anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients must be aged 18 to less than 75 years.
Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
All female patients must test negative for pregnancy.
Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.

Exclusion Criteria:

Is investigator site personnel directly affiliated with this study or their immediate families.
Is a Lilly employee.
Has previously completed or withdrawn from this study or any other study investigating olanzapine.
Is pregnant or nursing.
Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.
Intervention: Alprostadil
Trial phase: Phase 3
ATC code: C01EA01 | G04BE01
SMILES: CCCCCC(O)C=CC1C(O)CC(=O)C1CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Alprostadil 60 mcg/day i.v. for 15 days
Eligibility criteria:
Inclusion Criteria:

Male and female subjects older than 50 years of age.
Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning geographic atrophy in one eye
Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts

Exclusion Criteria:

Dry AMD AREDS category 3 or 4 in both eyes
Wet AMD in at least one eye
Detachment of the pigmentary epithelium
Glaucoma
Diabetic retinopathy
Medical history of retinal vein occlusion
Uveitis
Cataract surgery during the study
High myopia (< -6 dpt) with pathological findings of the retina
Medical history of any opthalmic surgery with complications
Medical history of cataract surgery without complications within the last 12 weeks
Medical history of vitrectomy
AREDS medication within the last 2 days
Opthalmologic dietary supplements within the last 2 days
Medical history of retinal hemorrhage
Cardiac failure (NYHA grade II or higher)
Inadequately controlled coronary heart disease or cardiac arrhythmia
Subject has a medical history and/or suspicion of pulmonary edema or pulmonary infiltration
Subject has a peripheral edema
Myocardial infarction within 6 months prior to enrollment
Subject has renal insufficiency, compensated retention (creatinine > 1,5 mg/dL)
Subject has known existing malignant disease
Severe chronic obstructive pulmonary disease
Subject has a venoocclusive lung disease
Known hepatic disease
Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
Subject has upper grade cardiac valvular disorders
Pregnancy or lactation period
Known hypersensitivity to PGE1 or to any component of the trial medication
Subject has a history of chronic alcohol or drug abuse within the past 2 years
Subject has known lactose intolerance
Poor general state of health or other criteria
Subject has other serious illness
Laboratory values outside the normal range unless considered not clinically relevant by the investigator
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.

Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Be female, aged 18 to 49 years, inclusive
Have moderate to severe pelvic pain due to endometriosis
Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
Have regular menstrual cycle
Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
Have had surgery for endometriosis within the last month
Have had a hysterectomy or bilateral oophorectomy
Are using systemic steroids on a chronic or regular basis within 3 months
Have uterine fibroids ≥ 3 cm in diameter
Have pelvic pain that is not caused by endometriosis
Have unstable medical condition or chronic disease
Have been pregnant within the last six months
Currently breast feeding
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.

Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Be female, aged 18 to 49 years, inclusive
Have moderate to severe pelvic pain due to endometriosis
Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
Have regular menstrual cycle
Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
Have had surgery for endometriosis within the last month
Have had a hysterectomy or bilateral oophorectomy
Are using systemic steroids on a chronic or regular basis within 3 months
Have uterine fibroids ≥ 3 cm in diameter
Have pelvic pain that is not caused by endometriosis
Have unstable medical condition or chronic disease
Have been pregnant within the last six months
Currently breast feeding
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 439
Group description: Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Eligibility criteria:
Inclusion Criteria:

Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria:

Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 783
Group description: 2 week run-in period
Eligibility criteria:
Inclusion Criteria:

Clinical indication for coronary angiography
Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation
Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation
LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

Exclusion Criteria:

Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study
Intervention: Atorvastatin
Trial phase: Phase 3
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: 795
Group description: 2 week run-in period
Eligibility criteria:
Inclusion Criteria:

Clinical indication for coronary angiography
Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation
Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation
LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

Exclusion Criteria:

Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study
Intervention: Atorvastatin
Trial phase: Phase 3
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: 689
Group description: 2 year core study
Eligibility criteria:
Inclusion Criteria:

Clinical indication for coronary angiography
Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation
Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation
LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

Exclusion Criteria:

Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Eligibility criteria:
Inclusion Criteria:

Completion of study A9451162 (NCT00603473)

Exclusion Criteria:

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 67
Group description: Subjects receive intra-op Ropivicaine 0.5% injection per protocol
Eligibility criteria:
Inclusion Criteria:

The subject is scheduled to undergo elective total knee replacement at Duke University Hospital.
The subject has signed the written consent form.

Exclusion Criteria:

Known allergy to ropivacaine or hydromorphone.
Known history of narcotic abuse or alcohol abuse.
Known history of chronic pain.
Known diagnosis of peripheral neuropathy or complex regional pain syndrome.
Significant impediment to physical therapy participation.
The surgery is a revision case.
Patient is undergoing bilateral Total Knee Replacement.
Intervention: Phenoxybenzamine
Trial phase: Not Applicable
ATC code: C04AX02
SMILES: CC(COc1ccccc1)N(CCCl)Cc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Treatment Group

Phenoxybenzamine: Use of Phenoxybenzamine:

Loading dose given at the time of going on CPB:

For patients with obstructing lesions on systemic side:

0.25 mg/kg dose in the bypass circuit
None intravenous

For patients without obstructing left sided lesions:

0.5 mg/kg in the bypass circuit
0.5 mg/kg I.V. at cannulation

Maintenance dose given in the post-operative period:

0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours
0.3 mg/kg P.O. every 8 hours for next 24 hours
0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop
Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group
Eligibility criteria:
Inclusion Criteria:

Patients

The following patients are candidates for receiving PBZ for HFLPP. These include:

All patients under 16 kg.
Those patients between 16-18 kg whose pre bypass hemoglobin is <16 g/dl
All patients are less than 18 years of age

Exclusion Criteria:

Those with bloodless prime in Cardiopulmonary bypass circuit
Age > 18years
Wt. >16 kg
Intervention: Linagliptin
Trial phase: Phase 3
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 336
Group description: Patients randomized to receive treatment with Linagliptin 5mg
Eligibility criteria:
Inclusion criteria:

Male or female patients with type 2 diabetes and insufficient glycaemic control.
Age 18 or over and not older than 80 years

Exclusion criteria:

Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
Intervention: Leuprolide Acetate
Trial phase: Phase 4
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation
Eligibility criteria:
Inclusion Criteria:

Infertility
Surgical diagnosis of endometriosis
Normal ovarian reserve testing
Regular menses

Exclusion Criteria:

Irregular menses
Undiagnosed abnormal uterine bleeding
Pregnancy
Prior adverse reaction to any GnRH agonist
Ovarian cystic or solid mass > 3cm in mean diameter at study entry
Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry
Current hepatic, renal, hematologic or psychiatric disorder
Intervention: Leuprolide Acetate
Trial phase: Phase 4
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
Eligibility criteria:
Inclusion Criteria:

Infertility
Surgical diagnosis of endometriosis
Normal ovarian reserve testing
Regular menses

Exclusion Criteria:

Irregular menses
Undiagnosed abnormal uterine bleeding
Pregnancy
Prior adverse reaction to any GnRH agonist
Ovarian cystic or solid mass > 3cm in mean diameter at study entry
Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry
Current hepatic, renal, hematologic or psychiatric disorder
Intervention: Bupropion
Trial phase: Phase 2 | Phase 3
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Participants will receive 150MG Bupropion nightly.
Eligibility criteria:
Inclusion Criteria:

clinical diagnosis of Restless Legs Syndrome
Severity Scale score 15 or higher

Exclusion Criteria:

History of seizures
History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
Suicidal thoughts/ideations
Inability to return for follow up appointments at 3 and 6 weeks
Lack of access to telephone
Eating disorder
Age less than 18
Pregnancy
Unwillingness or inability to discontinue any RLS medications
Intervention: Ketorolac
Trial phase: Phase 2
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: ketorolac 2 mg

ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I, II, III
> Age 18
Primary unilateral total hip arthroplasty under spinal anesthesia

Exclusion Criteria:

Known allergy to study medication
Weight > 300 pounds
Obstructive sleep apnea
Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia
Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure
Patients routinely taking narcotic pain medications for pain other than their primary hip pain
Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures
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 | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Eligibility criteria:
Inclusion Criteria:

Current HAM-D score of ≥ 20
Patients with severe asthma (defined as asthma requiring three or more course of oral corticosteroids in the past year).
No changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past week
Needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12 months.
Both male and female
English- or Spanish-speaking

Exclusion Criteria:

Current substance or alcohol abuse/dependence
MDD with psychotic features (delusions, hallucinations, disorganized thought processes)
Bipolar disorder
Schizophrenia or schizoaffective disorder
Substance-induced mood disorder and mood disorder secondary to a general medical condition
Mental retardation or other severe cognitive impairment
Prison or jail inmates
Pregnant or nursing women or women of childbearing age who will not use The University of Texas Southwestern Medical Center - Institutional Review Board (UTSW IRB) approved methods of birth control or abstinence during the study
Treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants
Current antipsychotic or antidepressant therapy or psychotherapy
Initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics)