anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Triamcinolone
Trial phase: Phase 3
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Eligibility criteria:
Inclusion Criteria:

Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.
Intervention: Triamcinolone
Trial phase: Phase 3
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 138
Group description: Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Eligibility criteria:
Inclusion Criteria:

Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.
Intervention: Risedronate sodium
Trial phase: Phase 3
SMILES: O=P([O-])(O)C(O)(Cc1cccnc1)P(=O)(O)O.[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 94
Group description: risedronate tablet, once a day for one year then for two years open label risedronate once a day
Eligibility criteria:
Inclusion Criteria:

OI diagnosis
increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

Exclusion Criteria:

Any bisphosphonate use within one year of enrollment
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Eligibility criteria:
Inclusion Criteria:

Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion Criteria:

Patient is > 65 years of age
Patient has been diagnosed with Type 1 or Type 2 diabetes
Patient is actively smoking on a daily basis
Intervention: Citalopram
Trial phase: Phase 3
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 155
Group description: Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
Eligibility criteria:
Inclusion Criteria:

Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
Patient's current depressive episode must be at least 12 weeks in duration
Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.

Exclusion Criteria:

Patients who currently meet DSM-IV criteria for:

attention deficit-hyperactivity disorder
obsessive-compulsive disorder
posttraumatic stress disorder
bipolar disorder
pervasive developmental disorder
mental retardation
conduct disorder
oppositional defiant disorder
Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
Intervention: Nitisinone
Trial phase: Phase 2
ATC code: A16AX04
SMILES: O=C1CCCC(=O)C1C(=O)c1ccc(C(F)(F)F)cc1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects received nitisinone 2 mg orally, once daily.
Eligibility criteria:
INCLUSION CRITERIA:
Age 30-80 years, either gender
Diagnosis of alkaptonuria based upon urinary HGA excretion greater than 0.4 g/24h
At least one hip joint remaining
Some evidence of hip involvement, e.g., pain or decreased range of motion
Ability to travel to the NIH Clinical Research Center for admissions
Ability to consent
Availability of local medical follow-up

EXCLUSION CRITERIA:

Age less than 30 or greater than 80
Non-alkaptonuria causes of ochronosis
Bilateral hip joint replacement
Keratopathy
Contact lenses
Uncontrolled glaucoma
History of myocardial infarction
History of emphysema or pulmonary insufficiency (Forced vital capacity less than 70%)
Psychiatric illness or neurological disease that interferes with compliance or communication with health care personnel
Current malignancy
Open skin lesions
Dietary habits or use of homeopathic therapies that interfere with tyrosine catabolism. The diet must be reasonably balanced, as determined by a dietician.
Uncontrolled hypertension (blood pressure greater than 180 systolic or greater than 95 diastolic)
History of extreme alcohol abuse or sever liver disease
Liver greater than 3 cm below the right costal margin
Electrocardiogram changes indicative of myocardial infarction, arrhythmia, tachycardia, bradycardia, left bundle branch block
Chest radiographic abnormalities, including an infiltrate, mass, congestive heart failure, embolism, atelectasis
Serum postassium less than 3. 0 mEq/L
Serum creatinine greater than 2.0 mg/dL
Serum glutamic-pyruvic transaminase (SGPT) greater than 41 U/L or Serum glutamic-oxaloacetic transaminase (SGOT) greater than 34 U/L
Creatine kinase (CK) greater than 500 U/L
Hemoglobin less than 10.0 g/dL
Platelets less than 100 k/mm(3)
White blood cells (WBCs) less than 3.0 k/microL
Free thyroxine (T4) greater than 15 microg/dL
T4 less than 4 microg/dL
Erythrocyte sedimentation rate (ESR) greater than 100 mm/h
Plasma tyrosine greater than 150 microM
Intervention: Nevirapine
Trial phase: Phase 1
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Intravenous placebo for PRO 140

PRO 140: Monoclonal antibody to CCR5
Eligibility criteria:
Inclusion Criteria:

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140
Intervention: Nevirapine
Trial phase: Phase 1
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 0.1 mg/kg PRO 140 by intravenous infusion

PRO 140: Monoclonal antibody to CCR5
Eligibility criteria:
Inclusion Criteria:

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140
Intervention: Nevirapine
Trial phase: Phase 1
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 0.5 mg/kg PRO 140 by intravenous infusion

PRO 140: Monoclonal antibody to CCR5
Eligibility criteria:
Inclusion Criteria:

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140
Intervention: Nevirapine
Trial phase: Phase 1
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 2.0 mg/kg PRO 140 by intravenous infusion

PRO 140: Monoclonal antibody to CCR5
Eligibility criteria:
Inclusion Criteria:

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140
Intervention: Nevirapine
Trial phase: Phase 1
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 5.0 mg/kg PRO 140 by intravenous infusion

PRO 140: Monoclonal antibody to CCR5
Eligibility criteria:
Inclusion Criteria:

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140
Intervention: Denagliptin
Trial phase: Phase 2
SMILES: N#C[C@@H]1C[C@H](F)CN1C(=O)[C@@H](N)C(c1ccc(F)cc1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
Eligibility criteria:
Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Intervention: Denagliptin
Trial phase: Phase 2
SMILES: N#C[C@@H]1C[C@H](F)CN1C(=O)[C@@H](N)C(c1ccc(F)cc1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
Eligibility criteria:
Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Intervention: Denagliptin
Trial phase: Phase 2
SMILES: N#C[C@@H]1C[C@H](F)CN1C(=O)[C@@H](N)C(c1ccc(F)cc1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
Eligibility criteria:
Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Intervention: Denagliptin
Trial phase: Phase 2
SMILES: N#C[C@@H]1C[C@H](F)CN1C(=O)[C@@H](N)C(c1ccc(F)cc1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Eligibility criteria:
Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Intervention: Denagliptin
Trial phase: Phase 2
SMILES: N#C[C@@H]1C[C@H](F)CN1C(=O)[C@@H](N)C(c1ccc(F)cc1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Eligibility criteria:
Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Intervention: Cilengitide
Trial phase: Phase 2
SMILES: CC(C)[C@H]1C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](Cc2ccccc2)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cilengitide: Given IV

therapeutic conventional surgery: Undergo tumor resection

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed intracranial glioblastoma multiforme (GBM)

Original diagnosis of low-grade glioma with subsequent histological confirmation of GBM allowed

Recurrent disease

Failed prior radiotherapy
Must require a surgical procedure (gross total or near gross total resection) for tumor removal
Performance status - Karnofsky 60-100%
White Blood Count (WBC) ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL (transfusion allowed)
Serum glutamic oxaloacetic transaminase (SGOT) < 2 times upper limit of normal (ULN)
Bilirubin < 2 times ULN
Creatinine < 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for ≥ 2 weeks after study participation (for female patients) or for 3 months after study participation (for male patients)
No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No active infection
No other significant uncontrolled medical illness that would preclude study participation
At least 3 weeks since prior interferon
No prior cilengitide
No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or thalidomide)
No concurrent anticancer immunotherapy
No concurrent routine prophylactic filgrastim (G-CSF)
At least 2 weeks since prior vincristine
At least 3 weeks since prior procarbazine
At least 6 weeks since prior nitrosoureas
No concurrent anticancer chemotherapy
At least 3 weeks since prior tamoxifen
No concurrent anticancer hormonal therapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy
No concurrent anticancer radiotherapy
Recovered from all prior therapies

No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2 relapses)

For patients who received prior therapy for low-grade glioma, a subsequent surgical diagnosis of high-grade glioma is considered the first relapse
At least 4 weeks since prior investigational agents
At least 4 weeks since prior cytotoxic therapy
At least 3 weeks since other prior non-cytotoxic therapy (e.g., isotretinoin), except radiosensitizers
No other concurrent anticancer therapy
No other concurrent investigational agents
Intervention: Tranexamic acid
Trial phase: Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 723
Group description: Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Eligibility criteria:
Inclusion Criteria:

Women with menorrhagia
18-49 years of age
Regularly occuring menstrual periods

Exclusion Criteria:

History or presence of clinically significant disease or abnormalities that might confound the study
History of bilateral oophorectomy or hysterectomy
Intervention: Montelukast
Trial phase: Phase 2 | Phase 3
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 62
Group description: Montelukast tablets or granules

Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules.
Eligibility criteria:
Inclusion Criteria:

Physician-diagnosed wheezing illness

Exclusion Criteria:

Asthma
Prematurity
Known intolerance to montelukast
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Intravenous ketorolac and oral placebo
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of any form of SCD, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-ß˖ or ß°-thalassemia
Currently experiencing an acute painful episode (vaso-occlusive crisis), defined as acute pain in the extremities, back, abdomen, or chest that has lasted at least 4 hours and is presumed to be due to SCD, with no other identified cause
Onset of severe pain in its current location(s) must have occurred within 72 hours of study entry
Intensity of pain must be great enough to necessitate hospitalization for opioid analgesia (e.g., failure of home and outpatient therapy)
Ability to comprehend and use patient-controlled analgesia (PCA)
Score of 6 or greater on the baseline pain scale

Exclusion Criteria:

Temperature greater than or equal to 38.5ºC at the time of study entry or in the preceding 12 hours
Has a new lobar pulmonary infiltrate or a diagnosis of acute chest syndrome (i.e., a new lobar pulmonary infiltrate and two or more of the following: temperature greater than 38ºC, tachypnea, dyspnea, intercostal or supraclavicular retractions, nasal flaring, chest wall pain, and an oxygen saturation of less than 90% in room air by pulse oximetry)
Diagnosis of acute splenic or hepatic sequestration crisis (i.e., liver or spleen enlarged from steady-state size and Hgb level decreased 2 g/dL or more from steady-state value)
Currently experiencing priapism
Pain caused by suspected or confirmed hepatobiliary disease (e.g., cholecystitis or cholelithiasis)
Chronic pain caused by suspected or confirmed aseptic or avascular necrosis of the femoral or humeral heads
Chronic pain syndrome characterized by opioid tolerance and defined by hospitalization for at least 30 days for the management of pain in a 1 year period prior to study entry
Current participation (last transfusion given within the 2 months prior to study entry) in a program of chronic transfusions for the management of SCD; the use of hydroxyurea alone is permitted
Allergy or history of anaphylactoid reactions to aspirin or other NSAIDs
Kidney dysfunction (i.e., serum creatinine concentration greater than 1.5 times the upper limit of normal for age)
History of gastrointestinal bleeding or ulceration requiring medical therapy
Concomitant bleeding disorder (e.g., von Willebrand disease, hemophilia, or a qualitative platelet defect)
Any other medical condition that would make it unsafe to receive NSAIDs, as determined by the study physician
PCA not preferred
Use of ketorolac in the 30 days prior to study entry
Use of scheduled (e.g., "around the clock") opioid analgesics in the 5 days before the onset of current acute painful crisis
Pregnant