anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Diclofenac Potassium
Trial phase: Phase 4
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 years and over.
Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
Injury within past 12 hours.

Exclusion Criteria:

Pain medication was taken within the 6 hours that precede randomization.
During the past 3 months: Grade I-III sprain of the same ankle.
During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Intervention: Fluciclovine (18F)
Trial phase: Phase 2 | Phase 3
ATC code: V09IX12
SMILES: N[C@]1(C(=O)O)C[C@@H]([18F])C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.

FACBC: FACBC is given intravenously prior to PET scan
Eligibility criteria:
Inclusion Criteria:

Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA
ECOG/Zubrod Performance Status of 0-2
Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis
CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic disease outside of the pelvis
Willingness to undergo pelvic radiotherapy.

Exclusion Criteria:

Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic XRT)
Inability to undergo anti-3-[18F]FACBC PET-CT
Age under 18
Metastatic disease outside of pelvis on any imaging or biopsy
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

Severe acute co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 4
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 96
Group description: randomized to receive contraceptive implant at normal 6 week postpartum visit

Contraceptive implant
Eligibility criteria:
Inclusion Criteria:

Adolescents ages 14-24 attending prenatal care
Greater than 20 weeks estimated gestational age
English or Spanish-speaking
Desire to use the contraceptive implant for contraception postpartum
Anticipated delivery of a healthy infant vaginally or by cesarean.

Exclusion Criteria:

Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including

current or past history of thrombosis or thromboembolic disorders
hepatic tumors (benign or malignant)
active liver disease
undiagnosed abnormal genital bleeding
known or suspected carcinoma of the breast (or a personal history of breast cancer)
hypersensitivity to any of the components of the contraceptive implant.
Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate

Characteristics that would preclude involvement after delivery:

Birth of a stillborn infant.
Maternal ICU admission after delivery
Maternal postpartum hemorrhage requiring blood transfusion
Prolonged hospital stay (>7 days) postpartum
Coagulopathy associated with the pregnancy
Severe pregnancy-induced hypertension
Fever >38 degrees C postpartum
Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 4
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 96
Group description: randomized to receive contraceptive implant prior to leaving the hospital postpartum

Contraceptive implant
Eligibility criteria:
Inclusion Criteria:

Adolescents ages 14-24 attending prenatal care
Greater than 20 weeks estimated gestational age
English or Spanish-speaking
Desire to use the contraceptive implant for contraception postpartum
Anticipated delivery of a healthy infant vaginally or by cesarean.

Exclusion Criteria:

Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including

current or past history of thrombosis or thromboembolic disorders
hepatic tumors (benign or malignant)
active liver disease
undiagnosed abnormal genital bleeding
known or suspected carcinoma of the breast (or a personal history of breast cancer)
hypersensitivity to any of the components of the contraceptive implant.
Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate

Characteristics that would preclude involvement after delivery:

Birth of a stillborn infant.
Maternal ICU admission after delivery
Maternal postpartum hemorrhage requiring blood transfusion
Prolonged hospital stay (>7 days) postpartum
Coagulopathy associated with the pregnancy
Severe pregnancy-induced hypertension
Fever >38 degrees C postpartum
Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial
Intervention: Tacrolimus
Trial phase: Phase 2
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)

Prograf: Tacrolimus
Eligibility criteria:
Inclusion criteria

Give written consent
Male and female subjects between the ages of 18 and 70 years, inclusive
Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
WOCBP must have a negative pregnancy test
Must have negative cross-match test and be ABO-compatible
Must be able to swallow tablets and capsules

Exclusion criteria

Recipients of any previous nonrenal or concurrent transplant
Have panel reactive antibody >50%
Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
History of alcohol abuse with less than 6 months of sobriety
History of recreational drug abuse with less than 6 months of documented abstinence
Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
Oral temperature (prior to study drug dosing) of 38.0ºC or higher
CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
Known hereditary immunodeficiency
Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Clinically symptomatic CHF or documented EJF of less than 45%
Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
Laboratory variables that are abnormal (outside laboratory reference range) and CS
Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
Subjects who have had primary focal segmental glomerulosclerosis
Donor parameters must not include any of the following known conditions:

Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
Intervention: 99mTc-MIP-1404
Trial phase: Phase 2
SMILES: O=C(O)CCC(NC(=O)NC(CCC(=O)NC(CCCCN(Cc1nccn1CC(=O)N(CC(=O)O)CC(=O)O)Cc1nccn1CC(=O)N(CC(=O)O)CC(=O)O)C(=O)O)C(=O)O)C(=O)O.[CH-]=O.[CH-]=O.[CH-]=O.[Cl-].[Tc+4]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Eligibility criteria:
Inclusion Criteria:

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Biopsy confirmed presence of adenocarcinoma of the prostate gland.
At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130.
Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.

Exclusion Criteria:

Participating would significantly delay the scheduled standard of care therapy.
Administered a radioisotope within 5 physical half lives prior to study drug injection.
Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Have a contraindication for MR imaging.
Intervention: Erlotinib
Trial phase: Phase 3
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
Measurable disease according to RECIST
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy greater than or equal to (>/=) 12 weeks
Adequate hematological, liver and renal function
Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria:

Previous chemotherapy or treatment against EGFR for metastatic disease
Treatment with an investigational agent less than 3 weeks before enrollment
History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
Participants with symptomatic cerebral metastases
Any significant ophthalmologic abnormality
Unstable systemic disease
Coumarins use
Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Intervention: NORETHINDRONE ACETATE
Trial phase: Not Applicable
SMILES: C#C[C@]1(OC(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: o PI therapy, control group

Norethindrone acetate
Eligibility criteria:
Inclusion Criteria:

Ages: 18-44 years Gender: female Accepts: healthy volunteers and HIV-1 infected women Acceptable medications include: no other medications, NRTI combinations, entry inhibitors, integrase inhibitors, and CCR5 agonists. NRTI combinations may include but are not limited to: zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF). NNRTI: etravirine, and rilpivirine.

Exclusion criteria:

History of bilateral oophorectomy, ovarian dysfunction or no regular periods. CD4+ cell count <200 cells/mm3 No current or uncontrolled thyroid, liver, or renal disease BMI <40 kg/m^2 Current pregnancy, breastfeeding or pregnancy within 30 days of enrollment. Depomedroxyprogesterone acetate injection (DMPA) within 180 days prior to study entry.

Other hormonal therapies (e.g. oral contraceptive agents, Provera, vaginal ring, contraceptive patch, monthly contraceptive injection, hormone replacement therapy, anabolic therapies, including nandrolone decanoate or megestrol acetate) within the 21 days prior to study entry.
Intervention: GABAPENTIN ENACARBIL
Trial phase: Phase 4
SMILES: CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Once-daily dose with food in the evening at approximately 5 PM
Eligibility criteria:
Inclusion Criteria:

Men or women 18 years of age or older
History of RLS symptoms for at least 15 nights/month
Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study
Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
Body mass index of 34 or below
Estimated creatinine clearance of ≥60 mL/min
Provides written consent in accordance with all applicable regulatory requirements

Exclusion Criteria:

History of a sleep disorder that may affect the assessment of RLS
History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
Neurologic disease or movement disorder
Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
Have clinically significant or unstable medical conditions
Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt
Intervention: GABAPENTIN ENACARBIL
Trial phase: Phase 4
SMILES: CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Once-daily dose with food in the evening at approximately 5 PM
Eligibility criteria:
Inclusion Criteria:

Men or women 18 years of age or older
History of RLS symptoms for at least 15 nights/month
Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study
Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
Body mass index of 34 or below
Estimated creatinine clearance of ≥60 mL/min
Provides written consent in accordance with all applicable regulatory requirements

Exclusion Criteria:

History of a sleep disorder that may affect the assessment of RLS
History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
Neurologic disease or movement disorder
Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
Have clinically significant or unstable medical conditions
Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt
Intervention: GABAPENTIN ENACARBIL
Trial phase: Phase 4
SMILES: CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Once-daily dose with food in the evening at approximately 5 PM
Eligibility criteria:
Inclusion Criteria:

Men or women 18 years of age or older
History of RLS symptoms for at least 15 nights/month
Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study
Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
Body mass index of 34 or below
Estimated creatinine clearance of ≥60 mL/min
Provides written consent in accordance with all applicable regulatory requirements

Exclusion Criteria:

History of a sleep disorder that may affect the assessment of RLS
History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
Neurologic disease or movement disorder
Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
Have clinically significant or unstable medical conditions
Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt
Intervention: Resveratrol
Trial phase: Not Applicable
SMILES: Oc1ccc(/C=C/c2cc(O)cc(O)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: 12 men will receive a pill with 500mg of resveratrol
Eligibility criteria:
Inclusion Criteria:

clinical history, physical examination and electrocardiogram normal

Exclusion Criteria:

premenopausal women (less than 1 year of natural amenorrhea)
Body mass index ≥ 35 kg/m2
Smoking
Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
Diabetes
Previous using previous statins or hormone replacement therapy. Other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.
Intervention: Resveratrol
Trial phase: Not Applicable
SMILES: Oc1ccc(/C=C/c2cc(O)cc(O)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: 12 women will receive a pill with 500mg of resveratrol
Eligibility criteria:
Inclusion Criteria:

clinical history, physical examination and electrocardiogram normal

Exclusion Criteria:

premenopausal women (less than 1 year of natural amenorrhea)
Body mass index ≥ 35 kg/m2
Smoking
Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
Diabetes
Previous using previous statins or hormone replacement therapy. Other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.
Intervention: Letrozole
Trial phase: Not Applicable
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Adverse events collected during part A, 29 days of monitored adherence to standard of care letrozole and Part B .
Eligibility criteria:
Inclusion Criteria:

Postmenopausal female patients
histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy
Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months
Willing to provide written informed consent to participate
for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2

Exclusion Criteria:

Known abnormal liver or renal function defined by:

Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance < 40 mL/min
Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times ULN
Presence of persistent local or known metastatic cancer