anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MYCOPHENOLIC ACID
Trial phase: Not Applicable
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days
Eligibility criteria:
Inclusion Criteria:

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.
Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.
Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).
Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).
Patients with tacrolimus- or cyclosporine-induced neurotoxicity.
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period.

Exclusion Criteria:

Multi-organ transplant patients.
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients and nursing mothers.
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment.
Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
Evidence of drug and/or alcohol abuse.
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Intervention: MYCOPHENOLIC ACID
Trial phase: Not Applicable
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.
Eligibility criteria:
Inclusion Criteria:

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
Patients must be more than 30 days post-transplant to be eligible
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period

Exclusion Criteria:

Multi-organ transplant patients
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment
Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)
Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
Evidence of drug and/or alcohol abuse
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Intervention: Dexmedetomidine
Trial phase: Phase 1 | Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I, II or III
Undergoing thoracic surgery on an inpatient basis
Age 18 up to 85 years of age

Exclusion Criteria:

Subject is pregnant and/or lactating
Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
Subject for whom alpha-2 agonists are contraindicated
Subject meets any of the following cardiovascular criteria:
Acute unstable angina (defined during current hospital stay)
Suspicion of acute myocardial infarction.
Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.
Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
Subject is unable to undergo any procedures required by the protocol.
Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
Subject has a known, uncontrolled seizure disorder.
Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
Subject is terminally ill with a life duration expectancy of < 60 days.
Subject has a history of Obstructive Sleep Apnea.
Oxygen saturation is < 90% on room air.
Subject is on beta blocker medication.
Intervention: Dexmedetomidine
Trial phase: Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: infusion 0.3-0.7 dexmedetomidine

Dexmedetomidine: dexmedetomidine infusion titrated to effect
Eligibility criteria:
Inclusion Criteria:

Adults admitted to our surgical ICU who do not have any exclusion criteria
Eligibility for treatment- Development of delirium as defined

Exclusion Criteria:

Acute MI (myocardial infarction),
Trauma <24 hours,
Head injury,
Multiple organ failure,
EF (ejection fraction) < 30%,
History of hypersensitivity to alpha2 agonist,
History of seizures, MAP (mean arterial pressure) <60 mm of Hg,
Dysrhythmias a/with bradycardia (HR (heart rate) <50),
Need for vasopressors,
Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 3
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Eligibility criteria:
Inclusion criteria:

Patients with autoimmune diseases;
receiving immunosuppressive therapy that includes MMF at time of study enrollment;
receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1 month prior to enrollment. Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).

Exclusion criteria:

If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception;
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
Current acute medical intervention or hospitalization;
Presence of a medical condition not related to a GI event at time of visit, which requires immediate medical intervention.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 398
Group description: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Eligibility criteria:
Inclusion Criteria:

Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]

Exclusion Criteria:

Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Intervention: Perampanel
Trial phase: Phase 3
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
Eligibility criteria:
INCLUSION CRITERIA:

Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.
Patients must have been diagnosed with idiopathic PD at > 30 years of age.
Patients must have predictable motor fluctuations of the wearing "OFF" type.
Patients must rate between II-IV on the Hoehn & Yahr scale when in an "OFF" state.
Patients must be taking optimized levodopa therapy.

EXCLUSION CRITERIA:

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.
Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
Intervention: Cycloserine
Trial phase: Not Applicable
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Brief imaginal exposure therapy plus DCS pill
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 18 years of age or older who served in Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) and who have a primary diagnosis (designated by the patient as the most important source of distress of PTSD.
Willingness and ability to comply with the requirements of the study protocol.

Exclusion Criteria:

A lifetime history of:

bipolar disorder
schizophrenia
psychosis
delusional disorders or obsessive-compulsive disorder
organic brain syndrome
cognitive dysfunction that could interfere with capacity to engage in therapy
a history of substance or alcohol dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate services.
Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
Serious medical illness or instability for which hospitalization may be likely within the next year.
Patients with a current or past history of seizures
Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., intra uterine device, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration specifically targeting PTSD is excluded. General supportive therapy initiated > 3 months prior is acceptable.
Patients with seizures or ongoing severe cognitive impairment that compromised mental status.
Patients receiving Isoniazid.
Patients unable to understand study procedures and participate in the informed consent process.
Patients with a history of renal insufficiency (creatinine clearance less than 50 mL/min).
Intervention: Riluzole
Trial phase: Phase 2
ATC code: N07XX02
SMILES: Nc1nc2ccc(OC(F)(F)F)cc2s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
Diagnosed with Bipolar I or II disorder and currently depressed
Tried at least one antidepressant during the current episode of depression
Currently taking either lithium, depakote, or tegretol
Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

Current psychotic symptoms
Women who are pregnant or nursing
Any serious, uncontrolled medical illness
History of liver problems
Current or past blood diseases
Current drug or alcohol abuse
Currently receiving Electroconvulsive Shock Therapy (ECT)
Judged to be at serious suicidal risk
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours
Eligibility criteria:
Inclusion Criteria:

Singleton pregnancy
Cephalic presentation
36 completed weeks of gestation
Intact membranes
Unfavorable cervix (defined as Bishop score < 5)
Indication for induction of labor
Fetal Station less than or equal to -3

Exclusion Criteria:

Clinically significant vaginal bleeding
Evidence of spontaneous labor (3 contractions in 10 minutes)
Contraindication to induction of labor or to use of prostaglandins
Fetal station higher than -3
Intervention: Decitabine
Trial phase: Phase 2 | Phase 3
ATC code: L01BC08
SMILES: Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 20 mg/m^2 intravenous (IV) daily for 5 days
Eligibility criteria:
Inclusion Criteria:

Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
Performance status of 0, 1, or 2
Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal

Exclusion Criteria:

Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
Known to be HIV+
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
No other investigational therapy within the past 14 days
Intervention: Drospirenone
Trial phase: Phase 3
ATC code: G03AA12 | G03AA18 | G03AC10 | G03FA17
SMILES: [H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 554
Group description: Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
Eligibility criteria:
Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use condoms;
Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index >=17 and <=35;
Good physical and mental health;
Willing to give informed consent in writing.

Exclusion Criteria:

Contraindications for contraceptive steroids
In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
Renal insufficiency;
Hepatic dysfunction;
Adrenal insufficiency.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
Clinically relevant abnormal laboratory result at screening as judged by the investigator;
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
Intervention: Decitabine
Trial phase: Phase 2
ATC code: L01BC08
SMILES: Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
Eligibility criteria:
Inclusion Criteria:

Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, granulocyte colony-stimulating factor (GCSF) are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT < 2.5x institutional upper limit of normal.
Signed informed consent.

Exclusion Criteria:

Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Active and uncontrolled infections.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Known ornithine transcarbamylase disorder.
Patients requiring continuous valproic acid treatment for the control of seizure disorders.
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Eligibility criteria:
Inclusion Criteria:

Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
Subjects who were discontinued prior to the end of titration period