anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acamprosate
Trial phase: Phase 2
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Acamprosate

Acamprosate: Total dose, 1998 mg daily, 1 week duration
Eligibility criteria:
Inclusion Criteria:

Males or females ≥ 18 and ≤ 55 years of age
Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
Does not desire treatment
Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
Able to complete and understand questionnaires and study procedures in English
Verbal I.Q. estimate ≥ 85
Signed informed consent

Exclusion Criteria:

Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
Significant medical disorders that will increase potential risk or interfere with study participation
Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
Liver function tests more than three times normal or elevated bilirubin
No fixed domicile and/or no availability by telephone or beeper
Current involvement in or plans for treatment prior to study completion
Patients who have a history of adverse drug reactions to the study drugs or their ingredients
Failure to take double-blind medication as prescribed
Inability to understand or comply with the provisions of the protocol or consent form
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
Healthy volunteers: No
Participants at risk: 25
Group description: Naltrexone

Naltrexone: 50mg capsule, Once daily, 1 week duration
Eligibility criteria:
Inclusion Criteria:

Males or females ≥ 18 and ≤ 55 years of age
Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
Does not desire treatment
Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
Able to complete and understand questionnaires and study procedures in English
Verbal I.Q. estimate ≥ 85
Signed informed consent

Exclusion Criteria:

Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
Significant medical disorders that will increase potential risk or interfere with study participation
Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
Liver function tests more than three times normal or elevated bilirubin
No fixed domicile and/or no availability by telephone or beeper
Current involvement in or plans for treatment prior to study completion
Patients who have a history of adverse drug reactions to the study drugs or their ingredients
Failure to take double-blind medication as prescribed
Inability to understand or comply with the provisions of the protocol or consent form
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 2
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 440 micrograms twice daily by oral inhalation.
Eligibility criteria:
Inclusion Criteria:

Patients >/=18 years of age.
Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation.
New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%.
Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.
Patient must be willing to comply with all study procedures and capable of signing informed consent.

Exclusion Criteria:

Patients with active pulmonary infection.
Patients with known hypersensitivity to corticosteroids
Intervention: Sitagliptin
Trial phase: Early Phase 1
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: There is only one group. All the participants took the Sitagliptin.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
Age > 18 yrs

Exclusion Criteria:

Cardiomyopathy primarily due to one of the following:

Ischemic heart disease
Primary valvular lesion
Hypertrophic cardiomyopathy
Cardiac resynchronization within the last 3 months
Calculated creatinine clearance <30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.

Diagnosis of diabetes mellitus by:

Diabetes previously diagnosed per patient history
2 or more fasting glucose values > 125 mg/dl
History of heart transplantation
Pregnancy or active breast feeding
Hospitalization for decompensated heart failure within 30 days prior to enrollment.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Healthy Volunteers receiving Lidocaine
Eligibility criteria:
Inclusion Criteria:

Healthy Adult Volunteers, age >19 years

Exclusion Criteria:

History of Substance Abuse
Coronary Artery Disease (CAD): unstable
Congestive Heart Failure (CHF): unstable
Heart Arrhythmia: symptomatic
Chronic Obstructive Pulmonary Disease (COPD)
Lidocaine Allergy
Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
Presence of Contraindications for MRI
Presence of electronically, magnetically, and mechanically activated implants
Electronically, magnetically, and mechanically activated implants
Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
Cardiac pacemakers
Metallic splinters in the eye
Ferromagnetic haemostatic clips in the central nervous system (CNS)
Claustrophobia
Pregnancy
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 4
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Eligibility criteria:
Inclusion Criteria:

Any male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist will be eligible for participation.
Verbal consent of participation must be given by parent or guardian and child.

Exclusion Criteria:

Age less than 13 or greater than 18 years of age.
Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
Inability to complete all study-related visits.
Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
Subjects should not be using topical retinoids or benzoyl peroxide products, including Proactive® or topical prescription medications for the treatment of acne vulgaris for at least 2 weeks prior to beginning the study. Oral medications for the treatment of acne should not have been used at least 4 weeks prior to beginning the study.
Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
Intervention: Zolpidem Tartrate
Trial phase: Phase 1
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 | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
Eligibility criteria:
Inclusion Criteria:

Sex: Male or Female; similar proportions of each preferred
Age: At least 18 years
Weight: must be 15% of ideal weight for height and frame
Subjects must be in good health and physical condition as determined by medical history
Subjects must read and sign the Consent Form

Exclusion Criteria:

history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months
history of malignancy, stroke, diabetes, cardiac, renal or liver disease
history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease
history of treatment for asthma within the past five (5) years
history of mental depression, pulmonary disease, sleep apnea
females who are pregnant or lactating
history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative
conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position
inability to read and/or sign the consent form
treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study
subjects who have donated blood within four (4) weeks prior to the initial dosing for this study
subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.
Intervention: Pimavanserin Tartrate
Trial phase: Phase 3
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Placebo tablet, once daily by mouth, 6 weeks
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
The subject is willing and able to provide consent
Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
Subject has had a myocardial infarction in last six months
Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Intervention: Pimavanserin Tartrate
Trial phase: Phase 3
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
The subject is willing and able to provide consent
Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
Subject has had a myocardial infarction in last six months
Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Intervention: Pimavanserin Tartrate
Trial phase: Phase 3
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
The subject is willing and able to provide consent
Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
Subject has had a myocardial infarction in last six months
Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Intervention: Basaglar
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Eligibility criteria:
Inclusion Criteria:

Type 1 diabetes
Treated with long-acting and meal time insulin therapy for at least 2 years
Ages 18 to 60 years of age
Glycosylated hemoglobin value between 7 - 9 mg/dL
C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.

Exclusion Criteria:

Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
Pregnancy
Alcohol or drug abuse or dependence within three months of study entry
Less than 50 % agreement on 50-item Food Questionnaire with the Food Array "buffet style" study meal.
Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.
Intervention: Tamoxifen
Trial phase: Phase 3
ATC code: L02BA01
SMILES: CC/C(=C(\c1ccccc1)c1ccc(OCCN(C)C)cc1)c1ccccc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Tamoxifen 20mg orally daily for 5 years
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Completely resected disease

Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy

Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:

Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist
Ovarian irradiation
Bilateral oophorectomy

Hormone receptor status:

Estrogen and/or progesterone receptor positive

Each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Premenopausal
Can speak and read the local language(s) fluently

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Intervention: AZD-1940
Trial phase: Phase 2
SMILES: CCS(=O)(=O)Nc1ccc2c(c1)nc(C(C)(C)C)n2CC1CCC(F)(F)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 61
Group description: AZD1940 800ug given predose
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
Provision of signed informed consent.
Healthy males or non-fertile females.

Exclusion Criteria:

History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
Intervention: Naproxen
Trial phase: Phase 2
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Naproxen 500mg given pre-surgery
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
Provision of signed informed consent.
Healthy males or non-fertile females.

Exclusion Criteria:

History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.