anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria - Group I
Patients, men and women between 19 and 55 years of age, inclusive.
Patients with diagnosis of Posttraumatic Stress Disorder as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.).
Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
Patients, who signed the written informed consent given prior to entering any study procedure.
Inclusion Criteria - Group II
Patients, men and women between 19 and 55 years of age, inclusive.
Patients with diagnosis of Major Depression as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.). A diagnosis of PTSD will be exclusionary.
Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
Patients, who signed the written informed consent given prior to entering any study procedure.

Exclusion Criteria:

History of cardiovascular disease or a history of hypertension.
Patients with a concurrent Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis in any of the following categories as determined by the M.I.N.I.
Lifetime Schizophrenia and Schizoaffective Disorder
Lifetime Bipolar I Disorder
Substance Dependence or Abuse (excluding nicotine) within one month prior to the Screening Visit.
Patients with a history of intolerance or hypersensitivity to escitalopram or citalopram.
Patients who based on history or mental status examination have a significant risk of committing suicide. Current suicide risk (past month) will be assessed using the M.I.N.I. Suicidality Module. Subjects considered at high suicide risk based on the module (> 17 points) will be excluded from study participation.
Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
Subjects will be excluded who have a history of significant medical illness and who are on medications that affect cardiac and/or autonomic function.
Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
Eligibility criteria:
Inclusion Criteria:

primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

Women of childbearing potential previous glaucoma surgery presence of other eye disease
Intervention: Lapatinib
Trial phase: Phase 2
ATC code: L01EH01 | L01XE07
SMILES: CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed ER(-), PR(-), HER2(-) locally advanced or metastatic breast cancer
Disease progression following prior first line cytotoxic chemotherapy in metastatic setting
At least 1 lesion measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Age >18 years old
Female
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Left ventricular ejection fraction (LVEF) > 50%
Absolute neutrophil count (ANC)>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5x upper limit of normal (ULN); total bilirubin < 1.5x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN
Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

Patients with current active hepatic or biliary disease (except for patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Patients with an active infection or with a fever > 101.3 Fahrenheit within 3 days of the first scheduled day of protocol treatment
Patients with active central nervous system (CNS) metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia with two consecutive normal pap smears 6 months apart
Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received radiotherapy to target lesions within 4 weeks of entry
Patients who are receiving concurrent investigational therapy
Peripheral neuropathy >= Grade 2
Patients who are pregnant or lactating
Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
History of allogeneic transplant
Known HIV or Hepatitis B or C (active, previously treated or both)
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Intervention: Gentamicin
Trial phase: Phase 4
ATC code: D06AX07 | J01GB03 | S01AA11 | S02AA14 | S03AA06
SMILES: CNC(C)C1CCC(N)C(OC2C(N)CC(N)C(OC3OCC(C)(O)C(NC)C3O)C2O)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 276
Group description: Gentamicin arm: application of 80 mg gentamycin topically

Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose

No adverse effect
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of inguinal hernia

Exclusion Criteria:

Femoral hernia
Emergency cases
Intervention: Nilotinib
Trial phase: Phase 2
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: administered orally at a dose of 300 mg twice daily for 24 months
Eligibility criteria:
Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
First cytogenetic diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations within 6 months. Standard conventional cytogenetic analysis must be performed.
Previously untreated for CML, except for hydroxyurea and/or anagrelide (except imatinib treatment for max. 31 days long)
Adequate end organ function with following laboratory criteria: total bilirubin < 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x upper limit of normal (ULN); serum amylase and lipase ≤ 1.5 x upper limit of normal (ULN); alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) unless considered tumor related
Serum potassium, magnesium, and phosphorus levels are equal or above the lower limit of normal prior to the first dose of study medication

Exclusion Criteria:

Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of imatinib at any dose may be prescribed to the patient but for no longer than 31 days in duration)
Known cytopathologically confirmed Central Nervous System CNS infiltration
Impaired cardiac function
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection)
Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease
Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
History of significant congenital or acquired bleeding disorder unrelated to cancer
Previous radiotherapy to ≥25% of the bone marrow
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
Patients actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil)
Patients actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Leptin
Trial phase: Phase 1
SMILES: CSCCC(N=C(O)C(CC(=O)O)N=C(O)C(CCC(=N)O)N=C(O)C(CC(C)C)N=C(O)C(CO)N=C(O)CN=C(O)C(CCC(=N)O)N=C(O)C(N)CC(C)C)C(O)=NC(CC(C)C)C(O)=NC(Cc1c[nH]c2ccccc12)C(O)=NC(CCC(=N)O)C(O)=NC(CC(C)C)C(O)=NC(CC(=O)O)C(O)=NC(CC(C)C)C(O)=NC(CO)C(=O)N1CCCC1C(O)=NCC(O)=NC(CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: leptin: 0.01mg/kg
Eligibility criteria:
Inclusion Criteria:

For this pilot study we propose to enroll men and women, ages 18-65 years, with body mass index (BMI) ranges meeting lean and obese criteria, and less than or equal to 45 kg/m2. Obese diabetics will also be included.

Exclusion Criteria:

We will exclude subjects who require special diet prior to biopsy. We will exclude subjects with a history of any illness, other than obesity and diabetes. Subjects taking any medications that are known to influence glucose metabolism such as glucocorticoids will also be excluded. Subjects who have a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. coli-derived proteins or anesthetic agents such as Lidocaine or Novocaine will be excluded from the study. Women who are breast feeding, pregnant, or wanting to become pregnant during the month following the study may not participate in this study. Women participating in this study must use a contraceptive method to prevent pregnancy (birth control pills, hormonal implants, intrauterine device (IUD), diaphragm with intravaginal spermicide, cervical cap, male or female condom). If a woman suspects that she has become pregnant during the study or within one month of completing study, or if she does not use one of the contraceptive methods recommended by the investigator, she will be instructed to notify the study staff immediately. Subjects with a history of bleeding dyscrasia, poor wound healing or any medical condition precluding supine position will be excluded from the study.
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics

Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Eligibility criteria:
Inclusion Criteria:

18 yrs or older
increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr for 6 hours with the last 48hours)
written informed consent
patients with an indwelling bladder catheter

Exclusion Criteria:

Voluntary refusal
Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
history of renal transplant
Pregnant patients
Allergy / Sensitivity to Loop diuretics (furosemide)

Pre-renal AKI

defined by a Fractional Excretion of Sodium (FENa) of < 1% and no urinary casts
under-resuscitated as per the treating clinical team
active bleed

Post renal AKI

evidence of hydro-ureter
clinical scenario wherein obstruction is considered a likely possibility
Intervention: Bevenopran
Trial phase: Phase 2
SMILES: COc1cc(CNCCC2CCOCC2)ccc1Oc1cnc(C(N)=O)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
Eligibility criteria:
Key Inclusion Criteria

be a man or woman aged 18 to 75 years, inclusive, at the time of screening
have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg/m^2)
be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent total -daily dose for chronic noncancer pain for ≥30 days before screening
have opioid-induced constipation (OIC) by history. Additionally, based on the data collected during the 1-week screening period, participants must have <3 spontaneous bowel movements (SBMs) per week and have experienced ≥1 other bowel movement (BM) symptom (that is, straining to pass a stool, lumpy hard stools or small pellets, or sense of incomplete evacuation after passing a stool) for ≥25% of the total BMs
be willing to discontinue use of all laxatives and stool softeners during the study period except as allowed by the protocol

Key Exclusion Criteria

be pregnant, lactating, or planning to become pregnant during the study
have aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen, or serum creatinine results ≥2 times the upper limit of normal
have a recent history of myocardial infarction (MI) or unstable angina
have an active malignancy of any type
be taking opioids primarily for fibromyalgia
be taking methadone as a maintenance medication (participants taking methadone for pain may be enrolled)
be taking intrathecal opioids for the management of pain
be taking tramadol, tapentadol, or any mixed agonist/antagonist opioid analgesics as the sole opioid for analgesia
be taking any μ-opioid receptors (MOR) antagonist, including opioids in combination with naloxone, naltrexone, or methylnaltrexone bromide
be taking medical marijuana
have gastrointestinal (GI) or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
have taken antispasmodics, antidiarrheals, or prokinetics within 7 days before the start of the screening week
be taking nonopioid medications known to cause constipation
be taking antidiarrheals and have an incidence or a history of intermittent diarrhea or loose stools
be unwilling to abstain from grapefruit and grapefruit-containing products
have a history of alcoholism or illicit drug dependence or abuse within 5 years before screening
have positive results on a urine drug screen (excluding opioids) that indicate illicit drug use
Intervention: Maraviroc
Trial phase: Phase 2
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.

Maraviroc: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.

Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.

Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions.
Eligibility criteria:
Inclusion Criteria:

HIV-1 infected, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Active biopsy confirmed KS
Screening plasma HIV RNA < 75 copies/mL
Patients have unremitting KS. Unremitting is defined as having active biopsy confirmed KS in spite of having had sustained HIV RNA < 75 copies/mL for 24 prior months. Isolated values that are detectable but < 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable.
>90% adherence to therapy within the preceding 30 days, as determined by self-report.
Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
Concurrent treatment with immunomodulatory drugs or therapies, or exposure to any immunomodulatory drug or therapy in past 16 weeks.
Prior exposure to CCR5 inhibitors
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.
Elevated transaminases greater than 2.5 times the upper limit of normal.
Evidence of cirrhosis
Pregnant or breastfeeding women
Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
Local therapy for any KS index lesion in preceding 60 days, unless lesion has clearly progressed with enlargement since the local therapy
Intervention: Prednisolone
Trial phase: Not Applicable
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF
Fill out the case report form
Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis
Drug administration:

The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose.
Eligibility criteria:
Inclusion Criteria:

Male or female patient with clinical and pathological diagnoses of severe cutaneous adverse drug reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or Durg reaction with eosinophilia and systemic symptoms.
Male or female patient aged more than 4 years.
Inform consent obtained.

Exclusion Criteria:

Pregnant or breastfeeding female.
Allergic to any anti-TNF-α biological product.
Active or latent tuberculosis confirmed with Chest X-ray.
Severe active infection and septicemia.
Active Hepatitis B or C carrier.
Suspected HIV carrier with CD4 count less than 200.
Patient with poor compliance or with safety concerns judged by investigator.