anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Methylphenidate
Trial phase: Phase 3
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 145
Group description: Methylphenidate Transdermal System Patch
Eligibility criteria:
Inclusion Criteria:

Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
Subject is a male or female aged 13 17 years.
Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.

Exclusion Criteria:

Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
Subject is overweight.
Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
Subject has Conduct Disorder.
Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
Subject has a history of alcohol or other substance abuse or dependence.
Subject has taken an investigational drug within 30 days prior to screening.
Subject has any abnormal thyroid function.
Subject has any clinically significant laboratory abnormalities.
Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary.
The female subject is pregnant or lactating.
Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis).
Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.
Intervention: EXENATIDE
Trial phase: Phase 2
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
Eligibility criteria:
Inclusion Criteria:

Have a Body Mass Index (BMI) >= 30kg/m^2

Exclusion Criteria:

Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
Are actively participating in, or have participated in a formal weight loss program within the last 3 months
Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
Have been treated with any anti-diabetic medications within 3 months of screening
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
Have had bariatric surgery
Have had an organ transplant
Intervention: ASPIRIN
Trial phase: Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 325 mg by mouth Day 1, 160 mg daily thereafter
Eligibility criteria:
Inclusion Criteria:

Presenting for Cardiology consult at M.D. Anderson Cancer Center.
Platelet count between 100,000 and 20,000.
Acute Coronary Syndrome diagnosed with their first 12 lead EKG.
Patients that continue to show evidence of MI by cardiac enzymes with CPK levels > 2 normal limits, CK-MB levels 10% above normal limits, and Troponin I levels > 1.4ug/L will be considered positive for MI.
Ability to give consent.

Exclusion Criteria:

Contraindications to aspirin including severe intolerance or true allergy, active bleeding, hemophilia, active retinal bleeding, severe untreated hypertension, active peptic ulcer, or other significant source of gastrointestinal or genitourinary bleeding, brain metastasis, and altered mental status.
Unwillingness or inability to give consent.
Progressive heart failure, unstable angina not responding to medical therapy for 24 hours, or ventricular tachycardia, necessitating thrombolysis, and angioplasty.
Patients that rule out for MI by cardiac enzymes panel after the first 24 hours.
Patients that rule in for MI and have Platelet count > 100,000.
Patients with platelet count < 20,000.
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: 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: 55
Group description: 12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
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 COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.

Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count > 400/mm3
Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: 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: 51
Group description: 25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
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 COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.

Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count > 400/mm3
Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: 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: 53
Group description: 50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
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 COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.

Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count > 400/mm3
Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: 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: 54
Group description: 100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
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 COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.

Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count > 400/mm3
Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Tiotropium
Trial phase: Phase 2
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: 54
Group description: 18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
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 COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.

Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count > 400/mm3
Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 8 mg pill taken by mouth nightly
Eligibility criteria:
Inclusion Criteria:

Male or female age 18-65 yrs.
A diagnosis of seasonal affective disorder
A Pittsburgh Sleep Quality Index >5
English speaking
Be able to sign informed consent

Exclusion Criteria:

Active substance abuse
Current psychotic symptoms
Severe personality disorders
Primary sleep disorders
Severe chronic obstructive pulmonary disease (COPD)
Prescription fluvoxamine(Luvox) use
Intervention: Doripenem
Trial phase: Phase 2
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 183
Group description: 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
Eligibility criteria:
Inclusion Criteria:

Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
All patients must be hospitalized throughout the treatment period
Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy

Exclusion Criteria:

Known or suspected severe kidney impairment
Known or suspected liver dysfunction
Treatment with any investigational drug or device within 30 days before enrollment
Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
Women who are pregnant or lactating