anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Clozapine
Trial phase: Not Applicable
ATC code: N05AH02
SMILES: CN1CCN(C2=Nc3cc(Cl)ccc3Nc3ccccc32)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Age 17 - 45
Meets Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder
Currently within the first episode of schizophrenia ("First Episode" is defined as having onset with the first evidence of psychotic symptoms by history, and the first episode will have ended if the Clinical Global Impressions Scale (CGI) has been < 2 and there has been no rating > 2 on any one of the Brief Psychiatric Rating Scale (BPRS) psychotic items for 6 weeks or longer)
Meets DSM-IV criteria for cannabis use disorder
Cannabis use within the five weeks prior to recruitment (screening visit or hospital admission) by self-report (TLFB), collateral report, or drug screen.
Requires treatment with an antipsychotic medication
Patients (or guardians) must provide informed consent prior to entry into the study

Exclusion Criteria:

Medical contraindications to treatment with clozapine or risperidone, including previous paralytic ileus.
Cumulative treatment with antipsychotic medication in excess of 16 weeks prior to hospital admission (or case identification if an outpatient), unless waived by the Medication Adjustment Group (MAG)
History of allergic reaction to clozapine or risperidone
History of seizure disorder or blood dyscrasia. Note: If patients have a history of seizures, but not a diagnosed seizure disorder, they may be admitted to the study if approved by the MAG.
Current treatment with clozapine
Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
Currently residing in a residential program designed to treat substance use disorders.
Treatment at baseline with a psychotropic agent proposed to curtail substance use (e.g. disulfiram, naltrexone, valproic acid, topiramate, acamprosate or benzodiazepines) will require a review by the medication adjustment group before entering the client into the study
Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study (For example, patients who are actively homicidal or have a pending incarceration that would prevent them from participating in the study)
History of, or current breast cancer
People who are doing well on current therapy
Lack of an identifiable primary family/support person, and unable to come to a study site for weekly visits
Treatment with serotonin re-uptake inhibitors will not be excluded but requires a review by the MAG prior to randomization.
Patients with current cocaine dependence will require review by the MAG to determine stability for the study.
Treatment with multiple antipsychotics or long acting injectable antipsychotic at baseline is not excluded, but will be reviewed by the MAG to assess appropriateness for the study.
Intervention: Risperidone
Trial phase: Not Applicable
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Age 17 - 45
Meets Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder
Currently within the first episode of schizophrenia ("First Episode" is defined as having onset with the first evidence of psychotic symptoms by history, and the first episode will have ended if the Clinical Global Impressions Scale (CGI) has been < 2 and there has been no rating > 2 on any one of the Brief Psychiatric Rating Scale (BPRS) psychotic items for 6 weeks or longer)
Meets DSM-IV criteria for cannabis use disorder
Cannabis use within the five weeks prior to recruitment (screening visit or hospital admission) by self-report (TLFB), collateral report, or drug screen.
Requires treatment with an antipsychotic medication
Patients (or guardians) must provide informed consent prior to entry into the study

Exclusion Criteria:

Medical contraindications to treatment with clozapine or risperidone, including previous paralytic ileus.
Cumulative treatment with antipsychotic medication in excess of 16 weeks prior to hospital admission (or case identification if an outpatient), unless waived by the Medication Adjustment Group (MAG)
History of allergic reaction to clozapine or risperidone
History of seizure disorder or blood dyscrasia. Note: If patients have a history of seizures, but not a diagnosed seizure disorder, they may be admitted to the study if approved by the MAG.
Current treatment with clozapine
Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
Currently residing in a residential program designed to treat substance use disorders.
Treatment at baseline with a psychotropic agent proposed to curtail substance use (e.g. disulfiram, naltrexone, valproic acid, topiramate, acamprosate or benzodiazepines) will require a review by the medication adjustment group before entering the client into the study
Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study (For example, patients who are actively homicidal or have a pending incarceration that would prevent them from participating in the study)
History of, or current breast cancer
People who are doing well on current therapy
Lack of an identifiable primary family/support person, and unable to come to a study site for weekly visits
Treatment with serotonin re-uptake inhibitors will not be excluded but requires a review by the MAG prior to randomization.
Patients with current cocaine dependence will require review by the MAG to determine stability for the study.
Treatment with multiple antipsychotics or long acting injectable antipsychotic at baseline is not excluded, but will be reviewed by the MAG to assess appropriateness for the study.
Intervention: Ademetionine
Trial phase: Phase 3
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
Eligibility criteria:
Inclusion Criteria

ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria with the presence of clinical and laboratory features of established liver disease. Also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study medication or placebo and required clinic visits and blood sampling.
a history of chronic alcoholism without evidence of liver disease;
healthy subjects without history of alcoholism or presence of liver disease.

Exclusion Criteria:

viral Hepatitis B or C
hemochromatosis
Wilson Disease
sclerosing cholangitis
primary biliary cirrhosis
other chronic disease
renal insufficiency
Intervention: Solifenacin Succinate
Trial phase: Phase 4
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 386
Group description: 5mg or 10mg tablet taken once daily
Eligibility criteria:
Inclusion Criteria:

Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
History of OAB symptoms for ≥ 3 months
An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria:

Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
History of diagnosed gastrointestinal obstruction disease
Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 4
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Intervention with Vyvanse
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV-TR criteria for ADHD
Has a Gender-Matched older sibling with ADHD and substance dependence
Medically healthy
Parents give informed consent
Child gives assent

Exclusion Criteria:

Significant use of alcohol or marijuana (more than ten episodes) in the past 30 days or any use of cocaine or opiates in the past 30 days; significant nicotine use is not an exclusion
History of cardiac abnormality, past cardiac problems or family history of the same, history of fainting, open-heart surgery, and arrhythmia
History of paranoia on stimulant medication
Seizure or other neurological disturbance
Pregnancy
Moderate to severe mental deficiency as determined by IQ <60 or placement in special education for mental deficiency
Physical exam or laboratory results with significant abnormalities
Active suicidal or homicidal ideation or history of suicide attempts
Unequivocal manic or hypomanic episode
Sexually active females who are unwilling to use effective methods of contraception
Psychosis or psychosis in a first degree relative
Current Major Depression
Individuals who have previously seen a cardiologist until reevaluated by a cardiologist
Individuals for whom the current cardiac evaluation is not definitive until seen by a cardiologist and given an echocardiogram
Individuals with Tic disorder
Significant co-morbid anxiety disorders (i.e., OCD, Panic, PTSD)
ADHD in remission on another psychostimulant or not in remission but in the context of inadequate dosing of a currently prescribed and administered other psychostimulant
Intervention: Morphine
Trial phase: Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Eligibility criteria:
Inclusion Criteria:

Must have a telephone
Age: patient must be 18 years or older and less than 70 years of age
Life expectancy of 3 months or greater
No prior use of step-3 opioids (step 2 opioids are allowed)
Provision of informed consent
Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
Moderate to severe cancer related pain that requires the use of step-3 opioids
Normal renal function
There will be no exclusionary criteria based on Karnofsky score
Must live no more than 1 hour away from clinic
Patient must have pain severity of 5-7/10 on a 0-10 pain scale

Exclusion Criteria:

Nursing home patients
Obvious cognitive dysfunction
Intractable nausea or vomiting
A true allergy or intolerance to opioids
Unstable renal function
Undergoing therapeutic procedures likely to influence pain during the study period
Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
History of drug seeking behavior
Respiratory compromise
Treatment with bisphosphonates within the last month
Use of MAO inhibitors
Drugs that interfere with CYP34A or CYP2D6
Drugs that interfere with morphine metabolism
Retroviral therapies
Active radiation or antineoplastic therapies
Hepatic dysfunction
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Study will exclude women who are pregnant and/or nursing
Women who are of child bearing potential must have a negative urine pregnancy test
Patients with a recent substance abuse history will be excluded
Patients with major depression will be excluded
Intervention: Enstilar
Trial phase: Phase 3
SMILES: C=C1C(=CC=C2CCCC3(C)C2CCC3C(C)C=CC(O)C2CC2)CC(O)CC1O.CCC(=O)OCC(=O)C1(OC(=O)CC)C(C)CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 366
Group description: adalimumab + calcipotriol/betamethasone ointment
Eligibility criteria:
Inclusion Criteria:

Subject is >= 18 years of age
Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

Subject has previous exposure to adalimumab
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Subject is taking or requires oral or injectible corticosteroids
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Subject has a calcium metabolism disorder
Intervention: Ramipril
Trial phase: Early Phase 1
ATC code: C09AA05 | C09BA05 | C09BB05 | C09BB07 | C09BX03 | C09BX05 | C10BX04 | C10BX06 | C10BX17 | C10BX18
SMILES: [H][C@@]12CCC[C@]1([H])N(C(=O)[C@H](C)N[C@@H](CCc1ccccc1)C(=O)OCC)[C@H](C(=O)O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Patients randomized to 6 months treatment of Ramipril.

Ramipril: Ramipril 20 mg once daily for 6 months
Eligibility criteria:
Inclusion:

48 (24 male / 24 female) with impaired glucose tolerance.
Impaired blood glucose values as outlined by the American Diabetes Association guideline. Fasting plasma glucose between 100 and 126 mg/dl or 2 hour post prandial glucose between 140 and 200 mg/dl
BMI > 25 kgM2
Age: 20-65 years
Treated or Untreated hypertension defined as measurement of seated BP at screening visit of systolic BP 120 to 150 and/ or diastolic BP 80 to 100.

Exclusion:

Patients receiving agents that can increase or lower blood glucose, i.e., metformin, thiazolidinediones, sulfonylureas, glitinides, acarbose, GLP-1 receptor agonists
Untreated or treated while seated Systolic Blood pressure >150and/or Diastolic Blood pressure >100
Taking hypertensive medications of HCTZ or ACE/ARB
Allergy to HCTZ, heparin, nitroglycerin or lidocaine
History of allergy or unacceptable side effects from ACE inhibitors
Pregnancy or intent to become pregnant during the study
Smoking
Subject unable to give voluntary informed consent

Physical Exam Exclusion Criteria

Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) from history or ECG in subjects > 40 years old
Pneumonia
Hepatic Failure/Jaundice
Renal Failure
Acute Cerebrovascular/ Neurological deficit
Fever greater than 38.0 C

Screening Laboratory Tests Exclusion Criteria according to protocol
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Eligibility criteria:
Inclusion Criteria:

Age 21 or greater, less than 90
Stable ischemic heart disease

Exclusion Criteria:

Recent myocardial infarction, coronary artery bypass graft surgery, or other revascularization procedures (less than 3 months ago)
Left ventricular ejection fraction(LVEF) < 15% measured by echocardiography, radionuclide ventriculography (RNV), or cardiac catheterization
Life threatening arrhythmia or arrhythmia interrupting the interpretation of ischemia
Unable to withdraw from anti-anginal medications during ischemic assessment phase
Unable to perform exercise testing
Pregnancy
Current or previous history of bipolar disorder, cyclothymia, schizophrenia, schizoaffective or schizophreniform disorder, or other psychotic disorders
Active suicidal ideation
Current substance abuse or history of substance abuse in the previous 6 months
Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study
Seizure (history and/or present) with/without treatment
Currently taking antidepressants that cannot be discontinued
Intervention: MEGESTROL ACETATE
Trial phase: Not Applicable
ATC code: G03AA04 | G03AB01 | G03AC05 | G03DB02 | G03FA08 | G03FB04 | L02AB01
SMILES: [H][C@@]12C=C(C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Elderly males and females
Age 65-80 years
With stable (no history of urgent/ emergent care visits with health care provider/s in the preceding 2 months), medical conditions

Exclusion Criteria:

Subjects will be excluded if they have a history of (H/O):

Dementia
Adrenal disease
Thromboembolism
Diabetes mellitus
Liver disease
Electrolyte abnormalities; or
Vaginal bleeding
Hypertriglyceridemia
CAD with CHF
Unstable depression
Schizophrenia; and
Morbidly obese subjects.
Intervention: Fenofibrate
Trial phase: Phase 2
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
Signed informed consent after careful review of the information and study details by one of the investigators

Exclusion Criteria

Hypersensitivity to fenofibrate
Prisoners and institutionalized subjects
Pregnant or nursing women
Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
Recipients of liver transplantation
Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
Acute or chronic renal failure
Known history of cholecystitis with intact gallbladder
Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity
Intervention: Tigecycline
Trial phase: Phase 3
ATC code: J01AA12 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(NC(=O)CNC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
Eligibility criteria:
Inclusion Criteria:

Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment.
Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate.
The presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of CAP within 24 hours before the first administration of test article.

Exclusion Criteria:

Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline.
Known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.