anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oxeze
Trial phase: Phase 4
SMILES: COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O.O.O=C(O)C=CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 60
Group description: Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Eligibility criteria:
Inclusion Criteria:

Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Exclusion Criteria:

Patients with severe acute bronchial obstruction determined by functional and clinical evidence
Patients unable to use the inhaling device at time of treatment
Patients who received a bronchodilator drug within the last 12 hours
Patients who received inhaled steroids within the last 72 hours
Patients who received systemic steroids within the last 7 days
Patients with near fatal asthma history
Patients with fever (>38.5°C axillar temp)
Patients with any clinical significance condition

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Fenoterol-ipratropium
Trial phase: Phase 4
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2.CC(Cc1ccc(O)cc1)NCC(O)c1cc(O)cc(O)c1.[Br-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 60
Group description: Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Eligibility criteria:
Inclusion Criteria:

Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Exclusion Criteria:

Patients with severe acute bronchial obstruction determined by functional and clinical evidence
Patients unable to use the inhaling device at time of treatment
Patients who received a bronchodilator drug within the last 12 hours
Patients who received inhaled steroids within the last 72 hours
Patients who received systemic steroids within the last 7 days
Patients with near fatal asthma history
Patients with fever (>38.5°C axillar temp)
Patients with any clinical significance condition

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Active drug given in phase 1, then placebo pill given in phase 2.
Eligibility criteria:
Inclusion Criteria:

Nursing Home Patients
Age 65 and above

Exclusion Criteria:

Under age 65
Anticipated short stay (short term or hospice)
Severe behavioral disturbance
Unstable drug regimen in prior 2 weeks

Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

once per week in prior 2 weeks
Use of a potent inhibitor of CYP3A4
Parkinson's with uncontrolled tremor
Severe Dementia
Severe Sleep Apnea
Inability to tolerate wrist Actigraphy
Sleep Efficiency >75%
Sleep apnea
Sleep efficiency of greater than 75% during the night.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
Eligibility criteria:
Inclusion Criteria:

Nursing Home Patients
Age 65 and above

Exclusion Criteria:

Under age 65
Anticipated short stay (short term or hospice)
Severe behavioral disturbance
Unstable drug regimen in prior 2 weeks

Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

once per week in prior 2 weeks
Use of a potent inhibitor of CYP3A4
Parkinson's with uncontrolled tremor
Severe Dementia
Severe Sleep Apnea
Inability to tolerate wrist Actigraphy
Sleep Efficiency >75%
Sleep apnea
Sleep efficiency of greater than 75% during the night.
Intervention: Montelukast
Trial phase: Phase 3
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 566
Group description: Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent
Intervention: Vardenafil
Trial phase: Phase 2
ATC code: G04BE09
SMILES: CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
Eligibility criteria:
Inclusion Criteria:

Men with benign prostate hypertrophy requiring surgical treatment
Age up to 80 years
Documented, dated, written Informed Consent
Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery

Exclusion Criteria:

Any unstable medical, psychiatric, or substance abuse disorder
History of previous prostatectomy
Patients suspect of prostate cancer
Hereditary degenerative retinal disorder
History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment
Any cardiovascular condition
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Uncontrolled atrial fibrillation/flutter at screening
Severe chronic or acute liver disease
Chronic hematological disease which may lead to priapism
Bleeding disorder
Significant active peptic ulceration
Resting hypotension
History of positive test for Hepatitis B surface antigen or Hepatitis C
Symptomatic postural hypotension within 6 months of Visit 1
Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well
Subjects who are taking nitrates or nitric oxide donors
Subjects who are taking androgens or anti-androgens
Subjects who are taking potent inhibitors of cytochrome P4503A4
Subjects who have received any investigational drug within 30 days of Visit 1
Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
Use of inhibitors of 5-alpha reductase after ablation of prostate
Subjects with serum creatinine clearance <30.0 mL/min
Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >3 times the upper limit of normal
Subjects with known hypersensitivity to Vardenafil
Subjects who are illiterate or unable to understand subject diaries
Subjects who would be non-compliant with the study visit schedule
Intervention: Leptin
Trial phase: Phase 2
SMILES: CSCCC(N=C(O)C(CC(=O)O)N=C(O)C(CCC(=N)O)N=C(O)C(CC(C)C)N=C(O)C(CO)N=C(O)CN=C(O)C(CCC(=N)O)N=C(O)C(N)CC(C)C)C(O)=NC(CC(C)C)C(O)=NC(Cc1c[nH]c2ccccc12)C(O)=NC(CCC(=N)O)C(O)=NC(CC(C)C)C(O)=NC(CC(=O)O)C(O)=NC(CC(C)C)C(O)=NC(CO)C(=O)N1CCCC1C(O)=NCC(O)=NC(CS)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Randomized to receive leptin.
Eligibility criteria:
Inclusion Criteria - General inclusion:

Age > 14 years
HIV infection being treated with HIV-1 protease inhibitors for >6 months currently, or previous protease inhibitor therapy of at least 2 years duration with development of lipodystrophy and current stable therapy preferably for past 4 months.
Fasting serum triglycerides > 200 mg/dL

Exclusion Criteria - General exclusion:

Acute, ongoing AIDS-defining opportunistic infections.
Blood CD4 positive lymphocyte count < 200/mm3
Known liver disease due to causes other than nonalcoholic steatohepatitis with elevation of liver transaminases by more than two and a half times above the upper limits of normal (SGOT>105 U/L, SGPT>120 U/L) or total bilirubin (>1.5 mg/dL).
Hematocrit of less than 30%.
Current alcohol abuse (>7 drinks or 210 g per wk for women and >14 drinks or 420 g per wk for men).
Current substance abuse.
Uncontrolled diabetes mellitus with fasting plasma glucose > 180 mg/dL or hemoglobin A1c > 9%.
History of weight loss during the last 3 months.
Use of anorexiogenic drugs, thiazolidinediones, anabolic steroids and human growth hormone.
Major Neuro-psychiatric illnesses impeding competence or compliance.
Pregnant and lactating women.
Cancer excluding skin cancer other than melanoma.
Acute medical illnesses precluding participation in the studies.
Chronic renal insufficiency with serum creatinine > 2 mg/dL.
Untreated thyroid disorders such as hypothyroidism and hyperthyroidism. Each of the 4 treatment arms has additional specific inclusion and exclusion criteria
Intervention: Apaziquone
Trial phase: Phase 3
SMILES: Cn1c(/C=C/CO)c(CO)c2c1C(=O)C=C(N1CC1)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 406
Group description: Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Eligibility criteria:
Inclusion Criteria: (All questions must be answered YES)

Has the patient given written informed consent?
Is the patient at least 18 years old?
Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
Is the patient willing and able to abide by the protocol?

Exclusion Criteria: (All questions must be answered NO)

Does the patient have more than 4 bladder tumors?
Does any single bladder tumor exceed 3.5 cm in diameter?
Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
Has the patient ever received Apaziquone?
Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
Does the patient have an active urinary tract infection?
Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L?
Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
Does the patient have a known immunodeficiency disorder?
Has the patient received any investigational treatment within the past 30 days?
Is the patient breast feeding?
Does the patient have a history of interstitial cystitis?
Does the patient have a history of allergy to red color food dye?
Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
Intervention: Sulfadiazine
Trial phase: Phase 2
ATC code: G01AE10 | J01EC02 | J01EE02 | J01EE06
SMILES: Nc1ccc(S(=O)(=O)Nc2ncccn2)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours

BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
Eligibility criteria:
Inclusion Criteria:

Ages 13 years to 60 years old
Sustained partial-thickness or full-thickness burn greater than 20% and less than 41% TBSA
Parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent.
Able to start BPI in infusion within 8 hours of burn injury.

Exclusion Criteria:

Age > 61.
Inhalational injury requiring mechanical ventilation.
Partial and full thickness burns totaling > 41% total body surface area

Cardiac dysfunction, defined as the presence of any of the following:

New York Heart Class 3 or 4 heart failure.
Unstable angina or acute myocardial infarction.
Left ventricular ejection fraction known to be < 35%.
Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
Concomitant non-burn trauma with an ISS > 9.
Non-survivable injury secondary to burn size - patients made DNR or comfort care due to burn size.

Patients with known causes of immunosuppression:

Known history of HIV/AIDS
Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).
Active oncolytic therapy for known malignancy
Known or suspected pregnancy
Known allergy to rBPI21
Intervention: Acamprosate
Trial phase: Phase 3
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
Eligibility criteria:
Inclusion Criteria

Men and women between 21 and 65 years of age.
Patients with a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder NOS as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) [22].
Patients who are on stable treatment with psychotropic medication > 2 weeks prior to randomization.
Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 21 days, and willing to undergo detoxification or self discontinuation (for at least 5 days).
Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
Patients who have capacity to provide informed consent prior to entering any study procedure.

Exclusion Criteria

Patients with dementia, amnestic and other cognitive disorders.
Patients who have unstable medical disease or a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
Patients with a history of opioid dependence within the past month.
Patients with a history of intolerance or hypersensitivity to acamprosate.
Patients who are currently taking disulfiram or naltrexone.
Patients who based on history or mental status examination are at a significant risk for suicide.
Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
Women who are pregnant or nursing, or women of childbearing potential who are sexually active and who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.
Intervention: Tiotropium
Trial phase: Phase 2 | Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 415
Group description: Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Eligibility criteria:
Inclusion Criteria:

Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

Smoking history of at least 20 pack years
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value.
Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

Pregnant or lactating females
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long term oxygen therapy (> 15 h a day)
Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
Patients with a history of asthma (with further criteria)
Patients with Type I or uncontrolled Type II diabetes
Patients with contraindications for tiotropium
Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
Patients with a history of long QT syndrome or whose QTc interval is prolonged
Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
Patients who have had treatment with the investigational drug (with further criteria)
Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
Patients with known history of non compliance to medication
Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: FENOFIBRIC ACID
Trial phase: Phase 3
ATC code: C10AB05 | C10AB11
SMILES: CC(C)(Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 254
Group description: ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria

Adult male and female participants who voluntarily sign the informed consent.

Fasting lipid results following greater than 12-hour fasting period:

Triglycerides level greater than or equal to 150 mg/dL,
High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.
Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
Participants receiving coumarin anticoagulants or systemic cyclosporine.
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria

Adult male and female participants who voluntarily sign the informed consent.

Fasting lipid results following greater than 12-hour fasting period:

Triglycerides level greater than or equal to 150 mg/dL,
High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.
Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
Participants receiving coumarin anticoagulants or systemic cyclosporine.
Intervention: Zolpidem Tartrate
Trial phase: Phase 3
SMILES: Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1.Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 295
Group description: Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Eligibility criteria:
Inclusion Criteria:

Adults with history of sleeplessness

Exclusion Criteria:

Allergic to investigational drug
Any conditions and medications that may interfere with study drug evaluation
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Naltrexone 50mg-150mg by mouth per day.
Eligibility criteria:
Inclusion Criteria:

men and women age 21-75;
current diagnosis of compulsive sexual behavior

Exclusion Criteria:

unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
history of seizures;
myocardial infarction within 6 months;
current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
clinically significant suicidality;
current or recent (past 1 month) DSM-IV substance abuse or dependence;
illegal substance within 2 weeks of study initiation;
initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
initiation of a psychotropic medication within 2 months prior to study inclusion;
previous treatment with naltrexone; and
treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline