anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Eligibility criteria:
Inclusion Criteria:

Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
Stable doses of anti-malarial or immunosuppressive therapies
Participants must be willing to avoid pregnancy

Exclusion Criteria:

Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
Neuropsychiatric or central nervous system lupus manifestations
Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
History of receiving a solid organ transplant
Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
Evidence of chronic and/or active hepatitis B or C
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.

Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.
Eligibility criteria:
Inclusion Criteria:

Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur fractures Patients age 18 and older Low energy injury

Exclusion Criteria:

Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia Myeloproliferative disorders International Normalized Ratio (INR) > 1.4 Partial Thromboplastin Time (PTT) > 1.4 times normal A history of arterial or venous thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical trial
Intervention: Risdiplam
Trial phase: Phase 2
ATC code: M09AX10
SMILES: Cc1cn2nc(-c3cc(=O)n4cc(N5CCNC6(CC6)C5)ccc4n3)cc(C)c2n1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Participants aged 2-25 years received risdiplam at the dose of 5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20 kg for 12 months.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of 5q-autosomal recessive SMA
Negative blood pregnancy test at screening and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
For Part 1: Type 2 or 3 SMA ambulant or non-ambulant
For Part 2: 1) Type 2 or 3 SMA non-ambulant; 2) RULM entry item A greater than or equal to 2; 3) ability to sit independently as assessed by item 9 of the MFM

Exclusion Criteria:

Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening, or 5 half-lives of the drug, whichever is longer
Concomitant or previous administration of a SMN2-targeting antisense oligonucleotide, SMN2 splicing modifier or gene therapy either in a clinical study or as part of medical care
Any history of cell therapy
Hospitalization for a pulmonary event within the last 2 months or planned at time of screening
Surgery for scoliosis or hip fixation in the one year preceding screening or planned within the next 18 months
Unstable gastrointestinal, renal, hepatic, endocrine, or cardiovascular system diseases as considered to be clinically significant by the Investigator
Presence of clinically significant electrocardiogram abnormalities before study drug administration from average of triplicate measurement or cardiovascular disease indicating a safety risk for participants as determined by the Investigator
Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
Recently initiated treatment (within less than [<] 6 months prior to randomization) with oral salbutamol or another beta 2-adrenergic agonist taken orally
Any prior use of chloroquine, hydroxychloroquine, retigabin, vigabatrin or thioridazine, is not allowed
Ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to Risdiplam or to the constituents of its formulation
Recent history (less than one year) of ophthalmological diseases
Participants requiring invasive ventilation or tracheostomy
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.

Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.
Eligibility criteria:
Inclusion Criteria:

Participant must be willing and able to provide written informed consent for the study
Participant must be greater than or equal to 18 years of age
Participant must be ASA (American Society of Anesthesiologists) class I, II or III
Planned use of neuromuscular blocking drugs
Planned use of endotracheal intubation
Planned for extubation to occur in the OR

Exclusion Criteria:

ASA (American Society of Anesthesiologists) Class IV
Age < 18 years old
Inability to give oral or written consent
Known or suspected neuromuscular disorder impairing neuromuscular function
True allergy to muscle relaxants
A (family) history of malignant hyperthermia
A contraindication for neostigmine or sugammadex administration
Serum creatinine level of greater than 2.0 mg/dL
Surgery where the patient's arm is not available for neuromuscular monitoring
A plan to extubate under deep anesthesia
Pregnant
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.

Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Eligibility criteria:
Inclusion Criteria:

Participant must be willing and able to provide written informed consent for the study
Participant must be greater than or equal to 18 years of age
Participant must be ASA (American Society of Anesthesiologists) class I, II or III
Planned use of neuromuscular blocking drugs
Planned use of endotracheal intubation
Planned for extubation to occur in the OR

Exclusion Criteria:

ASA (American Society of Anesthesiologists) Class IV
Age < 18 years old
Inability to give oral or written consent
Known or suspected neuromuscular disorder impairing neuromuscular function
True allergy to muscle relaxants
A (family) history of malignant hyperthermia
A contraindication for neostigmine or sugammadex administration
Serum creatinine level of greater than 2.0 mg/dL
Surgery where the patient's arm is not available for neuromuscular monitoring
A plan to extubate under deep anesthesia
Pregnant
Intervention: Lorazepam
Trial phase: Not Applicable
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU

Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.
Eligibility criteria:
Inclusion Criteria:

Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
Having bothersome hand tremor in dominant hand with a hand TRS ≥2
On stable medications during last 30 days prior to enrollment.

Exclusion Criteria:

Presence of secondary causes of tremor, such as dystonia and parkinsonism
Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
History of surgical treatment for (ET).
Dementia as defined by DSM-V criteria
Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
Significant renal, hepatic, cardiac and thyroid disease
Intervention: Sulforaphane
Trial phase: Phase 2
SMILES: C[S@@](=O)CCCCN=C=S
Sex: Male
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.

The weight-based dosing schedule is as follows:

3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb
Eligibility criteria:
Inclusion Criteria:

Males between ages 13-30 (inclusive) at the time of the consent
Primary diagnosis of Autism Spectrum Disorder (ASD), confirmed by Diagnostic and Statistical Manual-5 (DSM-5) criteria and meeting the autism cut-off score of 9 or greater on the Autism Diagnostic Observation Schedule-2 (ADOS-2)
Participant is capable of giving written informed consent or has a legally authorized representative (LAR) with sufficient capacity to provide written informed consent on the participant's behalf.
Participant has a reliable informant (parent or caregiver) who has sufficient past and current knowledge of the subject and will oversee the administration of study medication and accompany the subject to each study visit.
Participant and caregiver have reliable means of transportation to attend study visits.

Exclusion Criteria:

Chronic medical illness that is not stable or would pose a risk to the participant if he participates in the trial
History of clinical seizures within the 12 months preceding study enrollment
Known genetic disorder that is presumed to be the cause of autism spectrum disorder (eg., Fragile x syndrome, tuberous sclerosis)
Changes to psychopharmacological medications (e.g., stimulants, antidepressants, anxiolytics, antipsychotics) in the 4 weeks preceding study enrollment
Significant changes to non-pharmacological treatments for ASD in the 4 weeks preceding study enrollment
Chronic treatment with anti-inflammatory agents (e.g., ibuprofen, NSAIDs, corticosteroids)
Clinically significant laboratory abnormalities at Screening visit (e.g., AST/ALT> two times the upper normal limits; serum creatinine > 1.2 mg/dl, TSH outside normal limits)
Clinically significant findings on physical examination that investigator determines could increase risk of harm from participating in the study
Participated in another clinical interventional trial or received an investigational product in the 30 days preceding study enrollment
Previous therapeutic trial of sulforaphane or participation in a clinical trial in which sulforaphane was the investigational agent
Intervention: IC Green
Trial phase: Phase 2 | Phase 3
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: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.

Sentinel Lymph Node Biopsy

indocyanine green (ICG)
Eligibility criteria:
Inclusion Criteria:

Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
Patients who are cleared for surgery

Exclusion Criteria:

History of reaction to ICG, iodides, or technetium radiocolloid
Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
Patients unwilling or unable to sign informed consent
Women who are pregnant or breast-feeding
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.

Ibuprofen
Eligibility criteria:
Inclusion Criteria:

ability to give informed consent
diagnosis of a "severe" hypertensive disorder of pregnancy:
preeclampsia with severe features
chronic hypertension with superimposed preeclampsia with severe features
HELLP syndrome: hemolysis, elevated liver function tests, low platelets
eclampsia
not yet delivered or less than 6 hours after delivery

Exclusion Criteria:

current incarceration
serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
AST (aspartate aminotransferase) >200 unit/L
ALT (alanine aminotransferase) > 200 unit/L
known allergy or sensitivity to NSAIDs or acetaminophen
delivery > 6 hours prior to enrollment
chronic kidney disease
chronic liver disease
prior liver transplant
chronic infectious hepatitis
gastritis
gastro-esophageal reflux disease (GERD)
peptic ulcer disease
bleeding disorder
provider feels that participation is not in the best interest of the patient
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: 15
Group description: Subjects with eGFR above 125 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.

Dapagliflozin: SGLT2 inhibitor

Metformin: Oral diabetes medicine that helps control blood sugar levels.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM)
Hyperfiltration is defined by GFR >135 ml/min•1.73m2
Normofiltration by a GFR = 90-134 ml/min•1.73m2
BMI = 20-45 kg/m2
HbA1c = 7.5% to 12%
Willingness to participate in the 16 week study protocol
Hematocrit >34% --BP < 145/90 mmHg

Exclusion Criteria:

> 300 mg/day albumin excretion
Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy
Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment)
Proliferative diabetic retinopathy
History of cancer or major organ system disease
New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3x ULN or total bilirubin > 2.0 mg/dL (34.2 µmo/L)
Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs
Pregnant or nursing mothers
Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months
Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study
Orthostatic hypotension (> 15/10 mmHg decrease upon standing for 3 minutes)
Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV
Volume depleted patients
Estimated glomerular filtration rate <60 mL/min•1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
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: 15
Group description: Subjects with eGFR below 124 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.

Dapagliflozin: SGLT2 inhibitor

Metformin: Oral diabetes medicine that helps control blood sugar levels.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM)
Hyperfiltration is defined by GFR >135 ml/min•1.73m2
Normofiltration by a GFR = 90-134 ml/min•1.73m2
BMI = 20-45 kg/m2
HbA1c = 7.5% to 12%
Willingness to participate in the 16 week study protocol
Hematocrit >34% --BP < 145/90 mmHg

Exclusion Criteria:

> 300 mg/day albumin excretion
Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy
Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment)
Proliferative diabetic retinopathy
History of cancer or major organ system disease
New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3x ULN or total bilirubin > 2.0 mg/dL (34.2 µmo/L)
Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs
Pregnant or nursing mothers
Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months
Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study
Orthostatic hypotension (> 15/10 mmHg decrease upon standing for 3 minutes)
Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV
Volume depleted patients
Estimated glomerular filtration rate <60 mL/min•1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status