anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lithium
Trial phase: Not Applicable
ATC code: N05AN01
SMILES: [Li]
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: patients with OPPG will be treated with lithium for 6 months

Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved.
Eligibility criteria:
Eligibility Criteria

Inclusion Criteria

Age 4 years or greater
Diagnosed with osteoporosis pseudoglioma syndrome (OPPG) or a first degree relative of someone with OPPG. For diagnosis of OPPG, one of the following is required: (1) congenital blindness in a child born into a family with known OPPG where at least one affected family member has had an LRP5 mutation demonstrated or (2) a child with no known family members with OPPG who has congenital blindness, DXA Z-score < -2.0 and mutation in LRP5 documented
No contraindications to lithium carbonate
For women of child bearing age, willing to undergo urine pregnancy test

Exclusion Criteria

Age under 4 years
Not diagnosed with osteoporosis pseudoglioma (OPPG) syndrome or a first degree relative of someone with OPPG, or a member of the Old Order Mennonite community
Pregnant
For women of childbearing age, not willing to undergo urine pregnancy test
Contraindication to Lithium (serum creatinine > 1.3, known cardiovascular disease [history of myocardial infarction, heart failure], currently on diuretic or ACE inhibitor)
Glomerular filtration rate below 80 cc/min
Intervention: Milnacipran
Trial phase: Phase 2 | Phase 3
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
18 through 68 years of age

Exclusion Criteria:

Pregnant or trying to become pregnant
Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
Patients who do not indicate their pain levels as less than substantial despite their best care
History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
Presence of current depression as determined by psychiatric diagnostic interview
Presence of brain lesion on MRI anatomical study
Intervention: Sulfamethoxazole
Trial phase: Not Applicable
ATC code: G01AE10 | J01EC01 | J01EE01 | J04AM08
SMILES: Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: Bactrim: Bactrim DS BID for 3 days
Eligibility criteria:
Inclusion Criteria:

Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery

Exclusion Criteria:

Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization
Allergy to sulfonamides or trimethoprim
Non-English speaking
Pregnancy
Breast feeding
Severe renal impairment (creatinine clearance <30)
Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.
Intervention: Ibrutinib
Trial phase: Phase 2
ATC code: L01EL01 | L01XE27
SMILES: C=CC(=O)N1CCC[C@@H](n2nc(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
Eligibility criteria:
Inclusion Criteria:

Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
Lactating or pregnant
Intervention: Nepafenac
Trial phase: Phase 3
ATC code: S01BC10
SMILES: NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 819
Group description: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Eligibility criteria:
Inclusion Criteria:

Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
Able to understand and sign an informed consent;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
Diabetic retinopathy in the operative eye;
Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
Other protocol-defined exclusion criteria may apply.
Intervention: Bimatoprost
Trial phase: 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: 40
Group description: bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

Any active ocular disease
Anticipated wearing of contact lenses during study
Anticipated use of artificial tears during study
Contraindication to pupil dilatation
Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Subjects will receive Everolimus 10 mg daily

Everolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
18 years or older.
Performance status 70% or better.
Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent.

Exclusion Criteria:

Currently receiving anti-cancer treatment.
Major surgery or traumatic injury within 4 weeks.
Radiotherapy related toxicities.
Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
Receiving other investigational drugs.
Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
Show evidence of disease (cancer).
Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
Active, uncontrolled severe infections
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
Known History of HIV positivity.
Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
Patients with an active, bleeding diathesis.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.

contraception, during the study and for 8 weeks after the end of treatment

Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
History of noncompliance to medical regimens.
Patients unwilling to or unable to comply with the protocol.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.

Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, 18-75 years old
Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
Smoking at least 10 cigarettes per day
Weight of at least 100 lbs (45.4 kg)
Motivation to quit smoking
Stabilized psychotic symptoms
Provision of informed consent for testing and treatment

Exclusion Criteria:

Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
Seizure disorder, recent withdrawal from alcohol or anxiolytics
History of bulimia nervosa, anorexia nervosa, or dementia
History of depression, panic, or bipolar disorders
Pregnancy or lactation
Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
Current use of other smoking cessation treatments
Regular use of non-cigarette tobacco products (> than once/week)
Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
Patients with suicidal ideations or plans
Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
History of, or current, alcohol dependence/abuse
Current use of monoamine oxidase inhibitors (MAOI)
Intervention: Inositol
Trial phase: Phase 1 | Phase 2
ATC code: A11HA07
SMILES: O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.

Inositol: Given PO

Laboratory Biomarker Analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Participants must have ulcerative colitis or Crohn's disease with low grade dysplasia or polyploid dysplasia or have a history of dysplasia and increased positive beta-catenin levels confirmed by a consensus of the study pathologists (2 of 2, or 2 of 3)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Absolute neutrophil count (ANC) > 1,500/uL
Platelets > 100,000/uL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT] =< 1.5 times upper limit of normal
Creatinine within normal institutional limits
International normalized ratio (INR) < 1.5
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of baseline pregnancy test, throughout the duration of the study, and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study and followed until the birth of the child
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Subjects with life-threatening medical conditions that would preclude study treatment intervention and colonoscopy
Participants may not be receiving any other investigational agents
History of allergic reactions to rice or compounds of similar chemical or biologic composition to myo-inositol (i.e., urticaria, dermatologic reaction)
Use of medications known to elevate serum blood glucose; participants on steroids are still eligible, as they will be monitored weekly for fasting blood glucose
Participants with dysplasia-associated lesion or mass (DALM), high-grade dysplasia or invasive colonic carcinoma are excluded

Uncontrolled intercurrent illness including, but not limited to

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Chronic renal failure
Chronic renal insufficiency
Psychiatric illness or social situations that would limit compliance with study requirements
Prior treatment with myo-inositol
History of systemic chemotherapy within 18 months of screening
Subjects taking valproic acid and/or lithium
Diabetes mellitus
History of total proctocolectomy
Concomitant primary sclerosing cholangitis (PSC)
Pregnant or lactating subjects are excluded
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
Eligibility criteria:
Inclusion Criteria:

Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration
Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase

Exclusion Criteria:

Lack of prior treatment with an antidepressant during the current depressive episode
Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
Participants with epilepsy or significant history of seizure disorders
Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Participants who have received electroconvulsive therapy (ECT) in the last 10 years
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of <14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of <3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
Eligibility criteria:
Inclusion Criteria:

Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration
Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase

Exclusion Criteria:

Lack of prior treatment with an antidepressant during the current depressive episode
Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
Participants with epilepsy or significant history of seizure disorders
Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Participants who have received electroconvulsive therapy (ECT) in the last 10 years
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
Eligibility criteria:
Inclusion Criteria:

Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration
Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase

Exclusion Criteria:

Lack of prior treatment with an antidepressant during the current depressive episode
Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
Participants with epilepsy or significant history of seizure disorders
Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Participants who have received electroconvulsive therapy (ECT) in the last 10 years
Intervention: IC Green
Trial phase: Not Applicable
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
Eligibility criteria:
Inclusion Criteria:

Participants will include patients with high risk polyposis syndromes with planned routine endoscopic surveillance for neoplasia or patients with planned endoscopic evaluation of distal colonic lesions suspicious for colorectal polyps or cancer detected on abdominal imaging
Fit for conscious sedation or monitored anesthesia care for colonoscopy-American Society of Anesthesiologists (ASA) Class I or II
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Negative human chorionic gonadotropin (HCG) test for women of child-bearing age. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

Participants with AsA class III, IV, V
Documented allergy to iodine, iodine-containing compounds of ICG
Documented allergy to sulfur containing compounds
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG
History of adverse reactions to endoscopy or sedatives for endoscopy
Pregnant or breast-feeding women
Participants who are unable to discontinue warfarin anticoagulation 5 days before the procedure
Participants taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid
Intervention: Ferumoxides
Trial phase: Phase 3
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 608
Group description: Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
Eligibility criteria:
Key Inclusion Criteria include:

Males and females ≥18 years of age

Participants with IDA defined as having:

Hemoglobin <10.0 g/deciliter (dL)
Transferrin saturation <20%
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

History of allergy to IV iron
Allergy to two or more classes of drugs
Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
Hemoglobin ≤7.0 g/dL
Serum ferritin >600 nanograms/mL