anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Avanafil
Trial phase: Phase 3
ATC code: G04BE10
SMILES: COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Eligibility criteria:
Inclusion Criteria:

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Have documented diabetes (type 1 or type 2);
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
Androgen replacement therapy that has not been stable for at least 3 month;
Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
ED as a result of spinal cord injury or radical prostatectomy;
Untreated hypogonadism or low serum total testosterone
History of or predisposition to priapism;
Any penile implant;
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
Uncontrolled diabetes;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
Significant cardiovascular disease;
Abnormal ECG;
Hepatic or renal impairment;
Positive STD screen;
Clinically evident penile lesions, abrasions, or anatomical deformities;
Urinary tract or bladder infection;
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
Participation in another investigational study within 30 days of screening or at any time during this study;
Previous participation in any other investigational study of avanafil;
History or current drug, alcohol, or substance abuse;
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
Intervention: Bimatoprost
Trial phase: Phase 1 | Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma
Females of non-childbearing potential
Subject requires IOP-lowering therapy in both eyes
IOP ≥ 22 mm Hg and ≤ 34 mm Hg
Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

Uncontrolled systemic disease
Active ocular disease
Alteration of existing chronic systemic medications
Known allergy or sensitivity to the study medications
Ophthalmic corticosteroids
Visual field loss which in the opinion of the investigator is functionally significant
History of ocular laser, intraocular surgery, or refractive surgery
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
Eligibility criteria:
Inclusion Criteria:

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Men or women 18 years and older.
Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and <180 mmHg at Visit 5 (randomization).

Exclusion Criteria:

Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of Visit 1.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg).
Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
History or evidence of a secondary form of hypertension.
Intervention: Carnosine
Trial phase: Phase 2
SMILES: NCCC(=O)N[C@@H](Cc1cnc[nH]1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

Persian Gulf waters and adjacent land areas,
Other global locations, or,
U.S. only. 1990-1991 enlistment status:
Active duty
National Guard
Reserves

Exclusion Criteria:

HIV/AIDS
Pregnant Women
Active Duty Military Personnel
Children
Incarceration
Intervention: Nifedipine
Trial phase: Phase 2
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period.
Eligibility criteria:
Inclusion Criteria:

Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion Criteria:

Required peritoneal dialysis or haemodialysis.
Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.
Intervention: Nifedipine
Trial phase: Not Applicable
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 301
Group description: Participants randomized to this group will receive the medication nifedipine orally.

Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
Eligibility criteria:
Inclusion Criteria:

Pregnancies with intact membranes in confirmed preterm labor;
20 - 32 weeks' gestation;
Cervical dilatation 0 - 3cm versus 4 - 6cm;
No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND
Able and willing to consent to the study protocol.

Exclusion Criteria:

Failure to meet admission criteria;
Known serious fetal malformations;
Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);
Allergic to magnesium, antiprostaglandin or calcium channel antagonist;
Refusal or inability to consent to the study
Intervention: Indomethacin
Trial phase: Not Applicable
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 301
Group description: Participants randomized to this arm will receive the medication indomethacin per rectum and orally.

Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
Eligibility criteria:
Inclusion Criteria:

Pregnancies with intact membranes in confirmed preterm labor;
20 - 32 weeks' gestation;
Cervical dilatation 0 - 3cm versus 4 - 6cm;
No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND
Able and willing to consent to the study protocol.

Exclusion Criteria:

Failure to meet admission criteria;
Known serious fetal malformations;
Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);
Allergic to magnesium, antiprostaglandin or calcium channel antagonist;
Refusal or inability to consent to the study
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: 10 cc of Normal Saline (10mg) as placebo injected in paracervical region
Eligibility criteria:
Inclusion Criteria:

Women eligible and scheduled for office hysteroscopic placement of essure devices

Exclusion Criteria:

Planned secondary procedures
Lidocaine allergy
Repeat procedures
Intervention: Lactulose
Trial phase: Phase 2
ATC code: A06AD11 | A06AD61
SMILES: OCC1OC(OC2C(CO)OC(O)(CO)C2O)C(O)C(O)C1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 3 months of Lactulose therapy based on pt. weight
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy

Exclusion Criteria:

patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
patients with known hearing or vision difficulties.
those patients who do not speak English will be excluded.
Intervention: Dorzolamide Hydrochloride
Trial phase: Phase 4
SMILES: CCNC1CC(C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Eligibility criteria:
Inclusion Criteria:

Age: 30 years or older.
Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria:

History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Intervention: Nalmefene
Trial phase: Phase 3
ATC code: N07BB05
SMILES: C=C1CC[C@@]2(O)[C@H]3Cc4ccc(O)c5c4[C@@]2(CCN3CC2CC2)[C@H]1O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 501
Group description: as-needed use, tablets, orally, 52 weeks
Eligibility criteria:
Inclusion Criteria:

In- and outpatients who:

had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
had had ≥6 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

had a severe psychiatric disorder or an antisocial personality disorder
had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
had a history of delirium tremens or alcohol withdrawal seizures
reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
Eligibility criteria:
Inclusion criteria:

Men and women, 18 to 64 years of age (inclusive) with International Headache Society (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV primary insomnia (sleep onset/sleep maintenance).
Migraine frequency is 4-12 times per month, with a maximum of 20 days with headache per month, for 1 month or longer prior to screening.
A usual, estimated total sleep time of 6½ hours per night or less, for 1 month or longer prior to screening, due to problems falling asleep, waking up during the night, or waking up early.

Exclusion criteria:

Abortive migraine treatment with schedule II-III opioids.
Use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month.
Preventive migraine treatment with tricyclics or anticonvulsants.
Treatment of insomnia with non-prescription medications, such as diphenhydramine, melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates, benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.
Intervention: Simeprevir
Trial phase: Phase 2
ATC code: G01AE10 | J05AP05
SMILES: COc1ccc2c(OC3CC4C(=O)NC5(C(=O)NS(=O)(=O)C6CC6)CC5C=CCCCCN(C)C(=O)C4C3)cc(-c3nc(C(C)C)cs3)nc2c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
Participants who have never received treatment for their HCV infection
Participants with either no cirrhosis or up to Child Pugh A liver disease
Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening

Exclusion Criteria:

Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
Participants with diagnosed or suspected hepatocellular carcinoma
Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
Intervention: Nalmefene
Trial phase: Phase 3
ATC code: N07BB05
SMILES: C=C1CC[C@@]2(O)[C@H]3Cc4ccc(O)c5c4[C@@]2(CCN3CC2CC2)[C@H]1O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 341
Group description: as-needed use, tablets, orally, 6 months
Eligibility criteria:
Inclusion Criteria:

In- and outpatients who:

had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
had an antisocial personality disorder
had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
had a history of delirium tremens or alcohol withdrawal seizures
reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
reported current or recent treatment with antipsychotics or antidepressants
was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.
Intervention: Humulin N
Trial phase: Phase 1 | Phase 2
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
Admitted (less than 48 hours) to the with worsening heart failure
Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.

Exclusion Criteria:

Type 1 diabetes
Receiving comfort care measures only
Hospital stay expected to be less than 2 days
Pregnancy
Prisoners
Participation in the study on prior hospitalizations
Acute myocardial infarction within 3 months
End stage renal or liver disease
Intervention: Humulin N
Trial phase: Phase 1 | Phase 2
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients received basal and bolus insulin, approximately 5 injections of insulin/day
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
Admitted (less than 48 hours) to the with worsening heart failure
Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.

Exclusion Criteria:

Type 1 diabetes
Receiving comfort care measures only
Hospital stay expected to be less than 2 days
Pregnancy
Prisoners
Participation in the study on prior hospitalizations
Acute myocardial infarction within 3 months
End stage renal or liver disease
Intervention: Erythromycin
Trial phase: Not Applicable
ATC code: D10AF02 | D10AF52 | J01FA01 | S01AA17
SMILES: CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 195
Group description: Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
Eligibility criteria:
Inclusion Criteria:

Any patient 7 years old or older who requires a direct pulp cap of a permanent tooth.
The tooth must exhibit a vital pulp upon exposure.
The exposure can be due to mechanical, traumatic or carious causes.
Patient will be available for the two year follow-up period.

Exclusion Criteria:

Any primary tooth requiring a direct pulp cap.
Tooth demonstrates any radicular radiolucency on a radiograph.
Tooth exhibits spontaneous pain.
Tooth exhibits lingering (more than 5 seconds) pain to temperature or biting stimulus.
Non-English and/or non-Spanish speaking subjects.
Intervention: CALCIUM HYDROXIDE
Trial phase: Not Applicable
SMILES: [Ca+2].[OH-].[OH-]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 181
Group description: Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Eligibility criteria:
Inclusion Criteria:

Any patient 7 years old or older who requires a direct pulp cap of a permanent tooth.
The tooth must exhibit a vital pulp upon exposure.
The exposure can be due to mechanical, traumatic or carious causes.
Patient will be available for the two year follow-up period.

Exclusion Criteria:

Any primary tooth requiring a direct pulp cap.
Tooth demonstrates any radicular radiolucency on a radiograph.
Tooth exhibits spontaneous pain.
Tooth exhibits lingering (more than 5 seconds) pain to temperature or biting stimulus.
Non-English and/or non-Spanish speaking subjects.