anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Raltegravir
Trial phase: Phase 3
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: 20
Group description: This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months

raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Eligibility criteria:
Inclusion Criteria:

Age >18
Fasting LDL>130 mg/dL
Fasting triglycerides >250 mg/dL
Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
No prior history of any NRTI resistance.

Exclusion Criteria:

History of NRTI resistance mutations
Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
Breast-feeding or pregnancy.
Use of immunosuppressive medications within 60 days prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Intervention: Citalopram
Trial phase: Phase 3
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: 30
Group description: Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Eligibility criteria:
Inclusion Criteria:

age 18 to 65 years,
DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder
confirmed stable HIV disease and attending a HIV treatment program
stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks
ability to give informed consent

Exclusion Criteria:

bipolar disorders, any psychotic disorder
current major depression
substance dependence (except nicotine dependence) in the previous 3 months
currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes)
any hospitalization for HIV-related illness in the previous 3 months
any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV
current active treatment for opportunistic infections related to HIV
any psychotropic drug treatment in the previous 2 weeks before screening
history of hypersensitivity to escitalopram and/or citalopram
admission BDI 23
seizure disorder, traumatic brain injury
pregnant, nursing mother or planning to get pregnant.
Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications.
In the opinion of the investigator the clinical condition precludes participation in the trial.
Intervention: Sitagliptin
Trial phase: Phase 1
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
Eligibility criteria:
Inclusion Criteria:

Subject is an Asian Indian male between 18 to 45 years of age
Subject is in good health
Subject is a nonsmoker or has not used nicotine-containing products for six months
Subject is willing to avoid strenuous activity

Exclusion Criteria:

Subject has a history of stroke, seizures, or major neurological disorders
Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
Subject has a history of high blood pressure requiring treatment
Subject has history of cancer
Subject has a history of diabetes
Intervention: SODIUM BICARBONATE
Trial phase: Phase 2 | Phase 3
ATC code: B05CB04 | B05XA02
SMILES: O=C([O-])O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Crossover design. Participants will be getting different doses of sodium bicarbonate during the study.

Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight
Eligibility criteria:
Inclusion Criteria:

Estimated GFR < 45 ml/min/1.73m2 and >15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
Age >21

Exclusion Criteria:

Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
Bicarbonate level <20 or >25 mEq/L
Decompensated heart failure
Systolic blood pressure >160 mm/Hg
Moderate or greater lower extremity edema
Initiation of ESRD treatment planned within 6 months
Kidney transplantation
Treatment with immunosuppressives within the last 3 months
Intervention: Aprepitant
Trial phase: Phase 4
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: 40 mg aprepitant
Eligibility criteria:
Inclusion Criteria:

Scheduled for elective hysterectomy at Mayo Clinic in Arizona
ASA I, II, or III

Exclusion Criteria:

Pregnancy
Concomitant bowel surgery other than appendectomy
Hypersensitivity to study drug or rescue medication
Preoperative score for nausea greater than 4 out of 10 points
Severe hepatic insufficiency (Child-Pugh score > 9)
Any condition which impairs the patient's ability to complete study assessments
Intraoperative hemodynamic instability
ICU admission
Prolonged postoperative intubation
Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
Other antiemetic within 12 hours prior to surgery
Participation in a clinical trial using an investigational product
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Tarceva: Tarceva 150 mg/day

Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years
Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
Performance status ≤2 on the ECOG scale
Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
ALAT ≤2 x ULN
Able to comply with study and follow-up procedures
Patients with reproductive potential must use effective contraception
Written (signed) informed consent to participate in the study

Exclusion Criteria:

Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
Inability to take oral medication, or requirement of intravenous alimentation
Nursing mothers
Intervention: 3,3'-Diindolylmethane
Trial phase: Phase 2
SMILES: c1ccc2c(Cc3c[nH]c4ccccc34)c[nH]c2c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy

B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prosatectomy
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the prostate

Stage I or II (T1-T2 a, b, or c) disease
Disease confined to the prostate by clinical judgment of the surgeon
Deemed an appropriate candidate for surgery by clinical judgment of the surgeon

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN if AST and/or ALT normal
Serum creatinine ≤ 2.0 mg/dL
No history of allergic reactions attributed to compounds of similar chemical or biological composition to oral microencapsulated diindolylmethane

No concurrent uncontrolled illness including, but not limited to, any of the following:

Ongoing or active infection
Symptomatic congestive hart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

No prior chemotherapy, hormonal therapy, brachytherapy, cryotherapy, external beam radiotherapy, or other therapy for prostate cancer
No concurrent micronutrient supplements or dietary soy products
No concurrent systemic therapy for any other cancer
No concurrent p450 inducers or inhibitors (e.g., carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, or rifampin)
No concurrent finasteride or dutasteride
No other concurrent investigational or commercial agents or therapies for the malignancy
Intervention: Zopiclone
Trial phase: Phase 4
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: 12
Group description: Standard dosing of drug for 6 weeks for insomnia

eszopiclone : 6 weeks standard oral therapy
Eligibility criteria:
Inclusion Criteria:

Mild to Moderate Insomnia

Exclusion Criteria:

Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders)
Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks)
Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone)
History of a significant adverse reaction to eszopiclone
Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months
Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures
Limited mental competency and the inability to give informed, voluntary, written consent to participate.
Intervention: Pitavastatin
Trial phase: Phase 4
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: 81
Group description: Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
Eligibility criteria:
Inclusion Criteria:

Age: 25yrs~75yrs
Fasting TG <400mg/dL, LDL-C ≥130mg/dL
3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

Type1 DM, Gestational diabetes
Patient need to treat with Insulin
Patient with operational treatment for severe diabetic complication
Uncontrolled Hypothyroidism
Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
Renal disorder (Serum creatinine ≥ 2.0mg/dL)
Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
Creatinine Kinase > 2.5 X UNL
Gravida or lactation phase
Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Intervention: Atorvastatin
Trial phase: Phase 4
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: 70
Group description: Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Eligibility criteria:
Inclusion Criteria:

Age: 25yrs~75yrs
Fasting TG <400mg/dL, LDL-C ≥130mg/dL
3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

Type1 DM, Gestational diabetes
Patient need to treat with Insulin
Patient with operational treatment for severe diabetic complication
Uncontrolled Hypothyroidism
Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
Renal disorder (Serum creatinine ≥ 2.0mg/dL)
Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
Creatinine Kinase > 2.5 X UNL
Gravida or lactation phase
Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Intervention: Alcaftadine
Trial phase: Phase 3
ATC code: S01GX11
SMILES: CN1CCC(=C2c3ccccc3CCn3c(C=O)cnc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Eligibility criteria:
Inclusion Criteria:

At least 10 years of age
positive history of ocular allergies
positive skin test reaction to allergens.

Exclusion Criteria:

known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
ocular surgical intervention within three (3) months prior to visit 1 or during the study
known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
any other significant illness
Intervention: Apremilast
Trial phase: Phase 1 | Phase 2
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patient receiving apremilast.
Eligibility criteria:
Inclusion Criteria:

patients with vision-threatening autoimmune uveitis
failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects

Exclusion Criteria:

serious concomitant illness that could interfere with the subject's participation
previous or current use of an alkylating agent
use of CYP3A4 inhibitors during the trial
TNF blocker use within the 8 weeks prior to enrollment
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
Eligibility criteria:
Inclusion Criteria:

Smokers motivated to stop smoking scheduled for elective surgery

Exclusion Criteria:

Current or recent depression
Current or recent suicidal ideation
Uncontrolled or unstable clinically significant medical condition
Intervention: Prednisone
Trial phase: Phase 1
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Prednisone taken:

20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).

Prednisone: Prednisone taken:

20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:

Non-small cell lung carcinoma

Stage I disease
Primary disease
No primary lung metastatic disease, satellite lesions of the chest, mediastinal lymph nodes > 1.5 cm, hepatic or adrenal masses by the PET scan or the CT scan

Metastatic cancer to the lung

Must have a definitive cancer diagnosis with the primary tumor under local control and no metastatic disease other than to the lung
Solitary or multiple (≤ 3) peripheral lung lesions
No chemotherapy since the new metastatic lesion appeared
Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by conventional CT scan techniques
Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne State University
Must be a candidate for a thoracotomy
No evidence of cerebral disease or metastatic disease of the brain

PATIENT CHARACTERISTICS:

Neutrophil count > 1,500/mm^3
Platelet count > 75,000/mm^3
PT and PTT normal
FEV_1 > 1.0 L/sec
Diffusing capacity ≥ 30%
Not pregnant or nursing

No other uncontrolled or concurrent illnesses including, but not limited to, any of the following conditions:

Active infection
Heart failure
Unstable angina
Cardiac dysrhythmia
Psychiatric illness or a social situation that would limit compliance with the study requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiation therapy or chemotherapy for these particular tumors
No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)
No other concurrent experimental studies
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
Eligibility criteria:
Inclusion Criteria:

Age > 18 years of age at the Screening visit
American Society of Anesthesiologists (ASA) class 1-3
Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique
For female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery
Clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
Able to speak, read, and understand the language of all subject-facing documents, including the ICF and study questionnaires
Able and willing to comply with all study visits and procedures

Exclusion Criteria:

Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component
Body weight less than 50 kilograms (110 pounds)
History of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol
Current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug [NSAID], opioid, selective serotonin reuptake inhibitor [SSRI], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments
Concurrent fissurectomy
Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery
Use of acetaminophen within 24 hours of surgery
Chronic users of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
Current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study
HIV infection or hepatitis
Currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration
Any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial
Subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives
Previous participation in a SKY0402 study
Failure to pass drug and alcohol screen
Intervention: FLUTICASONE FUROATE
Trial phase: Phase 4
ATC code: R01AD12 | R03AK10 | R03AL08 | R03BA09
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
Eligibility criteria:
Inclusion Criteria:

a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
positive skin prick test to tree and / or grass

Exclusion Criteria:

glaucoma
cataracts
acute or chronic sinusitis
asthma
chronic obstructive pulmonary disease
physical nasal obstruction
pregnant or breastfeeding
have had a viral or bacterial infections within 2 weeks of the study commencement
receiving allergen immunotherapy
have used inhaled corticosteroids within 14 days prior to the study
have used systemic corticosteroids within 30 days of the study
travel outside of the geographic area during the 2 week study period
use of contact lenses during the study period
use of artificial tears during the study period
use of eyewash irrigation during the study period
use of lubricants during the study period