anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Truvada + NNRTI or PI.
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive polymerase chain reaction for HIV-1 ribonucleic acid (RNA).
Adult patients (over 18 years of age).
Current HAART regimen containing zidovudine + lamivudine at usual doses for at least 6 months.
Viral load < 50 copies/mL on the last two consecutive determinations, under zidovudine + lamivudine containing HAART regimen.
For women of childbearing potential, negative urine pregnancy test at screening visit.
Agreement to take part in the study and sign the informed consent.
Patients on lipid lowering treatment were allowed to participate in the study only if the lipid-lowering treatment (either statins or fibrates) was stable for at least 8 weeks prior to screening and it was not expected to change during the first 3 months of the study.

Exclusion Criteria:

Patients on current FTC or TDF therapy.
Patients with previous history of virological failure on an FTC or TDF-containing regimen.
Patients receiving a non-registered antiretroviral drug.
Patients receiving a triple-nucleoside antiretroviral combination.
Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of those drugs.
Known history of drug abuse or chronic alcohol consumption
Women who were pregnant or breast feeding, or female of childbearing potential who did not use an adequate method of contraception according to the investigator's judgment.
Active opportunistic infection or documented infection within the previous 4 weeks.
Documented active malignant disease (excluding Kaposi sarcoma limited to the skin).
Renal disease with creatinine clearance < 50 mL/min.
Concomitant use of nephrotoxic or immuno-suppressive drugs which could not be stopped without affecting the safety of the patient.
Receiving on-going therapy with systemic corticosteroids, Interleukin-2 or chemotherapy.
Patients who were not to be included in the study according to the investigator's criterion.
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1353
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
Patients who have been following a fat and cholesterol restrictive diet.

Exclusion Criteria:

Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
Abnormal pancreatic, liver, or renal function
Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
Significant heart disease
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 674
Group description: Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
Eligibility criteria:
Inclusion Criteria:

The subjects will be male and female smokers age 18-75.
Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

Planning a pregnancy, pregnant, or lactating
Current addiction to opiates, cocaine, or stimulants
Skin allergies or chronic dermatitis (based on medical history/self-report)
An Axis 1 major psychiatric disorder
Intervention: Fondaparinux
Trial phase: Phase 2 | Phase 3
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Eligibility criteria:
Inclusion Criteria:

Patients who are scheduled for elective Cardiac or Thoracic Surgery.
Age > 18 years of age.

Exclusion Criteria:

Patients with a clinical suspicion or a documented history of DVT/PE
Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
Documented allergy to heparin, desirudin, or lepirudin
Patients with a history of coagulation disorder
Platelet count< 100 X109 /dl
Active bleeding
Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min
Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec)
Patients with liver disease
Pregnancy
Patients who require ventricular assist devices before or after surgery
Intervention: Acamprosate
Trial phase: Phase 4
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Acamprosate tablets
Eligibility criteria:
Inclusion Criteria:

Adults ages 18-60
Meet DSM-IV criteria for current (past 90 days) alcohol dependence
Must identify alcohol as the primary substance of abuse
Meet DSM-IV criteria for a current major depressive episode, GAD and/or social anxiety disorder
Have a stable psychiatric condition, as evidenced by a baseline CGI change score of 4 or below between the time of initial screening and the baseline visit, and if receiving psychotropic medication, must have a stable dose of medication for at least one month prior to baseline.
Must have a negative urine drug screen at the baseline visit; UDS may be repeated no more that twice to obtain an negative UDS
May be receiving medication treatment for anxiety/mood disorder as long as the dosage has been stable for 4 weeks prior to randomization.
May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety disorders.
Must abstain from alcohol for at least 3 consecutive days but no more than 21 days prior to medication initiation
Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
Subjects must consent to random assignment, be willing to commit to medication treatment and follow-up assessments
CIWA-Ar scale is 8 or less at the baseline visit

Exclusion Criteria:

Individuals with a primary psychotic disorder or bipolar disorder
Individuals who meet DSM-IV criteria for current (past 90 days) dependence on substances other than alcohol, caffeine or nicotine
Individuals with an uncontrolled neurologic condition that could confound the results of the study
Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
Regular use of benzodiazepines for the treatment of psychiatric symptoms (as defined as more than 12 times in the month prior to the screening visit)
Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention of alcohol relapse
Women of childbearing potential who are lactating or refuse to use adequate forms of birth control
Current suicidal or homicidal risk
Intervention: Acamprosate
Trial phase: Phase 4
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Matching placebo tablets
Eligibility criteria:
Inclusion Criteria:

Adults ages 18-60
Meet DSM-IV criteria for current (past 90 days) alcohol dependence
Must identify alcohol as the primary substance of abuse
Meet DSM-IV criteria for a current major depressive episode, GAD and/or social anxiety disorder
Have a stable psychiatric condition, as evidenced by a baseline CGI change score of 4 or below between the time of initial screening and the baseline visit, and if receiving psychotropic medication, must have a stable dose of medication for at least one month prior to baseline.
Must have a negative urine drug screen at the baseline visit; UDS may be repeated no more that twice to obtain an negative UDS
May be receiving medication treatment for anxiety/mood disorder as long as the dosage has been stable for 4 weeks prior to randomization.
May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety disorders.
Must abstain from alcohol for at least 3 consecutive days but no more than 21 days prior to medication initiation
Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
Subjects must consent to random assignment, be willing to commit to medication treatment and follow-up assessments
CIWA-Ar scale is 8 or less at the baseline visit

Exclusion Criteria:

Individuals with a primary psychotic disorder or bipolar disorder
Individuals who meet DSM-IV criteria for current (past 90 days) dependence on substances other than alcohol, caffeine or nicotine
Individuals with an uncontrolled neurologic condition that could confound the results of the study
Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
Regular use of benzodiazepines for the treatment of psychiatric symptoms (as defined as more than 12 times in the month prior to the screening visit)
Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention of alcohol relapse
Women of childbearing potential who are lactating or refuse to use adequate forms of birth control
Current suicidal or homicidal risk
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: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management

Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.

Risperidone in Long-Acting Injectable Form (Consta): Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
First major episode of psychotic symptoms occurred within 2 years prior to study entry
Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

Exclusion Criteria:

Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
Mental retardation (e.g., premorbid IQ less than 70)
Significant alcohol or substance abuse within 6 months prior to study entry
Inability to complete research measures in English
Any condition that may make risperidone use medically inadvisable
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: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Participants taking daily oral risperidone, plus group skills training and case management

Group Skills Training and Psychoeducation: Group skills training sessions will be weekly throughout the study. The sessions will include group therapy meetings focused on everyday living skills, family education about schizophrenia, assessments of medication response, and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

Individual Case Management: An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.

Oral Risperidone: Daily oral risperidone dosage will determined by treating psychiatrist.
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
First major episode of psychotic symptoms occurred within 2 years prior to study entry
Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

Exclusion Criteria:

Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
Mental retardation (e.g., premorbid IQ less than 70)
Significant alcohol or substance abuse within 6 months prior to study entry
Inability to complete research measures in English
Any condition that may make risperidone use medically inadvisable
Intervention: Salsalate
Trial phase: Phase 2 | Phase 3
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred.
Eligibility criteria:
Inclusion Criteria:

Male and female veterans between the age of 21-75 who have IFG (impaired fasting glucose) and/or IGT

Exclusion Criteria:

any diabetes therapy in the prior 12-months period
any acute illness
Ongoing high dose aspirin or Salsalate Therapy
history of GI bleeding
hearing problems
poor vascular access, prior pancreatitis, uncontrolled hypertension, pregnancy, renal disease or anemia
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Participants assigned to receive long-acting injectable risperidone

Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
Eligibility criteria:
Inclusion Criteria:

All schizophrenia and schizoaffective patients whose clinicians are considering long-term treatment with an "atypical" (second generation) antipsychotic medication
Worsening of illness (schizophrenia) within 12 months of study entry as defined by: hospitalization, increased level of clinical care, and/or present clinical Global Impressions Severity rating of moderate or worse

Exclusion Criteria:

First episode patients as defined by a patient who: has never received antipsychotic medication and has never been hospitalized for psychiatric illness; or, is receiving antipsychotic medication for the first time associated with a first diagnosis of schizophrenia.
Pregnant or breastfeeding
Patients with unstable medical conditions
Patients with previous history of failure to respond to an adequate trial of clozapine
Patients with a known allergy to risperidone or a previous history of failure to respond to an adequate trial of risperidone. However, patients with known allergies or failure to respond to any of the other medications (aripiprazole, olanzapine, quetiapine or ziprasidone) will not receive that medication if they are randomized to the oral medication arm, but are not excluded from the study
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 449
Group description: Pitavastatin 2 mg once daily
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 65 years of age
Primary hypercholesterolemia
Combined dyslipidemia
Completed study NK-104-306 (NCT00257686)

Exclusion Criteria:

Failed to complete study NK-104-306(NCT00257686)
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 65 years of age
Primary hypercholesterolemia
Combined dyslipidemia
Completed study NK-104-306 (NCT00257686)

Exclusion Criteria:

Failed to complete study NK-104-306(NCT00257686)
Intervention: Pemetrexed
Trial phase: Phase 2
ATC code: L01BA04
SMILES: Nc1nc(=O)c2c(CCc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)c[nH]c2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Eligibility criteria:
Inclusion Criteria:

no prior therapy for rectal cancer
pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
signed informed consent
at least 18 years of age
surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.

Exclusion Criteria:

concurrent administration of any other anti-tumor therapy
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
serious concomitant systemic disorders
previously completed or withdrawn from this study
pregnant or breast-feeding
second primary malignancy
history of significant neurological or mental disorder, including seizures or dementia
inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
Intervention: Duloxetine
Trial phase: Phase 2
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Eligibility criteria:
Inclusion Criteria:

ages 18-65
primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and assessed by the MINI International Neuropsychiatric Interview
Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline
Minimum Clinical Global Impressions of Severity (CGS) severity score of 4
Ability to provide written consent form
A negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition
History of substance abuse or dependence within the last 6 months
Suicide risk or serious suicide attempt within the last year
Clinically significant medical condition or laboratory abnormality
Women of childbearing potential who are unwilling to practice an acceptable method of contraception
Subjects needing concurrent use of psychotropic medications
History of sensitivity to duloxetine
History of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks)
Subjects taking monoamine oxidase inhibitors (MAOIs)
Subjects with uncontrolled narrow-angle glaucoma
Intervention: Betamethasone
Trial phase: Phase 2 | Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Dexamethasone 350 µg
Eligibility criteria:
Inclusion Criteria:

18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

Uncontrolled systemic disease
Any active ocular infections
Intervention: Betamethasone
Trial phase: Phase 2 | Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Dexamethasone 700 µg
Eligibility criteria:
Inclusion Criteria:

18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

Uncontrolled systemic disease
Any active ocular infections