anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Azacitidine
Trial phase: Phase 2
ATC code: L01BC07
SMILES: Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: 75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of MF requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hemoglobin (Hb) < 10 g/dl, White Blood Cell (WBC) < 4 or > 30 x 10*9/L; risk group: 0 = low, 1 = intermediate, 2 = high).
Performance 0-2 Eastern Cooperative Oncology Group (ECOG).
Signed informed consent.
Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxic effects (grade 0-1) of that therapy. Patients are allowed to be on anagrelide and hydroxyurea to control high platelet and WBC counts for their safety.
Serum bilirubin levels </= 1.5 times the upper limit of the normal range for the laboratory Upper Limit of of Normal(ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels </= 2 x ULN.
Serum creatinine levels </= 1.5 x ULN; unless related to the MF, as judged by treating physicians.
Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment and should be advised to avoid becoming pregnant. Men must be advised to not father a child while receiving treatment with azacitidine. Both women of childbearing potential and men must practice effective methods of contraception (those generally accepted as standard of care measures).
Age >/= 18.

Exclusion Criteria:

Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Known or suspected hypersensitivity to azacitidine or mannitol.
Intervention: Phenoxybenzamine
Trial phase: Phase 2
ATC code: C04AX02
SMILES: CC(COc1ccccc1)N(CCCl)Cc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 785
Group description: Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
Eligibility criteria:
Inclusion Criteria:

0-18 years of age
weight of less than or equal to 20 kilograms

Exclusion Criteria:

Parental refusal to give informed consent
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: All patients will be prescribed Tarceva 150mg daily

Erlotinib: 150 mg per day by mouth for 12 months
Eligibility criteria:
Inclusion Criteria:

Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
Prior radiation therapy for head and neck cancer
Disease must be considered surgically resectable or candidate for curative reirradiation
Adequate diagnostic workup
Zubrod Performance Status 0-2
Life expectancy 12 weeks
Age 19, 9. Adequate laboratory data.

Exclusion Criteria:

Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
Patients who are pregnant or lactating
Psychological condition that renders the patient unable to understand the informed consent
Any situation or condition that will interfere with adherence to study activities.
Intervention: Nitrogen
Trial phase: Phase 1 | Phase 2
ATC code: V03AN04
SMILES: N#N
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CF
12 years of age and older
FEV1 greater than 40% of predicted
Resting awake oxygen saturation of at least 88%
Stable pulmonary disease as defined by both clinical impression and having had no recent hospitalizations or changes in antibiotic regimen within 1 month prior to enrollment
Signed informed consent form

Exclusion Criteria:

Pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within 1 month of enrollment
Isolation of B. cepacia from a respiratory tract culture within 6 months
Severe nasal obstruction at the time of screening
Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
Pregnancy (a negative pregnancy test must be documented prior to enrollment if applicable)
Patients who have received treatment with nitric oxide for inhalation within 24 hours prior to study initiation or other investigational medications within 24 hours.
Intervention: OBETICHOLIC ACID
Trial phase: Phase 2
ATC code: A05AA04
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCC(=O)O)[C@@]1(C)CC[C@]1([H])[C@@]3(C)CC[C@@H](O)C[C@@]3([H])[C@@H](CC)[C@@H](O)[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: OCA 50 mg for 3 months during the DB phase.
Eligibility criteria:
Inclusion Criteria:

Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing.
Male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy.
Proven or likely PBC, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors:
History of increased alkaline phosphatase (ALP) levels for at least 6 months;
Positive antimitochondrial antibody titer (>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive);
Liver biopsy consistent with PBC
Screening ALP level between 1.5 and 10 × upper limit of normal (ULN).

Exclusion Criteria:

Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids.
Screening conjugated (direct) bilirubin >2 × ULN.
Screening alanine aminotransferase or aspartate aminotransferase >5 × ULN.
Screening serum creatinine >133 micromoles/liter (1.5 mg/deciliter).

History or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites).

History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis.
Pregnancy.
Intervention: Utibron Neohaler
Trial phase: Phase 2
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Eligibility criteria:
Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
Patients who have smoking history of at least 10 pack years.
Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with uncontrolled Type I and Type II diabetes.
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Indacaterol
Trial phase: Phase 2
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Eligibility criteria:
Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
Patients who have smoking history of at least 10 pack years.
Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with uncontrolled Type I and Type II diabetes.
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Indacaterol
Trial phase: Phase 2
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Eligibility criteria:
Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
Patients who have smoking history of at least 10 pack years.
Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with uncontrolled Type I and Type II diabetes.
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Risperdal Consta injection in conjunction with existing treatment

Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.
Eligibility criteria:
Inclusion Criteria:

Be physically healthy
18-60 years of age
Have a DSM-IV diagnosis of bipolar disorder in any phase, but without current psychotic features; with a history of symptomatic relapse on four or more occasions over the last year prior to the initiation of study for the treatment of bipolar disorder (type I or II, manic, hypomanic, mixed, or depressive type), with at least 1 in the previous 6 months.
Have a screening Hamilton Rating Scale for Depression-17 item (HAM-D17) score of > 8 or a Young Mania Rating Scale (YMRS) > 8.

Exclusion Criteria:

Have any medical condition that would preclude treatment with Risperdal Consta(TM)
Have type 2 diabetes
Have hyperlipidemia (baseline total cholesterol >280)
Have any clinically significant unstable medical condition
Have currently active psychotic symptoms (hallucinations or delusions) or carry a diagnosis of another psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)
Have a documentable history of non-response to Risperidal Consta (TM)
Have a score of 4 on the suicide item (item 3) of the HAM-D scale and/or a determination by the investigator of significant suicide risk
Require hospitalization between the screening and baseline visits, or require hospitalization immediately following baseline
Have a medical contraindication or hypersensitivity to risperidone or Risperdal Consta (TM)
Intervention: Acamprosate
Trial phase: Phase 1 | Phase 2
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Acamprosate: 2 gr/day (333 mg, TID)
Eligibility criteria:
Inclusion Criteria:

Methamphetamine dependence
Treatment seeking
Urine sample (+) for methamphetamine

Exclusion Criteria:

Pregnancy
Dependence on other drugs (except nicotine)
DSM-IV axis I disorder unrelated to drug abuse
Serious medical condition in clinicians opinion.
AIDs
Untreated syphilis
Allergy to acamprosate
Methadone, or other ORP, maintenance
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Participants were randomized into the Simvastatin arm of this trial.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)
Radical prostatectomy chosen as primary treatment for prostate cancer
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)
Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
History of or active liver disease or abnormal results of the baseline liver function test (> 2 x normal)

Current use of:

simvastatin
lovastatin
other HMG-CoA inhibitors
lipid-lowering agents
Amiodarone
Cholestyramine
Cholestyramine and colestipol (bile acid sequestrants)
Clofibrate and fenofibrate
Cyclosporine
CYP3A4 inhibitors
Danazol
Diltiazem
Gemfibrozil
Niacin ( 1 g/day)
Verapamil and Warfarin
Known allergy or sensitivity to ingredients in simvastatin
Intervention: 3-Nitropropionic acid
Trial phase: Phase 2
SMILES: O=C(O)CC[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Eligibility criteria:
Inclusion criteria:

Patients with acute ST elevation myocardial infarction with > or = 2 mm ST elevation in one or any combination of anterior leads, with successful revascularization (TIMI grade 3 flow) of the lesion within 24 hours of symptoms and consented within 24 hours of procedure.

Exclusion criteria:

Cardiogenic shock or hypotension, Systolic BP< 90 mmHg or overt Congestive Heart Failure (CHF)
Previous history of MI (Myocardial Infarction)
Previous ECG suggesting previous MI
Known Ejection Fraction (EF) < 30%
Atrial fibrillation
Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease.
Hemoglobin <10 mg/dL
Pregnant women/nursing mothers
Participants still menstruating and have not been surgically sterilized must have a negative pregnancy test prior to participating in this study.
Unable to undergo cardiac MRI (Magnetic Resonance Imaging).
Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.