anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Raloxifene
Trial phase: Phase 3
ATC code: G03XC01
SMILES: O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12
Sex: Female
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1498
Group description: Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years
Eligibility criteria:
Inclusion Criteria:

Women enrolled in STAR trial at a site participating in Co-STAR
65 years of age or older
Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year
Have not been diagnosed with dementia
Have signed a separate consent document for the Co-STAR Study
Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion Criteria:

Not enrolled in the STAR Trial
Younger than 65 years of age
Diagnosed with dementia
Intervention: Travoprost
Trial phase: Phase 3
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 363
Group description: One drop self-administered in the study eye(s) once daily for 90 days
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.
Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
Patients have to be 18 years-old or older
Able to give signed Informed consent

Adequate end-organ function with laboratory parameters as follows:

Neutrophils: 1.5 x10^9/L or greater
Plts: 100 x10^9/L or greater
Hemoglobin: ≥ 9.0g/dL
Serum Creatinine: ≤ 1.5mg/dL
Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
Measurable or non-measurable disease by RECIST criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
Life expectancy greater than 3 months
Willing and able to comply with the protocol requirement.
Patients must not have any peripheral neuropathy equal or greater than grade 2

Exclusion Criteria:

Chemotherapy within 3 weeks prior to enrollment
Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
Any major surgery within 4 weeks prior to enrollment
Peripheral neuropathy equal to or greater than grade 2
Clinical AIDS or known positive HIV serology
Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction within 3 months
History of stroke within 3 months
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
Pregnant (positive pregnancy test) or lactating
Inability to comply with study and/or follow-up procedures
Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
Intervention: Sildenafil
Trial phase: Phase 4
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Sildenafil citrate 100 mg/day (50+25+25)
Eligibility criteria:
Inclusion Criteria:

Patients with type 2 diabetes mellitus
Patients age 35-75
Metabolic control of diabetes by diet or oral treatment (unmodified in the last 3 months)
Blood pressure <160/100 mmHg, including subjects with controlled hypertension, treated with ACE-inhibitors/sartans, unmodified in the last 3 months

Exclusion Criteria:

Participation in another study with an investigational drug or device
HbA1c >12%
Alterations during ECG stress examination
Current use of nitrate agents
Proliferative retinopathy
Patients with history of cardiovascular and malignant disease
Psychosocial disturbance
Alcohol or drug dependence
Allergy or hypersensitivity to sildenafil or other Phosphodiesterase inhibitors.
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Eligibility criteria:
Inclusion Criteria:

Primary open-angle glaucoma in one eye
Visual acuity 20/80 or better
Intraocular pressure in the study eye ≤ 24 mm Hg
Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

Known allergy to brimonidine tartrate
Uncontrolled systemic disease or infection of the eye
Recent eye surgery or injections in the eye
Female patients who are pregnant, nursing or planning a pregnancy
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
Eligibility criteria:
Inclusion Criteria:

patients recently diagnosed with primary open angle glaucoma or ocular hypertension
Caucasian and African American ethnicities
Male and Female
Age 30 and above

Exclusion Criteria:

A history of ocular medication use within the last 12 months
Inflammatory/ allergic skin diseases or dermatitis
presence of periocular hyperpigmented skin lesions
Systemic pigmentation disorders
Use of systemic drugs that can affect skin pigmentation
Visitation of tanning salons, or use of self tanning products
Pregnancy or patients planning to become pregnant in the near future
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: One drop self administered in the study eye(s) once daily at night for 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
IOP controllable and stable on the study medication alone (both eyes).
Believed to have ocular surface disease (OSD).
Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
Current use of punctual plugs.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Suspected or diagnosed with Sjogrens's syndrome.
Current use of any brand of artificial tears containing BAK.
Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
Current use of contact lenses within 30 days of Visit 1.
Participation in any other investigational study within 30 days prior to Visit 1.
Other protocol-defined exclusion criteria may apply.
Intervention: Betahistine
Trial phase: Phase 2
ATC code: N07CA01
SMILES: CNCCc1ccccn1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Subjects assigned to this arm will receive Betahistine.

Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.
Eligibility criteria:
Inclusion Criteria:

Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder
Patients will be currently treated with antipsychotics

Patients will qualify for entry if they meet the following weight criteria:

The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.

The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.

.

Exclusion Criteria:

Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.
Intervention: Ergocalciferol
Trial phase: Not Applicable
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Vitamin D arm

vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
Eligibility criteria:
Inclusion Criteria:

One or more prescription for quinine at the Madison VA in the last 5 years, or else be a UWHC (U Wisconsin Health Clinics) patient whose UWHC medication list had quinine listed in the last five years
At least 50 years of age, with women being past menopause. This is defined as the woman reporting no periods in the last 12 consecutive months or longer.
Leg cramps listed in medical record,
Ability & willingness to give informed consent,
Stable estimated Glomerular filtration rate (GFR)>35 ml/min for the prior 6 mos,
No change in diuretic therapy in last 3 months,
Stable pattern of two or more cramps per week for past three months,
Ability to complete daily diary entry,
Post-consent: serum 25-OH of 20-45 ng/mL, albumin- corrected calcium <10.3 mg/dL, and urine calcium/creatinine ratio <0.25.

Exclusion Criteria:

Not receiving primary care at Madison VAMC, or at UWHC
Hyperparathyroidism (1°, 2°, or 3°),
Osteomalacia ,
Paget's disease,
Metastatic cancer,
Taking vitamin D 50,000 units capsules,
Serum Ca++ >10.3 mg/dL in subject chart,
Sarcoidosis or tuberculosis, and
Peripheral vascular disease or other condition confounding assessment of cramps.
Intervention: Zoledronic acid
Trial phase: Phase 3
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: Female
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
Eligibility criteria:
Inclusion Criteria:

Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

Poor kidney, eye, liver health
Use of certain therapies for osteoporosis in study CZOL446H2301E1
Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 237
Group description: Mometasone furoate 200 mcg
Eligibility criteria:
Inclusion Criteria:

Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
Must be willing and able to provide informed consent and to participate in all study procedures
Must be in generally good health
Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Use of any investigational drug within 30 days of the first visit
Any nasal surgery or sinus surgery within the previous year
Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
Women who are pregnant or nursing
Women who are not using an acceptable method of birth control
Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
Patients with Arrythmia
Patients with know history of alcohol and drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
Use of medications that could affect the study results
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 333
Group description: Mometasone furoate nasal spray 200 mcg QD (once per day)
Eligibility criteria:
Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Intervention: Loratadine
Trial phase: Phase 4
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
Eligibility criteria:
Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration