anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: RISUTEGANIB
Trial phase: Phase 2
SMILES: C[C@@H](O)[C@H](NC(=O)[C@H](CS(=O)(=O)O)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)CN)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Luminate 0.5mg
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.

Intra-Ocular Pressure (IOP) is under control (i.e., IOP

≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.

Willing and able to return for all study visits.
Able to meet the extensive post-op evaluation regimen.
Understands and signs the informed consent form.

Exclusion Criteria:

Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
Screening HgA1c blood test > 10.0
Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.
Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
Previous pars plana vitrectomy in the study eye
Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
YAG laser treatment in the study eye in last 30 days prior to study enrollment.
High myopia in the study eye, with a spherical equivalent of >8.00D at screening
Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
Chronic or recurrent uveitis.
Ongoing ocular infection or inflammation in either eye.
A history of cataract surgery complications/vitreous loss in the study eye.
Congenital eye malformations in the study eye.
A history of penetrating ocular trauma in the study eye.
Mentally handicapped.
Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
Nursing female.
Currently participating in any other clinical research study.
Contraindication to the study medication.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
Eligibility criteria:
Inclusion Criteria:

Patients deemed appropriate candidates for simultaneous bilateral total knee arthroplasty.
Patients receiving general anesthesia
Understands the local language and is willing and able to follow the requirements of the protocol
Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

Exclusion Criteria:

Patients less than 18 years of age
Allergy to bupivacaine
Allergy to epinephrine
Patients who are not medically cleared to undergo bilateral total knee replacement surgery, or
Patient-reported liver impairment (per investigator discretion)
Patient-reported renal impairment (per investigator discretion)
Patients receiving spinal anesthesia
Females who are pregnant or lactating
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .

Linagliptin: The subject will receive Linagliptin 5mg orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age: 40 to 80 years
Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes treated with diet only or on a stable dose of metformin monotherapy)
Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer tomography)

Exclusion Criteria:

Acute coronary syndrome or cerebrovascular event within the previous 4 weeks
Body Mass Index (BMI) > 35 kg/m2
HbA1c <6.0% (42 mmol/mol)
Serum creatinine > 2.5 mg/dl
Aspartate Transaminase (AST)/Alanine Transaminase (ALT)>3x upper limit of normal
HbA1c >9.0% (>75 mmol/mol)
Heart failure > New York Heart Association (NYHA) class II
Uncontrolled hypertension (blood pressure > 165 / 100 mmHg)
Treatment with orally administered steroids
New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous 6 weeks
Known Malignancy
Pregnancy or breast feeding women.
Intervention: Qlaira
Trial phase: Phase 4
SMILES: CC12CCC3=C4CCC(=O)C=C4CCC3C1CCC2(O)CC#N.CCCCC(=O)OC1CCC2C3CCc4cc(O)ccc4C3CCC12C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: Estradiol valerate / dienogest

Estradiol valerate / dienogest: One tablet orally for 9 weeks, continuous use
Eligibility criteria:
Inclusion Criteria:

BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception

Exclusion Criteria:

Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
Intervention: Dienogest
Trial phase: Phase 4
ATC code: G03AA16 | G03AB08 | G03DB08 | G03FA15
SMILES: [H][C@@]12CC[C@@](O)(CC#N)[C@@]1(C)CCC1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: Dienogest

Dienogest: One tablet orally for 9 weeks, continuous use
Eligibility criteria:
Inclusion Criteria:

BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception

Exclusion Criteria:

Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
Intervention: Levodopa
Trial phase: Phase 3
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301
Eligibility criteria:
Inclusion Criteria:

Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

Exclusion Criteria:

Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
Pregnant or lactating females or females wishing to become pregnant.
Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 64
Group description: extended-release bupivacaine (EXPAREL)

Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

Benign indication for surgery
Planned multiport laparoscopic or robotic assisted hysterectomy
Non-pregnant
Able to provide informed consent
Owns smartphone or computer with internet access
Willing to provide contact phone number and accept SMS text messages
Ability to speak and read English (because texts and online surveys will be in English only)

Exclusion Criteria:

Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)

Contraindication to study drug

Severe Hepatic disease
Severe Kidney disease
Current use of monoamine oxidase inhibitors
Current use of tricyclic antidepressants
History of substance or alcohol abuse within the past 2 years
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 64
Group description: short-acting bupivacaine

Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Eligibility criteria:
Inclusion Criteria:

Benign indication for surgery
Planned multiport laparoscopic or robotic assisted hysterectomy
Non-pregnant
Able to provide informed consent
Owns smartphone or computer with internet access
Willing to provide contact phone number and accept SMS text messages
Ability to speak and read English (because texts and online surveys will be in English only)

Exclusion Criteria:

Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)

Contraindication to study drug

Severe Hepatic disease
Severe Kidney disease
Current use of monoamine oxidase inhibitors
Current use of tricyclic antidepressants
History of substance or alcohol abuse within the past 2 years
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: 10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

normal saline solution
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate
Intervention: Eplerenone
Trial phase: Phase 3
ATC code: C03DA04
SMILES: [H][C@@]12CC[C@@]3(CCC(=O)O3)[C@@]1(C)C[C@H]1O[C@@]13[C@@]2([H])[C@H](C(=O)OC)CC1=CC(=O)CC[C@@]13C
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Eplerenone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Inspra. Eplerenone is a potassium-sparing diuretic.

Eplerenone: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.
Eligibility criteria:
Inclusion Criteria:

Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to undergo cardiac magnetic resonance (CMR) without sedation
LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac MRI done within 2 weeks of enrollment

Exclusion Criteria:

Non-MR compatible implants
Severe claustrophobia
Gadolinium contrast allergy
Kidney disease
Prior use of or allergy to aldosterone antagonist
Use of other investigational therapy.
Intervention: Phenylephrine
Trial phase: Phase 4
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: Hypotension requiring a rescue bolus
Eligibility criteria:
Inclusion Criteria:

The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
Pregnant women with singleton pregnancy
Gestational age greater than 36 weeks
Cesarean delivery under spinal anesthesia

Exclusion Criteria:

Use of cardiac medication or medication for blood pressure control
Cardiovascular disease
Multiple gestation
Gestation diabetes requiring insulin
History of postoperative nausea and vomiting
Refusal to be in study
Gastric bypass surgery
History of chronic opioid use (chronic pain syndrome)
Emergent caesarean delivery for maternal and/or fetal distress
Eclampsia
Progressive neurologic disease
Infection at insertion site
Allergy to local anesthetics, narcotics or other study medications.
Intervention: Norepinephrine
Trial phase: Phase 4
ATC code: C01CA03
SMILES: NC[C@H](O)c1ccc(O)c(O)c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Hypotension requiring a rescue bolus
Eligibility criteria:
Inclusion Criteria:

The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
Pregnant women with singleton pregnancy
Gestational age greater than 36 weeks
Cesarean delivery under spinal anesthesia

Exclusion Criteria:

Use of cardiac medication or medication for blood pressure control
Cardiovascular disease
Multiple gestation
Gestation diabetes requiring insulin
History of postoperative nausea and vomiting
Refusal to be in study
Gastric bypass surgery
History of chronic opioid use (chronic pain syndrome)
Emergent caesarean delivery for maternal and/or fetal distress
Eclampsia
Progressive neurologic disease
Infection at insertion site
Allergy to local anesthetics, narcotics or other study medications.
Intervention: Nicotine
Trial phase: Phase 3
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 597
Group description: Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
Eligibility criteria:
Inclusion Criteria:

Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

Exclusion Criteria:

History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.

Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.

Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.

Pregnancy or intending to become pregnant.

Hypersensitivity to the product, history of alcohol or substance abuse.
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 8
Group description: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as "lock therapy" in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.
Eligibility criteria:
Inclusion Criteria:

subjects with short bowel syndrome
requirement for central venous access device (CVAD) for long-term TPN administration
age >/= 6 months to < 16 years
ability to initiate rtPA during hospitalization for newly inserted CVAD
ability to be enrolled within 48 hours of CVAD placement.

Exclusion Criteria:

platelet count <50,000
active bleeding
age =/> 16 years at time of consent.
Intervention: Moxonidine
Trial phase: Not Applicable
ATC code: C02AC05 | C02LC05
SMILES: COc1nc(C)nc(Cl)c1NC1=NCCN1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID

Moxonidine: 0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D
Eligibility criteria:
Inclusion Criteria:

Female with age 45 years and older.
Postmenopausal (absence of menstrual periods for a minimum of 12 months) at the moment of Informed Consent sign.
Arterial hypertension grade I / II per ESH/ESC 2013 guidelines (diastolic pressure ≥ 90 and <110 mm Hg, systolic pressure ≥140 and <180 mm Hg).
Not achieving BP targets <140/90 mmHg either during antihypertensive therapy or naive.
Absence of moxonidine or bisoprolol treatment at least 6 months before the study
Osteopenia of lumbar spine and/or proximal part of the femur (osteoporosis T-score from -1 to -2.5 standard deviations [SD]) by X-Ray densitometry.

Signed Informed Consent for participation in the study

-

Exclusion Criteria:

Hypersensitivity to moxonidine, bisoprolol or any other ingredient of the respective formulations
Any Contraindications for moxonidine, bisoprolol
Osteoporosis (Т-score below - 2.5 SD).
Primary or secondary hyperparathyroidism.
Paget's disease of bones.
History of low traumatic bone fractures.
Malabsorption syndrome.
History of gastro-intestinal surgery.
Severe disturbance of peripheral circulation.
Raynaud's disease.
Symptomatic (secondary) hypertension (caused by any primary internal diseases)
Morbid obesity (BMI over 40 kg/m2).
Symptoms of estrogen deficiency such as hot flushes, nights sweat, vaginal dryness
Administration of any hormone-replacement therapy (HRT) or intake of isoflavones
Secondary hypogonadism.
Sistolic BP ≥180 mm Hg and/or Diastolic BP ≥110 mm Hg.
Clinical presentations of cardiovascular disease: coronary heart disease (CHD), history of stroke, transient ischemic attack (TIA), Charcot's syndrome.
Severe heart failure.
Hemodynamically significant congenital heart disease.
Heart rhythm disorders which require permanent use of any antiarrhythmic medications (including β-adrenoblockers and calcium antagonists).
Diabetes mellitus of any genesis.
Severe liver failure.
Severe kidney failure including patients on dialysis
Thyroid diseases accompanied by functional disorders (thyrotoxicosis or uncompensated hypothyroidism).
Alcohol and drug abuse.
Patients with oncological diseases diagnosed within 5 years before IC execution.
Inability of the patient to comprehend the essence of the program and to provide his/her consent for participation in the program.
Patients with any condition, which in the opinion of the Investigator makes the patient unsuitable for inclusion based on clinical judgment.
Corticosteroid therapy

Participation in any other clinical study during the whole course of this investigation including participation in a study within 30 days prior to providing the informed consent for this trial

-
Intervention: Gabapentin
Trial phase: Phase 2 | Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Patients receive gabapentin PO TID for 48 hours after surgery.

Gabapentin: Given PO

Questionnaire Administration: Ancillary studies
Eligibility criteria:
Inclusion Criteria:

Diagnosis of bladder cancer
Anticipated radical cystectomy with ileal conduit or orthotopic neobladder

Exclusion Criteria:

Presence of spinal cord injury including any form of paraplegia or quadriplegia
Allergy to gabapentin
Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire
Illicit drug use (excluding recreational marijuana)
Chronic kidney disease with glomerular filtration rate < 30 ml/min
Pregnancy: All female patients < 55 years old (yo) will be administered a urine pregnancy test prior to enrollment
Non-English speaking patients
Chronic gabapentin, or the similar drug pregabalin, use
Chronic narcotic use (daily or near daily use for > 90 days)
Intervention: Minocycline
Trial phase: Phase 4
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment
Eligibility criteria:
Inclusion Criteria:

diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth

Exclusion Criteria:

pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension