anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Vaniprevir
Trial phase: Phase 1
SMILES: [H][C@@]1(C(=O)N[C@]2(C(=O)NS(=O)(=O)C3CC3)C[C@H]2CC)C[C@@H]2CN1C(=O)[C@H](C(C)(C)C)NC(=O)OCC(C)(C)CCCCc1cccc3c1CN(C3)C(=O)O2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.
Eligibility criteria:
Inclusion Criteria:

Subject is a man or a woman aged 18 to 55 years of age.
Subject has chronic Hepatitis C
Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

Patient has evidence of advanced liver disease.
Patient has human immunodeficiency virus (HIV)
Patient has Hepatitis B
Intervention: Vaniprevir
Trial phase: Phase 1
SMILES: [H][C@@]1(C(=O)N[C@]2(C(=O)NS(=O)(=O)C3CC3)C[C@H]2CC)C[C@@H]2CN1C(=O)[C@H](C(C)(C)C)NC(=O)OCC(C)(C)CCCCc1cccc3c1CN(C3)C(=O)O2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
Eligibility criteria:
Inclusion Criteria:

Subject is a man or a woman aged 18 to 55 years of age.
Subject has chronic Hepatitis C
Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

Patient has evidence of advanced liver disease.
Patient has human immunodeficiency virus (HIV)
Patient has Hepatitis B
Intervention: Quetiapine
Trial phase: Not Applicable
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
Eligibility criteria:
Inclusion Criteria:

Meet criteria for DSM-IV anorexia nervosa (restricting or binge-eating/purging types)
At least 15% below ideal body weight
Judged to be reliable to keep clinic visits and able to take all tests and examinations required by the protocol and be able to understand and decide whether or not to sign the Informed Consent.

Exclusion Criteria:

Subjects will not be included in the study who present with any of the following:

Schizophrenia or schizoaffective disorder (DSM-IV)
Any ECG abnormality considered clinically significant by the investigator
Subjects with liver enzymes elevated two times or more above normal
Other laboratory abnormalities considered clinically significant by the investigator including laboratory deviations requiring acute medical intervention
Pregnant women, women of childbearing potential not using medically accepted means of contraception (abstinence, IUD, birth control pills, barrier devices or implanted progesterone rods stabilized for at least three months), and lactating women
Serious suicide risk
Any medical condition that would preclude the outpatient treatment of anorexia nervosa or the use of quetiapine
Organic brain disease
History of severe allergies
Multiple adverse drug reactions or known allergy to quetiapine
Use of neuroleptic medications (except benzodiazepines) within 7 days preceding randomization
History of alcohol or substance abuse disorder as defined in the DSM-IV within the past 3 months.
Intervention: Nilotinib
Trial phase: Phase 3
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: 2
Group description: Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
Eligibility criteria:
Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

Patient who have received more than 18 months of imatinib therapy
Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
Prior treatment with greater than 400 mg/day imatinib.
Uncontrolled or significant cardiovascular disease.
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Imatinib
Trial phase: Phase 3
ATC code: L01EA01 | L01XE01
SMILES: Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
Eligibility criteria:
Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

Patient who have received more than 18 months of imatinib therapy
Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
Prior treatment with greater than 400 mg/day imatinib.
Uncontrolled or significant cardiovascular disease.
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Normal Saline 100 cc IV daily
Eligibility criteria:
Inclusion Criteria:

Non-pregnant >18 yrs of age
Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
Subjects meeting the clinical prediction rule

Exclusion Criteria:

Subjects with an allergy/intolerance to caspofungin or echinocandin analog
absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
moderate or severe hepatic insufficiency
subjects who are pregnant or lactating
unlikely to survive < 24 hours
subjects who have received systemic antifungal therapy within 10 days prior to study entry
Documented active proven or probable invasive fungal infection upon enrollment
previously enrolled in this study
Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 142
Group description: Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks

Modafinil: 200 mg or 400 mg /daily
Eligibility criteria:
Inclusion Criteria:

Must be between the ages of 18 and 65
Methamphetamine dependent as defined by DSM-IV criteria
Must be in good general heath with a history of methamphetamine use at screening
Must be able to provide written informed consent
If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

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Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Lacosamide 300 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Eligibility criteria:
Inclusion Criteria:

Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
Must be experiencing 2 to 40 seizures per 28-day period
Stable dose of 1 or 2 marketed antiepileptic drugs
Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

Subject has a history of primary generalized or unclassified seizures
Seizure disorder primarily characterized by isolated auras
History of status epilepticus
Seizures that are uncountable due to clustering
Has greater than 5 seizures/day
Subjects taking Benzodiazepines, Phenobarbital or Primidone
Subject has Vagus Nerve Stimulation (VNS)
Significant medical or psychiatric condition
History of alcohol or drug abuse
History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 319
Group description: Lacosamide 400 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Eligibility criteria:
Inclusion Criteria:

Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
Must be experiencing 2 to 40 seizures per 28-day period
Stable dose of 1 or 2 marketed antiepileptic drugs
Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

Subject has a history of primary generalized or unclassified seizures
Seizure disorder primarily characterized by isolated auras
History of status epilepticus
Seizures that are uncountable due to clustering
Has greater than 5 seizures/day
Subjects taking Benzodiazepines, Phenobarbital or Primidone
Subject has Vagus Nerve Stimulation (VNS)
Significant medical or psychiatric condition
History of alcohol or drug abuse
History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
Intervention: Pemetrexed
Trial phase: Phase 2
ATC code: L01BA04
SMILES: Nc1nc(=O)c2c(CCc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)c[nH]c2[nH]1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
Eligibility criteria:
Inclusion Criteria:

Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
Adequate renal, liver and bone marrow function
Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Exclusion Criteria:

Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
Patients with uncontrolled infection
Patients who have received pemetrexed previously
Patients with pleural effusions or ascites
Intervention: Lovenox
Trial phase: Not Applicable
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Lovenox 40mg Subcutaneously (SC) Daily

Lovenox: Lovenox 40mg SC Daily
Eligibility criteria:
Inclusion Criteria:

Male or female > 40 years of age.
Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days.
Pts admitted to the MICU, Regional Heart Units of LV-MHC

Exclusion Criteria:

Surgical primary admission diagnosis
Recent surgery within the past 12 weeks
Planned surgery on the current admission
Pregnancy
Vent-dependent respiratory failure requiring intubation for >24 hours.
Known current DVT or PE prior to enrollment in study.
Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient.
Hx of prior or current lower upper or lower GI bleed.
Platelet count < 100,000 per cubic millimeter
Current or prior anticoagulation within the prior 48 hours, excluding a single dose &lor 24 hour period of prophylactic agent
Bacterial endocarditis.
Hemophilia
Hypersensitivity to aspirin.
Hypersensitivity to Arixtra or Lovenox
Hx of hemorrhagic or ischemic stroke < 3 months prior to enrolling
Hematocrit < 28%.
SBP >200 mmHg or DBP >120 mmHg
Positive for occult blood in stool.
Admission to hospital for > 48 hours prior to randomization
Documented congenital or acquired bleeding disorder
Indwelling intrathecal or epidural catheter
Life expectancy < 30 days
Inability to have a flu assessment post-discharge from the hospital
Intervention: Nitroglycerin
Trial phase: Phase 3
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
Eligibility criteria:
Inclusion Criteria:

Consenting patients of either sex.
Between 18 and 75 years of age.
With a single, chronic, posterior midline anal fissure.
Defined as having anal pain for the 6 weeks prior to Screening.

Exclusion Criteria:

More than one anal fissure.
A fistula-in-ano or anal abscess.
Inflammatory bowel disease.
Fibrotic anal stenosis.
Anal fissure secondary to an underlying condition.
Any anal surgery.
Concomitant medication that may interfere with study evaluation.
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
Eligibility criteria:
Inclusion Criteria:

Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

Single serum total testosterone concentration < 250 ng/dL, or
Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).
Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
Intervention: Raltegravir
Trial phase: Not Applicable
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: 14
Group description: 400 mg twice daily
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)
No change in ART regimen for at least 3 months prior to study entry.
CD4+ cell count >50/mm3 at screening (obtained within 60 days prior to study entry).
Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay
All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single detectable viral load of <50 copies but <200 copies in last 6 months.

Laboratory values obtained within 60 days prior to entry:

Absolute neutrophil count (ANC) >750/mm3
Hemoglobin >9.0 g/dL for female subjects and>10.0 g/dL for male subjects
Platelet count >50,000/mm3
Calculated creatinine clearance (CrCl) >30 mL/min, as estimated by the Cockcroft-Gault equation*
AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
Total bilirubin <2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin <5 x ULN is acceptable.
For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.
Men and women age >18 years.
Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

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.
An opportunistic infection within 60 days prior to entry.
Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.
Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.
Plan to change the background ART within 24 weeks after study entry.
Intervention: Tiotropium
Trial phase: Phase 4
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 238
Group description: 18 mcg tiotropium via HandiHaler® + PRN albuterol
Eligibility criteria:
Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Intervention: Aminolevulinic Acid
Trial phase: Not Applicable
ATC code: L01XD04
SMILES: NCC(=O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.

Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
Eligibility criteria:
DISEASE CHARACTERISTICS:

Actinic keratosis lesion located in any of the following body sites:

Stratum 1*: face and neck, scalp, or upper torso

At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas

Stratum 2*: arms or legs

At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry

PATIENT CHARACTERISTICS:

No porphyria or known hypersensitivity to porphyrins
No known photosensitivity disease
No known sensitivity to any components of aminolevulinic acid topical solution
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
No other concurrent photosensitizer drugs