion Criteria:

CD34- AML or MDS;
Inability to give informed consent;
Uncontrolled active infection(s) requiring intravenous antibiotics;
Known or suspected hypersensitivity to lenalidomide;
Grade II-IV acute GVHD or extensive GVHD;
Not able to swallow the lenalidomide capsule as a whole;
Female subjects who are pregnant or nursing.
Intervention: Fluoxetine
Trial phase: Phase 3
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 97
Group description: Fluoxetine capsules 20 mg. Oral administration, once per day.
Eligibility criteria:
Inclusion Criteria:

Male or Female outpatients between 7-17 years of age
Primary diagnosis of Major Depressive Disorder (MDD)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
History of suicidal behavior, or requires precaution against suicide
Not generally healthy medical condition
Seizure disorder
Intervention: Cilostazol
Trial phase: Phase 4
ATC code: B01AC23
SMILES: O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Administer Cilostazol100 mg twice daily for 90 days.

Cilostazol: 100 mg twice daily for 90 days
Eligibility criteria:
Inclusion Criteria:

At least 35 years of age
Atherosclerotic peripheral arterial disease
Able to provide informed consent
Lower extremity open or endovascular revascularization.

Exclusion Criteria:

Known CHF (class III/IV)
Allergic reaction to phosphodiasterase inhibitors
Intracranial bleeding within 3 months or active bleeding peptic ulcer disease
Traumatic vascular injuries requiring revascularization
Pregnant or breast feeding women or women who plan to get pregnant over the study period
Planned ipsilateral major amputation within 30 days of index procedure
Moderate to severe hepatic impairment.
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: 200 mg abemaciclib administered once, orally, to participants with normal hepatic function.
Eligibility criteria:
Inclusion Criteria:

Female participants must be of non-child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
Have known allergies to abemaciclib, related compounds, or any components of the formulation
No human immunodeficiency virus (HIV) infection or antibodies
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: 200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.
Eligibility criteria:
Inclusion Criteria:

Female participants must be of non-child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
Have known allergies to abemaciclib, related compounds, or any components of the formulation
No human immunodeficiency virus (HIV) infection or antibodies
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Eligibility criteria:
Inclusion Criteria:

Children aged 3-17,
weighing less than 50kg
present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
Treating physician determines the patient to require opioid analgesia.

Exclusion Criteria:

Children with facial trauma or any abnormal nasal anatomy;
developmentally delayed children;
children with head trauma/increased intracranial pressure (ICP);
children with known allergy to fentanyl or ketamine;
children who are unable to provide pain scale assessment;
children with chronic pain of greater than 4 weeks;
Pregnant females;
and children with a Glasgow Coma Scale (GCS)<15.
Intervention: Acetaminophen
Trial phase: Early Phase 1
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 114
Group description: Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment

paracetamol: Pre-operative administration of Paracetamol syrup
Eligibility criteria:
Inclusion Criteria:

healthy
in need of dental treatment with local anesthesia

Exclusion Criteria:

preoperative pain,
patients taking analgesics within 5 h prior to the dental treatment
allergic reaction or adverse effect to paracetamol
not available (by phone) at least 2 hours after treatment
patient refuse to drink the syrup
dental treatment without local anesthesia
Intervention: Bictegravir
Trial phase: Phase 1
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
Eligibility criteria:
Key Inclusion Criteria:

All Individuals:

Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

Individuals with impaired renal function

Chronic stable renal impairment without recent clinical change

Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min
Moderate: CrCl = 30 - 59 mL/min
Severe: CrCl = 15 - 29 mL/min

Healthy individuals

CrCl ≥ 90 mL/min

Key Exclusion Criteria:

All Individuals:

Pregnant or lactating females
HIV positive or chronic hepatitis B infected

Individuals with impaired renal function

Chronic liver disease
Dialysis or anticipated use of dialysis
Renal transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75
Ability to read and write in English (our post-operative pain log is only available in English)
Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)

Exclusion Criteria:

Answering yes to any of the following questions: "Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen"
History of cardiac arrhythmia
History of jaundice
Acute abdominal inflammatory or infectious process at time of surgery
Known malignancy at time of surgery
Known pregnancy at time of surgery
Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
>6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
Allergy to acetaminophen
Women who weigh less than 50 kilograms on the day of surgery.
Intervention: Aminolevulinic Acid Hydrochloride
Trial phase: Phase 4
SMILES: Cl.NCC(=O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments
Eligibility criteria:
Inclusion Criteria:

Must be able to understand and voluntarily sign an informed consent form
Must be male or female ≥ 18 years of age at the time of consent
Must be able to adhere to the study visit schedule and other protocol requirements
Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation

Exclusion Criteria:

Inability to provide voluntarily consent or mentally incompetent
Active herpes labialis lesions
Subjects with any condition 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
Subjects with any other skin condition that might affect the evaluation of the study disease
Pregnant or breastfeeding female subjects
Subjects who have used any investigational medication within one month prior to study entry
Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis
Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry
Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry
Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity
Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards, construction workers, frequent sunbed users, etc.)
Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
Subjects with a known hypersensitivity to Levulan
Subjects who are immunocompromised
Intervention: CALCIPOTRIENE
Trial phase: Early Phase 1
ATC code: D05AX02 | D05AX52
SMILES: C=C1/C(=C\C=C2/CCC[C@]3(C)[C@@H]([C@H](C)/C=C/[C@@H](O)C4CC4)CC[C@@H]23)C[C@@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects

topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
Age ≥ 18 years.
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
Subjects may not be receiving any investigational agents.
Subjects must not be pregnant or nursing.
Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
Stable CF disease as judged by the investigator.

Exclusion Criteria:

History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
Stable CF disease as judged by the investigator.

Exclusion Criteria:

History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.

Acetaminophen: Acetaminophen total dose of 1000mg
Eligibility criteria:
Inclusion Criteria:

English Speaking
Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion Criteria:

Acetaminophen allergy
Opioid dependency
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres
Eligibility criteria:
Inclusion Criteria:

Ability to understand and willingness to sign the written informed consent document
Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)
Patient is at least 18 years of age. No gender/race-ethnic restrictions.
Performance status (ECOG) between 0-3
History and Physical done within 4 weeks of enrollment.

Exclusion Criteria:

Patient has previously been enrolled in and completed this study.
Known right to left cardiac shunt, bidirectional or transient.
Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
History of hypersensitivity to the contrast agent perflutren
History of pulmonary hypertension
Patients who are pregnant or are trying to become pregnant
Intervention: Fluoxetine
Trial phase: Phase 3
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 134
Group description: Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Eligibility criteria:
Key Inclusion Criteria:

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Key Psychiatric Exclusion Criteria:

DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol
Intervention: Metformin
Trial phase: Phase 4
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 | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.

Participants took metformin capsules 2 times daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Men and women;
age >60 years with IGT based on 75g OGTT (fasting plasma glucose < 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl);
this definition of IGT will include individuals with combined impaired fasting glucose (IFG) and IGT.

The investigators chose these inclusion criteria in order to study subjects who have evidence of impaired glucose regulation, but are not yet diabetic.

Exclusion Criteria:

Serious chronic or acute illness: cancer, clinically significant congestive heart failure, COPD, inflammatory conditions, serum creatinine > 1.4 mg/dl (female) or > 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (>7 drinks in 24 hrs).
Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin)
Hypersensitivity to metformin or any component of the formulation