anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sulindac
Trial phase: Phase 2
ATC code: M01AB02
SMILES: CC1=C(CC(=O)O)c2cc(F)ccc2/C1=C\c1ccc([S+](C)[O-])cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Patients receive oral sulindac twice daily for 6 months.
Eligibility criteria:
Inclusion Criteria:

Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:

No prior lung cancer
Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
Tissue blocks, blood, and sputum samples available for research purposes
No carcinoma in situ
ECOG performance status 0-1
Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
Room air oxygen saturation ≥ 90%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Negative chest x-ray
Negative electrocardiogram

No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer

Treatment must have been completed > 6 months ago
No prior gastrointestinal ulceration, bleeding, or perforation

No uncontrolled illness including, but not limited to, any of the following:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Myocardial infarction within the past 6 months
Chronic renal disease
Chronic liver disease
Difficult to control hypertension
Psychiatric illness or social situations that would limit study compliance
No known HIV positivity
No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
No known sensitivity to yellow dye FD&C Yellow #5
No continuous or intermittent supplemental oxygen
At least 6 months since prior participation in another chemoprevention trial
At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
No prior pneumonectomy
No prior solid organ transplantation
No other concurrent investigational agents

No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention

Maximum of 1 aspirin (81 mg) per day allowed

No concurrent use of any of the following:

Methotrexate
Corticosteroids

Antiplatelet agents:

Warfarin
Ticlopidine
Clopidogrel bisulfate
Aspirin
Abciximab
Dipyridamole
Eptifibatide
Tirofiban hydrochloride
Lithium carbonate
Cyclosporine
Hydralazine
Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed)
Angiotensin receptor blockers
Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Lansoprazole 30 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Vocal skills necessary to complete test procedures reliably.
Voice complaints and/or other symptoms suggestive of reflux laryngitis
Signed informed consent
At least 18 years of age.
Complete medical history and physical examination within 30 days prior to initiation of the study drug.
Laryngoscopy documenting laryngeal pathology compatible with moderate to severe reflux laryngitis (> grade 3 arytenoid erythema) within 30 days of initiation of the study drug.
Gastroesophageal reflux confirmed by 24-hour (a minimum of 16 hours required for inclusion) pH impedance monitor.
Ambulatory outpatient status.
If female, a negative pregnancy test at the screening visit or either: i) surgically sterilized (bilateral tubal ligation or hysterectomy), or ii) at least 1 year post-menopausal, or iii) using acceptable methods of contraception in the presence of childbearing potential.

Exclusion Criteria:

Concurrent laryngeal disease, if such disease or its treatment would interfere with evaluation of study results. For example, patients with mass lesions such as laryngeal cysts or laryngeal carcinoma will be excluded. Patients with acute laryngeal infections or acute laryngeal allergies will be excluded until these conditions have been resolved; but they may be considered for inclusion thereafter.
Any upper gastroenterological or esophageal surgery except simple over-sewing of a perforated ulcer.
Active substance abuse.
Tobacco use.
Known hypersensitivity or allergy to any protein pump inhibitor.
ALT (SGPT) or AST (SGOT) greater than 2 times the upper limit of normal.
Renal impairment (serum creatinine > 2.0 mg/dl).
Any clinically significant, unstable medical condition.
Use of any proton pump inhibitor within 7 days prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy, or use of H2 receptor antagonist during the 48 hours prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy.
Use of an investigational drug or participation in an investigational study, within 30 days prior to starting study drug.
Previous participation in this study.
Pregnant women.
Women breast feeding infants.
Inability or refusal to follow directions.
Open label sub-study has same inclusion and exclusion criteria, with exception that subjects should have: 1) Clinical diagnosis of non-acid reflux, with less than 5 episodes of proximal acid reflux, and 2) Symptoms and signs consistent with gastroesophageal reflux.
Intervention: GLUTAMIC ACID
Trial phase: Phase 3
ATC code: A09AB01
SMILES: NC(CCC(=O)O)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
Eligibility criteria:
INCLUSION CRITERIA:

Patients ≥ 3 and < 21 years of age at the time of study registration.
Patients newly diagnosed with Wilm's tumor and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen.
Patients newly diagnosed with rhabdomyosarcoma and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen.
Patients newly diagnosed with ALL and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy.
Patients newly diagnosed with Non- Hodgkins Lymphoma (NHL) and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy.
Patients with no underlying neuromuscular disease or peripheral neuropathy

EXCLUSION CRITERIA:

Abnormal baseline peripheral neurologic exam (i.e. or peripheral neuropathy)
Patients with:
seizure disorders
primary intracranial malignancy
family history of Charcot Marie Tooth Disease
a recent history of GuillianBarré26
Patients receiving concomitant itraconazole are at risk for increased vincristine toxicity and therefore are ineligible.
Patients who are regularly using laxatives or stool softeners for constipation at the time of enrollment are not eligible to participate in the study. Likewise, since prevention of neuro-constipation will be evaluated, patients with an ongoing history of constipation that has required frequent use of laxatives or stool softeners should not be enrolled.
Patients should not be scheduled to receive laxatives or stool softeners prophylactically to prevent constipation, as the prevention of neuro-constipation will be evaluated in this study; however, when patients show signs of developing constipation while on chemotherapy, as determined by the treating physician, they may be treated with laxatives or stool softeners at the clinician's discretion. Use of laxatives or stool softeners will be documented on the concomitant medication log.
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Eligibility criteria:
Inclusion Criteria:

Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Exclusion Criteria:

Is pregnant or is considering becoming pregnant during the course of the study
Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
Intervention: Sandostatine
Trial phase: Phase 3
SMILES: CC(=O)O.CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Eligibility criteria:
Inclusion Criteria:

Written voluntary informed consent.
Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
Baseline (mean of 3 samples) GH level > 2 µg/L.
Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Sandostatine
Trial phase: Phase 3
SMILES: CC(=O)O.CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Eligibility criteria:
Inclusion Criteria:

Written voluntary informed consent.
Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
Baseline (mean of 3 samples) GH level > 2 µg/L.
Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.

Other protocol-defined inclusion/exclusion criteria applied to the study.
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
Healthy volunteers: No
Participants at risk: 10
Group description: Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
Eligibility criteria:
Inclusion criteria:

T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing.

Exclusion criteria:

Must not have any other major illness other than diabetes
Intervention: Growth hormone
Trial phase: Phase 4
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
Eligibility criteria:
Inclusion Criteria:

isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in response to arginine-insulin stimulation with cortisol responses and thyroid function tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency (growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

Exclusion Criteria:

Taking medications other than the appropriate hormonal replacement(L-thyroxine, cortisol, estrogen or testosterone, DDAVP)
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3970
Group description: Celecoxib open-label per United States Package Insert (US PI) recommended dosing
Eligibility criteria:
Inclusion Criteria:

Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria:

GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for current cocaine abuse
Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at least $70 per week on cocaine
Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or exceed those administered in the study
Age 21-45
Able to give informed consent, and comply with study procedures

Exclusion Criteria:

Current seizure disorder, heart disease or psychiatric disorders (other than cocaine dependence)
Dependence on substances other than cocaine or nicotine
Request for drug treatment
Judged to be noncompliant with study protocol
Current use of any medication that has the potential to interact with aripiprazole (i.e., seizure medications, anti-fungal medications, cardiac medications, or medication that produces drowsiness)
Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
Current parole or probation
History of significant violent or suicidal behavior
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: Patients treated with N-acetylcysteine
Eligibility criteria:
Inclusion Criteria:

All patients transferred to or born at C.S. Mott Children's Hospital between 0 and 3-months-old undergoing ASO for d-TGA or anatomic variants (including double-outlet right ventricle with transposition physiology).

Exclusion Criteria:

Less than 36-weeks post-conceptional age at the time of enrollment
Birth weight less than 1800 grams;
Evidence of significant renal, hepatic, or neurological dysfunction
Additional significant cardiac lesions other than patent ductus arteriosus, isolated ventricular septal defect, simple coarctation, and/or atrial septal defect
Preoperative extracorporeal membrane oxygenation (ECMO).
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: marijuana cigarette (0%, 1.8%, or 3.6% THC)

marijuana cigarette
Eligibility criteria:
Inclusion Criteria:

Current blunt marijuana use (minimum of twice/week) drug screen
21-45 years of age
Practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

Exclusion Criteria:

Current, repeated illicit drug use(excluding marijuana)
Heavy cigarette use (> 10 cigarettes/day)
Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)
Significant adverse reaction to marijuana
Current parole or probation
Pregnancy or current lactation
History of significant violent behavior
Major current Axis I psychopathology(e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia)
History of heart disease
Current use of any over-the-counter or prescription
Intervention: Pimozide
Trial phase: Phase 2
ATC code: N05AG02
SMILES: O=c1[nH]c2ccccc2n1C1CCN(CCCC(c2ccc(F)cc2)c2ccc(F)cc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Half of the subjects are randomized to the active drug.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder.
A minimum Brief Psychiatric Rating Scale (BPRS) score of 35 and a BPRS psychotic symptom cluster score of at least 8.
Currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
Able to give informed consent.

Exclusion Criteria:

A history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
History of Neuroleptic Malignant Syndrome.
Current substance abuse determined by urine toxicology.
Cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, Wolff-Parkinson-White Syndrome, first, second, third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (EKG). Study doctors will examine the EKGs and consult with an internist/cardiologist as needed.
on EKG: QTc > 450 ms.
Current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged QTc.
Current use of antipsychotics other than clozapine.
Current use of sertraline.
IQ level below 70.
At high risk for suicidal/homicidal behavior.
Pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
Non-English speaking.
Intervention: Atorvastatin
Trial phase: Not Applicable
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: 80
Group description: Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
Eligibility criteria:
Inclusion Criteria:

Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy, lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or extrapleural pneumonectomy) with or without chest wall resection or limited resection
Patients with regular cardiac rhythm
Patients able to take oral capsules
Patients capable of providing written, informed consent
Patients without known hepatic or kidney disease

Exclusion Criteria:

Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
Hypersensitivity to atorvastatin
Chronic atrial fibrillation
Patients already taking class Ic or III antiarrhythmic drugs
Known pregnancy a urine pregnancy test will be given to women of childbearing age
Known history of active hepatic disease or known hepatic insufficiency
Known history of active kidney disease or insufficiency