anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Padsevonil
Trial phase: Phase 2
SMILES: COCc1nn2c(CN3C[C@@H](CC(F)(F)Cl)CC3=O)c(C(F)(F)F)nc2s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 406
Group description: Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
Eligibility criteria:
Inclusion Criteria:

Subject is an adult (18 years of age or more )
Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study
Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.

Exclusion Criteria:

Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject
Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit
Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (*according to the ASE Guidelines, 2017; Zoghbi et al 2017)
Female subject who plans to be pregnant or is breastfeeding
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Oxytocin: Oxytocin nasal spray.

Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Eligibility criteria:
Inclusion Criteria:

Fit the age requirement: age 5-9
Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
Be in good medical health
Be cooperative with testing
Speak English in the family
Successfully complete an fMRI scan
Full-scale intelligence quotient (IQ)>70

Exclusion Criteria:

Any metal or electromagnetic implants, including:

Cardiac pacemaker
Defibrillator
Artificial heart valve
Aneurysm clip
Cochlear implants
Shrapnel
Neurostimulators
History of metal fragments in eyes or skin
Significant hearing loss or other severe sensory impairment
A fragile health status.
Current use of prescription psychotropic medications that may affect cognitive processes under study.
A history of significant head trauma or serious brain or psychiatric illness
Intervention: 4,4'-Diphenylmethane diisocyanate
Trial phase: Phase 2
SMILES: O=C=Nc1ccc(Cc2ccc(N=C=O)cc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
Eligibility criteria:
Inclusion Criteria:

Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
Pre-bronchodilator FEV1 of ≥50 to <80% predicted normal value after withholding SABA ≥6 hours
Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
Only 2 reversibility testing attempts are allowed

Exclusion Criteria:

Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
Oral corticosteroid use (any dose) within 6 weeks
Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol
Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years
Hospitalized for psychiatric disorder or attempted suicide within 1 year
Unable to abstain from protocol-defined prohibited medications during the study
Intervention: ALBUTEROL
Trial phase: Phase 2
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Eligibility criteria:
Inclusion Criteria:

Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
Pre-bronchodilator FEV1 of ≥50 to <80% predicted normal value after withholding SABA ≥6 hours
Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
Only 2 reversibility testing attempts are allowed

Exclusion Criteria:

Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
Oral corticosteroid use (any dose) within 6 weeks
Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol
Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years
Hospitalized for psychiatric disorder or attempted suicide within 1 year
Unable to abstain from protocol-defined prohibited medications during the study
Intervention: Zeven
Trial phase: Phase 4
ATC code: J01XA04
SMILES: CNC1C(=O)NC2Cc3ccc(cc3)Oc3cc4cc(c3OC3OC(C(=O)O)C(O)C(O)C3NC(=O)CCCCCCCCC(C)C)Oc3ccc(cc3Cl)C(O)C3NC(=O)C(NC(=O)C4NC(=O)C(NC2=O)c2cc(cc(O)c2Cl)Oc2cc1ccc2O)c1ccc(O)c(c1)-c1c(OC2OC(CO)C(O)C(O)C2O)cc(O)cc1C(C(=O)NCCCN(C)C)NC3=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patient will receive a single dose of dalbavancin administered in the BJH ED or ED observation unit for ABSSSI followed by discharge w/ close Infectious Disease outpatient clinic follow-up.

Dalbavancin: Dalbavancin, a lipoglycopeptide antibiotic, has been approved by the FDA for the treatment of ABSSSI caused by Gram-positive bacteria. A single dose of dalbavancin will be administered in the Emergency Department followed by discharge with close outpatient infectious disease clinic follow-up.
Eligibility criteria:
Inclusion Criteria:

Adult (age ≥18 years)

Diagnosis of uncomplicated ABSSSI suspected to be due to Gram-positive bacteria by treating ED clinician, with presence of the following:

Skin lesion size ≥75 cm2 (measured by area of erythema, edema, and/or induration) AND
Signs of systemic inflammation (at least 1 of the following: WBC >12,000 or <4,000 cells/mm3; ≥10% immature neutrophils on peripheral smear; temperature >38.3˚C or <36˚C; heart rate >90 bpm, respiratory rate >20 bpm). Signs of systemic inflammation not required if the patient is age >70 years, has diabetes mellitus, or has been treated with immunosuppressive or chemotherapy in the past 90 days.
Clinical determination by treating ED clinician that patient will need hospital admission for the sole purpose of receiving intravenous antibiotics directed only towards Gram-positive bacteria (e.g., vancomycin, cefazolin) to treat uncomplicated ABSSSI

Exclusion Criteria:

Risk for ABSSSI due to Gram-negative bacteria (neutropenia with absolute neutrophil count <500 cells/µL, HIV or severely immunocompromised, burns, infection after trauma or as a result of an aquatic environment, infection after skin graft)
Any abscess requiring bedside or operative drainage
Infection due to a vascular catheter or prosthetic device
Infection of a diabetic foot ulcer or decubitus ulcer
Necrotizing soft tissue infection
Sepsis (quick SOFA score ≥2) or septic shock (requiring vasopressors to maintain mean arterial pressure ≥65 mmHg despite resuscitation with at least 30mL/kg of IV crystalloid within first 3 hours)
Recent antibiotics in prior 14 days
Hypersensitivity to glycopeptides (vancomycin, televancin, dalbavancin, oritavancin)
Severe renal insufficiency (CrCl <30 mL/min)
Severe hepatic insufficiency (Child-Pugh Class C)
Pregnant or nursing
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 160
Group description: Tasimelteon: Oral capsule
Eligibility criteria:
Inclusion Criteria:

Ability and acceptance to provide written consent, fluent in English;
Healthy subjects with no medical, psychiatric or current sleep disorders;
Men or women between 18-75 years;
Body Mass Index of ≥ 18 and ≤ 30 kg/m2.

Exclusion Criteria:

Major surgery, trauma, illness or immobile for 3 or more days within the past month;
Pregnancy or recent pregnancy (within 6 weeks);
A positive test for drugs of abuse at the screening or evaluation visit.
Intervention: Clindamycin
Trial phase: Phase 3
ATC code: D10AF01 | D10AF51 | G01AA10 | J01FF01
SMILES: [H][C@]1([C@]([H])(NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@H](SC)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Clindamycin Clindamycin 300 mg + placebo. Capsules.

1 capsule tid during 7 days.

Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Eligibility criteria:
Inclusion Criteria:

Patients of both sexes
Age >18 to 70 years
Diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions
History of type 2 diabetes
HbA1C < 8 %
Fasting plasma glucose (FPG) < 180 mg/dL.

Exclusion Criteria:

Aggressive periodontitis
Pregnant or lactating females,
Required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded.
A history of anti-inﬂammatory therapy within preceding six months
Had received a course of periodontal treatment within the last 6 months,
Allergies to penicillin, metronidazole or clindamycin,
Not able to provide consent to participate in the study
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).

Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
Eligibility criteria:
Inclusion Criteria:

Written informed consent (IC) obtained.
HIV-positive adult (age over 18) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months.
Current ART includes either a protease inhibitor or efavirenz.
No documented or suspected resistance to integrase inhibitors or to NRTIs.
No prior history of virologic failure. Failure is defined as a confirmed plasma viral load > 200 cop/ml measured no less than six months after initiation or modification of therapy.
Virological blips accepted only if a single viral load measurement has been between 50-200 cop/ml followed by viral load < 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening.
Documented evidence of at least two HIV viral load < 50 cop/ml measurements during the past 12 months prior to inclusion: one within 6 months prior to screening.
HIV viral load < 50 cop/ml at screening.

BMI>25 kg/m2 and one metabolic syndrome condition, which are

BP ≥ 130/≥ 85 mmHg or hypertension medication currently in use or
fasting glucose ≥ 5.6 mmol/l or B-HbA1C > 42 mmol/mol or diabetes medication currently in use or
HDL < 1.0 mmol/l in men and < 1.3 mmol/l in women or triglycerides ≥ 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
waist circumference > 94 cm in men and >80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation). OR
ultrasound or biopsy proven hepatosteatosis.

Exclusion Criteria:

Within 12 month window period prior to screening, HIV viral load measurement of >50 cop/ml.
More than one consecutive HIV viral load measurements of > 50 cop/ml in the treatment history after initial viral suppression with ART.
Chronic hepatitis B or C.
Daily alcohol consumption ≥ 30 g for men and ≥ 20 g for women.
Pregnancy or planned pregnancy during the study period.
Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start.
Psychiatric disorder, which prevents a study subject to understand the study protocol.
Other serious disease, which prevents a study subject to participate in the study.
For MRI/spectroscopy imaging: metal objects in the body or claustrophobia.
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: 122
Group description: A Fascia Iliaca Compartment Block will be administered in the block room.

Fascia iliaca compartment block: The patient will be brought to the block room within 30 minutes of arriving in recovery. An injection of local anesthetic into the fascia iliaca compartment using ultrasound guidance will be administered. The patient will then be transported back to recovery.

Bupivacaine: A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
Eligibility criteria:
Inclusion Criteria:

Patients over the age of 18
Scheduled for total hip arthroplasty at Henry Ford Hospital
Epidural anesthesia during surgery

Exclusion Criteria:

Pregnancy
Known intolerance to local anesthetic or narcotics
Revision hip surgery
Intervention: NITROUS OXIDE
Trial phase: Phase 2
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour

Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Eligibility criteria:
Inclusion Criteria:

age 18-80
Veterans of the United States Uniformed Services
primary diagnosis of PTSD
sufficient severity of PTSD symptoms
fluency in English
capacity to provide informed consent

Exclusion Criteria:

psychiatric or medical conditions that make participation unsafe
pregnant or nursing females
allergy to nitrous oxide
Intervention: CID 163285897
Trial phase: Phase 1
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy males or females, as determined by medical history and physical examination
Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product
Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state
Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening
Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data
Intervention: Acetazolamide
Trial phase: Phase 4
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants entered into the study as a cohort, will because of their participation, undergo only two additional digital subtraction angiogram (DSA) imaging acquisitions. These will be done in conjunction with their standard diagnostic DSA evaluation and consist of two CBCTPs, one before and one after administration of 1 g acetazolamide through a peripheral IV line. Each CBCTP will require administration of 75-100 mL iodinated contrast medium also through an intravenous line. Neither of these imaging studies will be used for clinical decision making, but would be processed and evaluated at later date for a formal analysis of the results. Following completion of diagnostic imaging subjects will receive the usual standard of care for treatment of their ruptured aneurysm i.e. endovascular embolization or open surgical clipping.
Eligibility criteria:
Inclusion Criteria:

Patients with aneurysmal subarachnoid hemorrhage presenting to our institution within 24 hours of symptom onset
Adults, 18 years of age or older
Women of childbearing potential must not be pregnant (negative urine pregnancy test)

Exclusion Criteria:

Contraindication to acetazolamide (i.e. sulfonamide allergy, renal or liver failure)
Contraindication to contrast media (Allergy or abnormal serum Cr and/or GFR based on current UW guidelines for IV contrast)
Renal insufficiency, history of renal failure or renal transplant
Hunt and Hess grade 1 and 5 (Attached protocol provides details on the grading scale. Grade 1 have lowest yield for vasospasm and Grade 5 are by definition critically ill and unstable patients)
Critically ill patients who are unstable and who cannot undergo scans within the proposed timeline i.e. within 24 hours of the onset of their symptoms.