anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pentoxifylline
Trial phase: Phase 4
ATC code: C04AD03 | R03DA20
SMILES: CC(=O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Patients receive Pentoxifylline 400 mg po TID for 8 weeks.

Pentoxifylline: 400mg PO TID x 8 weeks
Eligibility criteria:
Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl

Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer
Intervention: Zopiclone
Trial phase: Phase 2 | Phase 3
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
Eligibility criteria:
Inclusion Criteria:

Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week

Participants who meet both of the following based on polysomnogram (PSG) in observation period:

Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
Participants with organic mental disorder.
Intervention: Zopiclone
Trial phase: Phase 2 | Phase 3
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
Eligibility criteria:
Inclusion Criteria:

Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week

Participants who meet both of the following based on polysomnogram (PSG) in observation period:

Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
Participants with organic mental disorder.
Intervention: Zopiclone
Trial phase: Phase 2 | Phase 3
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
Eligibility criteria:
Inclusion Criteria:

Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week

Participants who meet both of the following based on polysomnogram (PSG) in observation period:

Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
Participants with organic mental disorder.
Intervention: Zolpidem Tartrate
Trial phase: Phase 2 | Phase 3
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
Healthy volunteers: No
Participants at risk: 70
Group description: Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
Eligibility criteria:
Inclusion Criteria:

Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week

Participants who meet both of the following based on polysomnogram (PSG) in observation period:

Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
Participants with organic mental disorder.
Intervention: Gefitinib
Trial phase: Phase 4
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: 147
Group description: Gefitinib (Iressa® 250 mg) 1 tablet daily
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable
Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria.
The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.

Exclusion Criteria:

Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225)
Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 80 mg atorvastatin daily for 3 weeks

lipitor: 80 mg everyday (QD) for 3 weeks
Eligibility criteria:
Inclusion Criteria:

Age 40-90
Male or female
Type 2 diabetes

Exclusion Criteria:

Known pregnancy or nursing.
Females of child bearing potential must have been surgically sterilized or be post menopausal.
Smoking
Known vascular disease
Inability to complete MRI scan
Symptoms of claudication
Use of a nitrate medicine
Use of any cholesterol-lowering agent
LDL < 70
Acute illness
Liver disease
Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
Meet criteria for stage I or II hypertension
Currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

Secondary hypertension
Are taking three or more antihypertensive agents
Have uncontrolled or poorly controlled diabetes mellitus type I or type II
Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
Participation in any investigational study within 30 days of Screening (Visit 1).
Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
Intervention: Ertapenem
Trial phase: Phase 3
ATC code: J01DH03
SMILES: [H][C@@]1(SC2=C(C(=O)O)N3C(=O)[C@]([H])([C@@H](C)O)[C@@]3([H])[C@H]2C)CN[C@]([H])(C(=O)Nc2cccc(C(=O)O)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
Eligibility criteria:
Inclusion Criteria:

Patient has a clinically suspected and /or bacteriologically documented complicated UTI or acute pyelonephritis judged by the investigator to be serious
Patient has one positive urine culture within 48 hours of enrollment
Patient has one or more signs or symptoms of either upper or lower UTI
Patient is male with or without a bladder catheter or urologic abnormalities; OR patient is a female with a history or clinical evidence of one or more urologic abnormalities

Exclusion Criteria:

Patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics
Patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study
Patient has complete obstruction of any portion of the urinary tract. Patient has a history of seizures other than an uncomplicated febrile seizure
Intervention: Tauroursodeoxycholic acid
Trial phase: Not Applicable
ATC code: A05AA05
SMILES: [H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@]3(C)[C@@H]([C@H](C)CCC(=O)NCCS(=O)(=O)O)CC[C@@]3([H])[C@]1([H])[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: Subjects will receive tauroursodeoxycholic acid for four weeks.

tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.
Eligibility criteria:
Inclusion Criteria:

BMI range 30 to 45
sedentary (defined as regular exercise < 1 h per week or < 2 x/week for the last 6 months)

Exclusion Criteria:

active or previous infection with hepatitis B or C
liver diseases
history of alcohol abuse
current alcohol consumption > 20 g/day
severe hypertriglyceridemia ( > 400 mg/dL)
active peptic ulcer disease
taking cholestyramine or oral contraceptives
women who are pregnant or lactating
Intervention: Daptomycin
Trial phase: Phase 3
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: daptomycin 4mg/kg iv every 24hours
Eligibility criteria:
Inclusion Criteria:

Provision of inform consent
A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Exclusion Criteria:

Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)
Intervention: Ramipril
Trial phase: Phase 4
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: No
Participants at risk: 193
Group description: Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Eligibility criteria:
Inclusion Criteria:

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Male or female outpatients, 18 years of age and older.
Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Study Visit 5 (randomization).
Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Exclusion Criteria:

Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
History or evidence of a secondary form of hypertension.
Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
Patients on 4 or more antihypertensive medications.
Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Raltegravir and Hyper-immune Bovine Colostrum placebo
Eligibility criteria:
Inclusion Criteria:

Documented HIV-1 infection
Age >18 years
Signed informed consent
Receiving combination ART (cART) for at least 12 months with a stable cART regimen for a minimum of 6 months. A formulation change or modification of dosage schedule is acceptable (for example ritonavir - boosted lopinavir capsules for tablets, abacavir (ABC) or tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC) as single agents for ABC/3TC or TDF/FTC fixed dose combinations)
Two consecutive plasma HIV RNA viral load measurements <50 (or <400 copies/mL depending upon lowest level of detection of the local assay) in the 9 months preceding the screening visit. A single isolated HIV RNA viral load >50 (or >400) copies/mL will not exclude the patient provided the viral load result >50 (or 400) copies/mL on therapy follows a previous result <50 (or 400) copies/mL, and there is a follow-up result <50 copies/mL at least one week following the >50 (or 400) copies/mL reading in the absence of a change to any component of the ART regimen.
CD4+ T cell count <350 cells/µL throughout the 6 months preceding the screening visit with <50 cells/µL increase in the last 12 months

Exclusion Criteria:

Receiving a cART regimen containing an integrase inhibitor
Anticipated change of cART in the 24 weeks following randomisation
Participating in study with an investigational compound or device within 30 days of signing informed consent
Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
Pregnant or breastfeeding woman
Cow's milk allergy
Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
A known cause of impaired CD4+ T cell gain: for example, patients with splenomegaly or individuals whose current cART regimen contains both tenofovir and didanosine
Intervention: Cyclosporine
Trial phase: Phase 2 | Phase 3
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 48 weeks treatment with ciclosporin

ciclosporin: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration
Eligibility criteria:
Inclusion Criteria:

Early (less than 2 years) HAM
Progressing (within past 3 months) HAM
Important to study the effect of therapy on disease that is most active as most likely to detect and measure improvement

Exclusion Criteria:

HIV infection
Tuberculosis, strongyloidiasis or other infection related to immune compromise
Hepatitis B & C viral infections
Malignancy
Intervention: Formoterol
Trial phase: Phase 4
ATC code: R03AC13 | R03AK07 | R03AK08 | R03AK09 | R03AK11 | R03AL05 | R03AL07 | R03AL09 | R03AL10 | R03AL11 | R03CC15
SMILES: COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Arformoterol twice daily for 1 week via nebulizer
Eligibility criteria:
Inclusion Criteria:

Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
Adults, age > 40 years
A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( < 0.70
Moderate, severe and very severe airflow limitation by GOLD criteria.
Clinically stable respiratory disease
The perceived ability to participate in pulmonary testing and exercise testing
COPD, stable state

Exclusion criteria:

Women of childbearing potential
Asthma
Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
A history of a prolonged QT interval
Recent exacerbation of COPD