anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Vismodegib
Trial phase: Phase 2
ATC code: L01XJ01 | L01XX43
SMILES: CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants received vismodegib 150 mg orally daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.
Intervention: Vismodegib
Trial phase: Phase 2
ATC code: L01XJ01 | L01XX43
SMILES: CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
Eligibility criteria:
Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
Eligibility criteria:
Inclusion Criteria:

Males and females > 18 years of age
Life expectancy of at least 2 months
Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
ECOG Performance Status of 0-2

Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:

ANC ≥ 1.5 x 109/L
Platelet Count ≥ 100 x 109/L
Hemoglobin ≥ 9g/dL
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN
ALK-P ≤ 3 x ULN
Serum creatinine ≤ 1.8mg/dL
Calculated Serum Creatinine Clearance 40 - > 60ml/min
Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
Willing and able to provide written informed consent.

Exclusion Criteria:

Known central nervous system (CNS) tumor involvement
Evidence of other active malignancy requiring treatment
Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
Known infection with HIV or hepatitis
Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
Active, serious systemic disease, including active bacterial or fungal infection.
Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
Intervention: Losmapimod
Trial phase: Phase 2
SMILES: Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
Eligibility criteria:
Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years
Intervention: Losmapimod
Trial phase: Phase 2
SMILES: Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
Eligibility criteria:
Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years
Intervention: Losmapimod
Trial phase: Phase 2
SMILES: Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.
Eligibility criteria:
Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years
Intervention: Chlordiazepoxide
Trial phase: Phase 2 | Phase 3
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: multivitamin solution without iron
Eligibility criteria:
Inclusion Criteria:

birth weight: < 1500 grams
Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

cyanotic heart disease
bowel resection prior to enrollment
Intervention: Minoxidil
Trial phase: Phase 3
ATC code: C02DC01 | D11AX01
SMILES: Nc1cc(N2CCCCC2)nc(N)[n+]1[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 203
Group description: 5% Minoxidil Topical Foam

5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
Eligibility criteria:
Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the (study product), or any ingredients of the (study product)
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Levetiracetam: Oral dose tablets, twice daily
Eligibility criteria:
Inclusion Criteria:

An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria:

Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: 250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
Subjects suffering from special syndromes (classification IV according to the ILAE classification)
History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
Presence of exclusively type IA non-motor seizures.
History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
History or presence of known pseudo-seizures
Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
Intervention: INSULIN DETEMIR
Trial phase: Not Applicable
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.

insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetic
18-50 years
BMI > 25kg/m2
HbA1c 7.0-10.0%
Treated with up to 2 oral agents

Exclusion Criteria:

Chronic illness or infection (other than diabetes mellitus)
Known coronary artery disease, structural heart disease or abnormal ECG on screen.
Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
Current pregnancy
Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
Known intolerance to GLP-1 agonist
Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
Recognized microvascular complications (neuropathy, nephropathy, retinopathy).