anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 4 weeks of adjunctive treatment
Eligibility criteria:
Inclusion Criteria:

Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or schizoaffective disorder
PANSS 3 factor negative symptom inclusion score greater than 20 prior to study entry
PANSS total score between 60 and 110
Simpson-Angus Scale total score of 12 or less
Calgary Depression Inventory total score of 10 and suicide score less than 2
No change in Clinical Global Impressions (CGI) Scale score prior to study entry
Chlorpromazine (CPZ) equivalent of 1500 or less
Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

High extrapyramidal symptom (EPS) levels
Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
Taking investigational medication within 2 weeks of study entry
Contraindication to study medication
Serious or unstable medical illness
Pregnant or breastfeeding
Alcohol or drug abuse within 6 months of study entry
Diagnosed with neurodegenerative disease or a seizure disorder
History of a kidney impairment
Currently taking clozapine
Currently taking more than two antipsychotic medications
Currently taking stimulants or cholinesterase inhibitors
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 4 weeks of adjunctive treatment
Eligibility criteria:
Inclusion Criteria:

Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or schizoaffective disorder
PANSS 3 factor negative symptom inclusion score greater than 20 prior to study entry
PANSS total score between 60 and 110
Simpson-Angus Scale total score of 12 or less
Calgary Depression Inventory total score of 10 and suicide score less than 2
No change in Clinical Global Impressions (CGI) Scale score prior to study entry
Chlorpromazine (CPZ) equivalent of 1500 or less
Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

High extrapyramidal symptom (EPS) levels
Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
Taking investigational medication within 2 weeks of study entry
Contraindication to study medication
Serious or unstable medical illness
Pregnant or breastfeeding
Alcohol or drug abuse within 6 months of study entry
Diagnosed with neurodegenerative disease or a seizure disorder
History of a kidney impairment
Currently taking clozapine
Currently taking more than two antipsychotic medications
Currently taking stimulants or cholinesterase inhibitors
Intervention: Mirtazapine
Trial phase: Phase 2
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Mirtazapine daily:

Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
Eligibility criteria:
Inclusion Criteria:

Diagnostic Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of cocaine dependence.
HAM-D score of 12 or above and history of autonomous depression, defined as meeting DSM-IV criteria for major depression or dysthymic disorder during any lifetime period of abstinence of 30 days or longer.
At least one urine toxicology positive for cocaine benzoylecgonine (BE) over the consecutive two-week baseline screening period during which 6 urine samples have been obtained
Males and non-pregnant, non-nursing females, 18-64 years of age (inclusive).
Individuals able to give written informed consent and willing to comply with all study procedures.

Exclusion Criteria:

Any Axis I diagnosis that, in the opinion of the Principal Investigator, may interfere with the course of the trial.
Physiological dependence on alcohol or opiates requiring medical detoxification.
A medical or neurological illness that in the clinical judgment of the investigator would make study compliance difficult or contraindicate the use of mirtazapine.
Any clinically significant abnormal lab values or liver function tests (LFTs) which are greater than 3 times the normal limit.
The need or intention to use concurrently with or within four weeks prior to study drug administration, any of the following medications: monoamine oxidase inhibitors and/or sibutramine. In addition, other medications such as alpha2-agonists and medications which affect the enzymes Cytochrome P450 1A2 (CYP1A2), Cytochrome P450 2D6 (CYP2D6), Cytochrome P450 3A4 (CYP3A4) (as inhibitors, substrates, or inducers), and serotonin modulators should be used with caution. The research physician will decide on this issue. A listing of these substances may be found in Appendix I.
Females of childbearing potential who do NOT agree to use a medically acceptable method of birth control (barrier, intrauterine device (IUD), oral or depot contraceptive medication, or complete abstinence).
Positive pregnancy test.
Breastfeeding
Known drug allergy or sensitivity to mirtazapine.
Participation in an investigational drug or device study within 1 month of enrollment in the present study.
Enrollment in an opiate-substitution (i.e., methadone, levo acetyl methadol (LAAM)) treatment program within 45 days of enrolling in the present study.
Individuals having taken LAAM, methadone or naltrexone within 14 days of enrollment in the present study.
Individuals who, in the clinical judgment of the Investigator, are actively and acutely suicidal.
Subjects, who in the opinion of the investigator, have a medical condition that may interfere with study assessments and/or put them at undue risk.
Subjects, who in the opinion of the investigator, will have difficulty complying with study procedures.
Intervention: Gefitinib
Trial phase: Phase 3
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 607
Group description: Gefitinib 250mg daily
Eligibility criteria:
Inclusion Criteria:

Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)

Exclusion Criteria:

Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
Intervention: Plerixafor
Trial phase: Phase 2
ATC code: L03AX16
SMILES: c1cc(CN2CCCNCCNCCCNCC2)ccc1CN1CCCNCCNCCCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
No more than 3 prior regimens of chemotherapy
More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
White blood cell (WBC) count >3.0*10^9/L
Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
Platelet (PLT) count >100*10^9/L
Serum creatinine <=2.2 mg/dL
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
Negative for human immunodeficiency virus (HIV)
Women of child bearing potential who agreed to use an approved form of contraception.

Exclusion Criteria:

Patients who have failed previous collections
Brain metastases or carcinomatous meningitis
History of ventricular arrhythmias
History of paresthesias
A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
A residual acute medical condition resulting from prior chemotherapy
Acute infection
Fever (temp >38°C/100.4°F)
Patients whose actual body weight exceeds 150% of their ideal body weight
Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
Positive pregnancy test in female patients
Lactating females
Patients of child-bearing potential unwilling to implement adequate birth control.
Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Intervention: Plerixafor
Trial phase: Phase 2
ATC code: L03AX16
SMILES: c1cc(CN2CCCNCCNCCCNCC2)ccc1CN1CCCNCCNCCCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
No more than 3 prior regimens of chemotherapy
More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
White blood cell (WBC) count >3.0*10^9/L
Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
Platelet (PLT) count >100*10^9/L
Serum creatinine <=2.2 mg/dL
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
Negative for human immunodeficiency virus (HIV)
Women of child bearing potential who agreed to use an approved form of contraception.

Exclusion Criteria:

Patients who have failed previous collections
Brain metastases or carcinomatous meningitis
History of ventricular arrhythmias
History of paresthesias
A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
A residual acute medical condition resulting from prior chemotherapy
Acute infection
Fever (temp >38°C/100.4°F)
Patients whose actual body weight exceeds 150% of their ideal body weight
Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
Positive pregnancy test in female patients
Lactating females
Patients of child-bearing potential unwilling to implement adequate birth control.
Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally,30 mg, once daily for 28 days
Eligibility criteria:
Inclusion Criteria:

Male or female >= 28 years of age
Confirmed diagnosis of cystic fibrosis
Forced Expiratory Volume in 1 second (FEV1) >= 40% predicted
Clinically stable
Ability to reproduce spirometry
Ability to understand and sign the informed consent

Exclusion Criteria:

Use of an investigational agent within 4-week period prior to Visit 1
Chronic daily use of ibuprofen or other NSAIDS
Chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents
History of hypersensitivity to beta agonists
History of hypersensitivity to glitazones
Oxygen saturation<92%
Pregnant, breastfeeding or unwilling to practice acceptable birth control
History of hemoptysis >30cc per episode within 30 days prior to Visit 1
Significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease
Serum Glutamic-Oxaloacetic Transaminase (SGOT)/(Serum Glutamic Pyruvic Transaminase (SGPT) >3 times the upper limit of normal at screening, documented biliary cirrhosis,or portal hypertension
Creatinine > 1.8 mg/dL at screening
Inability to swallow pills
Presence or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data
Subjects who have routinely taken ibuprofen or other NSAIDS; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded
Intervention: Meglumine gadobenate
Trial phase: Phase 3
ATC code: V08CA08
SMILES: CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO.O=C([O-])CN(CCN(CC(=O)[O-])CC(=O)[O-])CCN(CC(=O)[O-])C(COCc1ccccc1)C(=O)[O-].[Gd+3].[H+].[H+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 92
Group description: Contrast Agent, 0.10 mmol/kg injection
Eligibility criteria:
Inclusion Criteria:

Between 2 and 17 years of age
Informed consent from parents
Assent from patient where required
Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination

Exclusion Criteria:

Contraindication to MRI
Undergoing MRI in an emergency situation
Known allergy to one or more of the ingredients in MultiHance
Sickle cell anemia moderate to severe renal impairment
Received another investigational compound within 30 days
Pregnancy
Lactating females
Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
Intervention: Anastrozole
Trial phase: Phase 4
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Anastrozole 1 mg once daily
Eligibility criteria:
Inclusion Criteria:

Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
WHO performance status 0, 1 or 2
Provision of written informed consent

Exclusion Criteria:

Recurrence of breast cancer, inflammatory rheumatism
treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
Diabetes treated by insulin
Severe renal or hepatic disease
Known hypersensitivity to anastrozole
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: 47
Group description: Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
Eligibility criteria:
Inclusion Criteria:

Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening
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: 72
Group description: Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the "maintain baseline regimen" group in Study Phase 2).
Eligibility criteria:
Inclusion Criteria:

Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening
Intervention: Zidovudine
Trial phase: Phase 2
ATC code: J05AF01 | J05AR01 | J05AR04 | J05AR05
SMILES: Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
Eligibility criteria:
Inclusion Criteria:

1) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.

Exclusion Criteria:

Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having received Rituximab within 6 months.
Patients will not be entered while febrile (Temperature > 38 degrees C) within 1 week.
Active infection.
Patients with known Human immunodeficiency virus (HIV) infection.
Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine.
Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.
Patients who have previously received pneumococcal vaccine within the preceding 12 months.
Absolute lymphocyte count less than 500 cells/mm3.
Intervention: Tolterodine
Trial phase: Phase 4
ATC code: G04BD07
SMILES: Cc1ccc(O)c([C@H](CCN(C(C)C)C(C)C)c2ccccc2)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Tolterodine 4 mg q.d. X 8 weeks
Eligibility criteria:
Inclusion Criteria:

Post-menopausal women, age 45 to 65 years old.
No menses for at least 6 months before the study start.
Have at least 14 episodes of nocturia per week.
Have at least 4 hot flashes daily.
Overall good health, as evidenced by a letter from the primary care provider.
Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Exclusion Criteria:

Use of anti-cholinergic, hypnotic or sedating drugs
Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
A urinary tract infection within a month of study start.
Undiagnosed abnormal vaginal bleeding.
Benign or malignant liver disease.
History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
An acute systemic infection within seven days before the study start.
Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.

History of shift work within the past 6 months.

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Intervention: Tolterodine
Trial phase: Phase 4
ATC code: G04BD07
SMILES: Cc1ccc(O)c([C@H](CCN(C(C)C)C(C)C)c2ccccc2)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
Eligibility criteria:
Inclusion Criteria:

Post-menopausal women, age 45 to 65 years old.
No menses for at least 6 months before the study start.
Have at least 14 episodes of nocturia per week.
Have at least 4 hot flashes daily.
Overall good health, as evidenced by a letter from the primary care provider.
Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Exclusion Criteria:

Use of anti-cholinergic, hypnotic or sedating drugs
Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
A urinary tract infection within a month of study start.
Undiagnosed abnormal vaginal bleeding.
Benign or malignant liver disease.
History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
An acute systemic infection within seven days before the study start.
Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.

History of shift work within the past 6 months.

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Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
Eligibility criteria:
Inclusion Criteria:

Either sex aged 65 or above
Diagnosis of OA of the hip and/or knee
Severe pain requiring step two medication
Taking maximum dose of paracetamol

Exclusion Criteria:

Painful disease of the joints other than OA
Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
Subjects taking cyclooxygenase (COX) II selective inhibitors