anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Evobrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N1CCC(CNc2ncnc(N)c2-c2ccc(Oc3ccccc3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Participants who received 75 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply
Intervention: Brimonidine
Trial phase: Phase 1 | Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Brimonidine 0.15% eye drops 2 times a day for 12 weeks

Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older.
Capable of giving informed consent and does provide informed consent.
Diagnosis of Meibomian Gland Disease
Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.

Exclusion Criteria:

Allergic to Brimonidine or any similar products, or excipients of Brimonidine
Currently receiving any Brimonidine preparation as a part of glaucoma management
Receiving or have received within 30 days any experimental systemic medication.
Active ocular infection or ocular allergies.
Any history of eyelid surgery or ocular surgery within the past 3 months.
Corneal epithelial defect larger than 1 mm2 in either eye.
Have active drug/alcohol dependence or abuse history.
Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
Intervention: Brimonidine
Trial phase: Phase 1 | Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.

Brimonidine 0.075%: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older.
Capable of giving informed consent and does provide informed consent.
Diagnosis of Meibomian Gland Disease
Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.

Exclusion Criteria:

Allergic to Brimonidine or any similar products, or excipients of Brimonidine
Currently receiving any Brimonidine preparation as a part of glaucoma management
Receiving or have received within 30 days any experimental systemic medication.
Active ocular infection or ocular allergies.
Any history of eyelid surgery or ocular surgery within the past 3 months.
Corneal epithelial defect larger than 1 mm2 in either eye.
Have active drug/alcohol dependence or abuse history.
Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
Eligibility criteria:
Inclusion Criteria:

positive results of both rapid urease test and histology,
a positive result of urea breath test,
or a positive result of culture.

Exclusion Criteria:

ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
patients with allergic history to the medications used,
patients with previous gastric surgery,
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
pregnant women
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Eligibility criteria:
Inclusion Criteria:

positive results of both rapid urease test and histology,
a positive result of urea breath test,
or a positive result of culture.

Exclusion Criteria:

ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
patients with allergic history to the medications used,
patients with previous gastric surgery,
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
pregnant women
Intervention: Curcumin
Trial phase: Phase 1 | Phase 2
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.

Curcumin: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary sclerosing cholangitis (PSC) established by all of the following criteria:

Alkaline phosphatase >1.5x upper limit of normal for at least 6 months prior to study enrollment
Cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation, beading, and/or strictures consistent with PSC
Liver histology (if available for review) consistent with or diagnostic of PSC
Women of child-bearing potential willing to use birth control for the duration of the study.

Exclusion Criteria:

Treatment with any investigational agents within three months prior to or during the study
Treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, or vitamin E within three months prior to or during the study.
Concomitant treatment with NSAIDS, antiplatelet agents, antihyperlipidemics, and anticoagulant warfarin.
Anticipated need for liver transplant within one year as determined by Mayo PSC risk score (<80% one-year survival without transplant)
Active drug or alcohol use
Findings suggestive of liver disease of an alternative or concomitant etiology, such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g., post-liver transplantation biliary stricture)
Pregnancy or lactation
Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
Intervention: Iron
Trial phase: Not Applicable
ATC code: A11AA01 | B03AE01 | B03AE02 | B03AE03 | B03AE04
SMILES: [Fe]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: standard dose of oral iron pills for one year
Eligibility criteria:
Inclusion Criteria:

Enrollment in the Longitudinal Study of the Porphyrias
Male or female age ≥18 years
History of nonblistering cutaneous photosensitivity
Biochemical findings - A marked increase in erythrocyte protoporphyrin (total erythrocyte protoporphyrin >400 ug/dL) with a predominance of metal-free protoporphyrin
Serum ferritin ≤30 ng/mL at baseline
Able to tolerate oral iron

Exclusion Criteria:

History of liver or bone marrow transplant or clinically significant liver dysfunction as determined by the investigator
Known or suspected allergy to oral iron based on patient report
Clinical evidence of active and ongoing GI bleeding
Use of any other clinical or experimental therapy in the past 3 months
Individuals with elevations of porphyrins in plasma or erythrocytes due to other diseases (i.e. secondary porphyrinemia) such as liver and bone marrow diseases
Patients with any clinically significant comorbid conditions, which in the opinion of the investigator, precludes participation
Intervention: Tamoxifen
Trial phase: Not Applicable
ATC code: L02BA01
SMILES: CC/C(=C(\c1ccccc1)c1ccc(OCCN(C)C)cc1)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Women with a history of high background uptake on MBI were enrolled.

A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
Eligibility criteria:
Inclusion Criteria:The following are requirements for entry into the study:

Female, age 40 or older at the time of enrollment
Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake
Mammogram performed within 12 months prior to enrollment that is available for comparison
Willing and able to return for MBI following 30 days of low-dose tamoxifen

If able to become pregnant

Negative pregnancy test within 48 hours prior to study MBI exam(s)
Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception.

Understands and signs the consent form

-

Exclusion Criteria:Subjects will be excluded if any of the following characteristics are present:

1) Evidence of suspected breast disease as defined by positive findings or recommendation for short-interval follow-up on most recent breast imaging (including mammography, MBI, MRI, ultrasound, etc.) not yet resolved prior to enrollment 2) Breast biopsy or breast surgery performed 6 months prior to enrollment 3) Bilateral breast implants or status post-bilateral prophylactic mastectomy 4) Pregnant or lactating 5) Current or recent use (within 6 months prior to enrollment) of any of the following drugs:

Systemic hormonal therapy (oral or transdermal patch formulations)
Hormonal contraception (oral, transdermal, implanted, or injected formulations)
Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene)
Aromatase inhibitors (anastrazole, letrozole, or exemestane)
GnRH analogs
Prolactin inhibitors
Androgens or antiandrogens
Anticoagulants or "blood thinners" (warfarin, heparin, rivaroxaban and other novel anticoagulants)

Drugs known to be strong inhibitors of CYP2D6, the major P450 enzyme that metabolizes tamoxifen, including:

bupropion (Wellbutrin)
fluoxetine (Prozac)
paroxetine (Paxil)
quinidine (Quinidex) 6) Personal history of any type of malignancy, with the exclusion of non-melanoma skin cancer, diagnosed prior to enrollment 7) Personal history or strong family history of blood clots in legs or lungs (also known as deep vein thrombosis or pulmonary embolism) 8) Personal history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) 9) Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps 10) Any type of retinal disorders or severe cataract 11) Current or former smoker 12) Known carrier of BRCA1 or BRCA2 genetic mutation or known DNA repair defect.
Intervention: Tamoxifen
Trial phase: Not Applicable
ATC code: L02BA01
SMILES: CC/C(=C(\c1ccccc1)c1ccc(OCCN(C)C)cc1)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Women with a history of high background uptake on MBI were enrolled.

A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
Eligibility criteria:
Inclusion Criteria:The following are requirements for entry into the study:

Female, age 40 or older at the time of enrollment
Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake
Mammogram performed within 12 months prior to enrollment that is available for comparison
Willing and able to return for MBI following 30 days of low-dose tamoxifen

If able to become pregnant

Negative pregnancy test within 48 hours prior to study MBI exam(s)
Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception.

Understands and signs the consent form

-

Exclusion Criteria:Subjects will be excluded if any of the following characteristics are present:

1) Evidence of suspected breast disease as defined by positive findings or recommendation for short-interval follow-up on most recent breast imaging (including mammography, MBI, MRI, ultrasound, etc.) not yet resolved prior to enrollment 2) Breast biopsy or breast surgery performed 6 months prior to enrollment 3) Bilateral breast implants or status post-bilateral prophylactic mastectomy 4) Pregnant or lactating 5) Current or recent use (within 6 months prior to enrollment) of any of the following drugs:

Systemic hormonal therapy (oral or transdermal patch formulations)
Hormonal contraception (oral, transdermal, implanted, or injected formulations)
Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene)
Aromatase inhibitors (anastrazole, letrozole, or exemestane)
GnRH analogs
Prolactin inhibitors
Androgens or antiandrogens
Anticoagulants or "blood thinners" (warfarin, heparin, rivaroxaban and other novel anticoagulants)

Drugs known to be strong inhibitors of CYP2D6, the major P450 enzyme that metabolizes tamoxifen, including:

bupropion (Wellbutrin)
fluoxetine (Prozac)
paroxetine (Paxil)
quinidine (Quinidex) 6) Personal history of any type of malignancy, with the exclusion of non-melanoma skin cancer, diagnosed prior to enrollment 7) Personal history or strong family history of blood clots in legs or lungs (also known as deep vein thrombosis or pulmonary embolism) 8) Personal history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) 9) Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps 10) Any type of retinal disorders or severe cataract 11) Current or former smoker 12) Known carrier of BRCA1 or BRCA2 genetic mutation or known DNA repair defect.
Intervention: OMIDENEPAG ISOPROPYL
Trial phase: Phase 3
ATC code: G01AE10
SMILES: CC(C)OC(=O)CNc1cccc(CN(Cc2ccc(-n3cccn3)cc2)S(=O)(=O)c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Eligibility criteria:
Inclusion Criteria:

Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria:

Patients at risk of progression of visual field loss
Patients with severe visual field defect
Patients with any diseases that preclude participation in this study for safety reasons
Intervention: Apixaban
Trial phase: Phase 2
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 126
Group description: Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.

Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.

Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID).
Eligibility criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Males and Females, 28 days to < 18 years of age, inclusive
Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

Exclusion Criteria:

Recent thromboembolic events less than 6 months prior to enrollment
Weight < 3 kg
Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
Artificial heart valves and mechanical heart valves
Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
Active bleeding at the time of enrollment
Any major bleeding other than perioperative in the preceding 3 months
Known intracranial congenital vascular malformation or tumor
Confirmed diagnosis of a GI ulcer
Known antiphospholipid syndrome (APS).

Other protocol defined inclusion/exclusion criteria apply
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Individuals with type 2 diabetes mellitus - dapagliflozin

Dapagliflozin: dapagliflozin, 10mg tablet
Eligibility criteria:
Inclusion Criteria:

25-35 kg/m^2
Normal Glucose Tolerance subjects (24)
Type 2 Diabetic Subjects (24)
Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
Diabetic subjects must have HbA1c <8.0%
Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion Criteria:

Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
Intervention: Apixaban
Trial phase: Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.

Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Eligibility criteria:
Inclusion Criteria:

Age 18 - 80 years old
Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
HASBLED score less than 3
No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

Exclusion Criteria:

Patient with unstable arrhythmias and/or recurrent cardiogenic shock
Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
Patient with permanent pacemaker
Patient who is post valve replacement therapy
Patient who is pregnant.
Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)
Patient with advanced liver disease with coagulopathy
Patient with organized and old left ventricular thrombus