anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy as determined by medical evaluation.
Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
Have clinically significant abnormalities on ECG, as determined by investigator.
Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
Intervention: Brivaracetam
Trial phase: Phase 1
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period and received BRV 200 mg/day, orally from Day 5 to 9 and 100 mg on Day 10 in the multiple dose period.
Eligibility criteria:
Inclusion Criteria:

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator
Subjects are Chinese males and females born in China between 18 and 45 years of age (both inclusive) whose parents are of Chinese origin
Subjects with body mass index (BMI) from 19 to 24 kg/m^2 (both inclusive). Minimum body weight is equal to or more than 50 kg
Subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmHg (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100 beats per minute (bpm) (supine position, inclusive) at Screening Visit
Subjects without clinically relevant abnormalities in a standard 12-lead Electrocardiogram (ECG) at Screening Visit judged by the Investigators
Subjects with laboratory values within the reference range at Screening Visit, or those with values exceeding the reference range but judged by the Investigators to be not clinically significant to their participation in the study

Exclusion Criteria:

Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device)
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
Pregnant, lactating, or sexually active women with childbearing potential who are not using a medically accepted birth control method
Subject has a known hypersensitivity to any components of the IMP or any of its excipients
Subjects with any previous or current cardiovascular, respiratory, hepatic, renal, digestive, endocrine, or nervous system disorder that may affect absorption, secretion, metabolism, or excretion of the investigational product per Investigator judgement
Subjects showing a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis test at Screening Visit
Intervention: Bemnifosbuvir hemisulfate
Trial phase: Phase 3
SMILES: CNc1nc(N)nc2c1ncn2C1OC(COP(=O)(NC(C)C(=O)OC(C)C)Oc2ccccc2)C(O)C1(C)F.CNc1nc(N)nc2c1ncn2C1OC(COP(=O)(NC(C)C(=O)OC(C)C)Oc2ccccc2)C(O)C1(C)F.O=S(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Orally administered, 550 mg twice daily (BID) for 5 days
Eligibility criteria:
Inclusion Criteria:

Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1

Exclusion Criteria:

Clinical signs indicative of COVID-19 illness requiring hospitalization
Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
Known allergy or hypersensitivity to components of study drug
Abnormal laboratory test results at screening
Requirement of any prohibited medications during the study
Other known active viral or bacterial infection at the time of screening, such as influenza
Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: betamethasone

Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
Eligibility criteria:
Inclusion Criteria:

Single trigger injection
First time for the digit
No prior surgery on digit

Exclusion Criteria:

Current oral steroid use
Rheumatoid arthritis
More than one single digit involved
Previous injection in same digit
Prior surgery on same digit
Other injections in the same clinic on the same day
Intervention: Methylprednisolone
Trial phase: Phase 4
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: methylprednisolone

Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Eligibility criteria:
Inclusion Criteria:

Single trigger injection
First time for the digit
No prior surgery on digit

Exclusion Criteria:

Current oral steroid use
Rheumatoid arthritis
More than one single digit involved
Previous injection in same digit
Prior surgery on same digit
Other injections in the same clinic on the same day
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: The solution of saline will be placed into a sterile bowl in the operating area and three lap sponges will be placed in the solution at the beginning of the procedure. Group 1 will undergo application of three normal saline soaked lap sponges to the surgical site. The lap sponges will be removed after three minutes and measurements will be taken for the study.

Saline: After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The saline soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be "rung out" prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient.
Eligibility criteria:
Inclusion Criteria:

• Patients undergoing panniculectomy or abdominoplasty.

Exclusion Criteria:

Prisoners
Pregnant or nursing women
Persons under the age of 18
Preexisting coagulopathy
Preexisting ongoing venous or arterial thrombosis
History of cerebral vascular accident
History of uncontrolled seizure disorder
Documented administration of daily antiplatelet or anticoagulation (e.g. acetylsalicylic acid ,Non-steroidal anti-inflammatory drugs , Warfarin)
Documented allergic reaction to tranexamic acid
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: 5
Group description: The solution of Tranexamic Acid (TXA) will be placed into a sterile bowl in the operating area and three lap sponges will be placed in the solution at the beginning of the procedure. Group 2 will undergo application of three (TXA) soaked lap sponges to the surgical site. The lap sponges will be removed after three minutes and measurements will be taken for the study.

Tranexamic acid: After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The Tranexamic acid soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be "rung out" prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient.
Eligibility criteria:
Inclusion Criteria:

• Patients undergoing panniculectomy or abdominoplasty.

Exclusion Criteria:

Prisoners
Pregnant or nursing women
Persons under the age of 18
Preexisting coagulopathy
Preexisting ongoing venous or arterial thrombosis
History of cerebral vascular accident
History of uncontrolled seizure disorder
Documented administration of daily antiplatelet or anticoagulation (e.g. acetylsalicylic acid ,Non-steroidal anti-inflammatory drugs , Warfarin)
Documented allergic reaction to tranexamic acid
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Liposomal Bupivacaine use as active ingredient in the block

Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Eligibility criteria:
Inclusion Criteria:

Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.

Exclusion Criteria:

Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Ropivacaine use as active ingredient in the block

Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Eligibility criteria:
Inclusion Criteria:

Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.

Exclusion Criteria:

Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Eligibility criteria:
Inclusion Criteria:

Female
Age 18-80
Bilateral reduction mammaplasty
American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
Must choose to receive preoperative nerve block as part of pain management strategy

Exclusion Criteria:

Allergy to dexamethasone or bupivacaine
History of postoperative nausea and vomiting following anesthesia
History of chronic pain conditions
History of narcotic abuse or dependency
History of chronic renal disease
History of chronic liver disease
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Eligibility criteria:
Inclusion Criteria:

Female
Age 18-80
Bilateral reduction mammaplasty
American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
Must choose to receive preoperative nerve block as part of pain management strategy

Exclusion Criteria:

Allergy to dexamethasone or bupivacaine
History of postoperative nausea and vomiting following anesthesia
History of chronic pain conditions
History of narcotic abuse or dependency
History of chronic renal disease
History of chronic liver disease
Intervention: Belumosudil
Trial phase: Phase 2
ATC code: L04AA48
SMILES: CC(C)NC(=O)COc1cccc(-c2nc(Nc3ccc4[nH]ncc4c3)c3ccccc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 200mg qd po.

BN101: BN101 is an orally ROCK2 selective inhibitor
Eligibility criteria:
Inclusion Criteria:

Male and female subjects at least 18 years of age who have had allogenic hematopoietic cell transplant (HCT).
Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD
Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening;
Have persistent cGVHD manifestations and systemic therapy is indicated

Exclusion Criteria:

Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to treatment.
Intervention: Naltrexone
Trial phase: Early Phase 1
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Pre-naltrexone fMRI

Naltrexone: naltrexone 50 mg PO x 1

Post-naltrexone fMRI
Eligibility criteria:
Inclusion Criteria:

Eating disorder diagnosis per DSM-V criteria that is characterized by binge eating (defined as loss of control of eating resulting in large amount of food consumed in a short period of time) and/or purging (e.g., vomiting, excessive exercising, laxative use)
Stable medication regimen (no dose or drug changes in the past 4 weeks)
Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study

Exclusion Criteria:

Pregnant (via UCG)
Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
Non-removable metal in the body
Current naltrexone use
Self-reported opioid use in the past 7 days
A language barrier (e.g., non-English speaking) for the participant that precludes communication and/or ability to complete all study-related requirements.
Intervention: Molnupiravir
Trial phase: Phase 3
ATC code: J05AB18
SMILES: CC(C)C(=O)OC[C@H]1O[C@@H](n2cc/c(=N/O)[nH]c2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 763
Group description: Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Eligibility criteria:
Inclusion Criteria:

Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first detectable SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
Does not have confirmed or suspected COVID-19
Is willing and able to take oral medication
For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse

Exclusion Criteria:

Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents
Has received, is taking, or is anticipated to require any prohibited therapies
Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
Is living in a household with >10 people