anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tacrolimus
Trial phase: Phase 2
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Standard of Care Tacrolimus Drug Dosing

Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
Eligibility criteria:
Inclusion Criteria:

adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

transplant patients with contraindications to tacrolimus
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)

Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
Eligibility criteria:
Inclusion Criteria:

Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.
Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.
Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.

Exclusion Criteria:

Age < 6 months
Documented allergy or adverse effect to ketamine, midazolam or fentanyl
Epistaxis
Partial upper airway obstruction
Oxygen requirement via nasal cannula
Acute mental status changes (e.g. obtunded or somnolent)
Documented increased intracranial pressure or increased ocular pressure
Documented porphyria
Previously involved in the study
Parent or patient refusal
Acutely compromised vitals (hypotension, desaturations, respiratory distress)
Any known heart disease
If any previous opioid use for analgesia during the visit
Need for staples
Scalp wounds
General trauma requiring additional sedation
Patients who received pain medications (acetaminophen or ibuprofen) before laceration repair
Intervention: Fentanyl and midazolam
Trial phase: Phase 4
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)

Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Eligibility criteria:
Inclusion Criteria:

Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.
Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.
Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.

Exclusion Criteria:

Age < 6 months
Documented allergy or adverse effect to ketamine, midazolam or fentanyl
Epistaxis
Partial upper airway obstruction
Oxygen requirement via nasal cannula
Acute mental status changes (e.g. obtunded or somnolent)
Documented increased intracranial pressure or increased ocular pressure
Documented porphyria
Previously involved in the study
Parent or patient refusal
Acutely compromised vitals (hypotension, desaturations, respiratory distress)
Any known heart disease
If any previous opioid use for analgesia during the visit
Need for staples
Scalp wounds
General trauma requiring additional sedation
Patients who received pain medications (acetaminophen or ibuprofen) before laceration repair
Intervention: Amphetamine
Trial phase: Phase 4
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Participants will be told they are receiving Adderall and will actually be administered Adderall.

Adderall: Participants will be administered Adderall
Eligibility criteria:
Inclusion Criteria:

Age (18-24)
College student with at least average IQ
Willingness to standardize caffeine intake to 100 mg on day of study

Exclusion Criteria:

Attention Deficit/Hyperactivity Disorder (ADHD)
First degree relative with ADHD
Unwillingness to comply with caffeine specifications
Regular use of Adderall
Pregnant/breastfeeding
History of substance use disorders
Illicit stimulant use within the last year
Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
Uncontrolled medical illness
Active contagious infection
Intervention: Amphetamine
Trial phase: Phase 4
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Participants will be told they are receiving placebo and will actually be administered Adderall.

Adderall: Participants will be administered Adderall
Eligibility criteria:
Inclusion Criteria:

Age (18-24)
College student with at least average IQ
Willingness to standardize caffeine intake to 100 mg on day of study

Exclusion Criteria:

Attention Deficit/Hyperactivity Disorder (ADHD)
First degree relative with ADHD
Unwillingness to comply with caffeine specifications
Regular use of Adderall
Pregnant/breastfeeding
History of substance use disorders
Illicit stimulant use within the last year
Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
Uncontrolled medical illness
Active contagious infection
Intervention: Trazodone
Trial phase: Phase 3
ATC code: N06AX05
SMILES: O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Trazodone (50-100 mg):

Trazodone: trazodone tablet
Eligibility criteria:
Inclusion Criteria:

Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
Able to speak English
ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months

Exclusion Criteria:

Severe cognitive impairment on Mini-COG cognitive test (score < 3)
Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
Suicidal Ideation
Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score > 5)
Severe restless leg syndrome
Treatment with trazodone in the past one month
Known allergy to trazodone (self-report or by chart review)
Current treatment with monoamine oxidase inhibitors or in the preceding 14 days
Current treatment with linezolid (self-report or by chart review)
Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics
Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control
Life Expectancy < 3 months
Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months
Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial
Intervention: Carvedilol
Trial phase: Phase 2
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.

Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period
Eligibility criteria:
Inclusion Criteria:

History of Type 1 diabetes mellitus for more than 5 years
Age > 18 years
Presence of impaired hypoglycemia awareness/unawareness
Intensive insulin treatment as defined by multiple daily insulin injections (3 or more) or insulin pump therapy
Negative pregnancy test
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

Major medical disorders (including liver disease, cardiovascular disease, kidney disease, chronic obstructive pulmonary disease, asthma, active malignancy or HIV)
Overt diabetes complications (neuropathy, nephropathy, retinopathy)
Presence of anemia
Current or recent use of beta-blocker therapy
Use of diuretics
Allergies or contraindications to beta-blockers or heparin
Use of benzodiazepines
Alcohol, drug or medication abuse
Frequent use of acetaminophen
Intervention: Carvedilol
Trial phase: Phase 2
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.

Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period
Eligibility criteria:
Inclusion Criteria:

History of Type 1 diabetes mellitus for more than 5 years
Age > 18 years
Presence of impaired hypoglycemia awareness/unawareness
Intensive insulin treatment as defined by multiple daily insulin injections (3 or more) or insulin pump therapy
Negative pregnancy test
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

Major medical disorders (including liver disease, cardiovascular disease, kidney disease, chronic obstructive pulmonary disease, asthma, active malignancy or HIV)
Overt diabetes complications (neuropathy, nephropathy, retinopathy)
Presence of anemia
Current or recent use of beta-blocker therapy
Use of diuretics
Allergies or contraindications to beta-blockers or heparin
Use of benzodiazepines
Alcohol, drug or medication abuse
Frequent use of acetaminophen
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participant took one 10 mg dextromethorphan capsule in the morning and one at night for 10 weeks.
Eligibility criteria:
Inclusion Criteria:

Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
Daily self-reported pain of at least 4 out of 10;

3. Meets American College of Rheumatology 2016 case definition criteria for FM;

4. Able to attend UAB for all scheduled appointments;

5. Can complete daily self-reports of pain and other symptoms for duration of project.

Exclusion Criteria:

Blood draw contraindicated or otherwise not able to be performed;
High-sensitivity C-reactive protein (HS-CRP) ≥ 10 mg/L;
Erythrocyte sedimentation rate (ESR) >60 mm/hr;
Positive rheumatoid factor;
Positive anti-nuclear antibody (ANA);
Abnormal thyroid stimulating hormone or free thyroxine;
Diagnosed rheumatologic or auto-immune condition;
Blood or clotting disorder;
Use of blood thinning medication;
Current use of MAOI
Daily consumption of grapefruit juice
Oral temperature >100˚F at baseline;
Febrile illness or use of antibiotics in the 4 weeks before study commencement;
Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement;
Pregnant or planning on becoming pregnant within 6 months, or currently breastfeeding
Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen);
Baseline HADS (Hospital Anxiety and Depression Scale) depression subscale score of ≥16;
Current litigation or worker's compensation claim;
Current participation in another treatment trial;
Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement.
Intervention: Buspirone
Trial phase: Phase 4
ATC code: N05BE01
SMILES: O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: These subjects received buspirone either before driving simulation visit 1 or before driving simulation 2.
Eligibility criteria:
Inclusion Criteria:

Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
Has a valid Driver's License

Exclusion Criteria:

Major sensorimotor handicaps (e.g. deafness, blindness)
Individuals who have never held a valid driver's license
Intellectual Deficiency (Verbal Comprehension Index < 80)
Inadequate command of the English language
Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
Pregnant
Intervention: Buspirone
Trial phase: Phase 4
ATC code: N05BE01
SMILES: O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: These subjects received no medication either before driving simulation visit 1 or before driving simulation 2.
Eligibility criteria:
Inclusion Criteria:

Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
Has a valid Driver's License

Exclusion Criteria:

Major sensorimotor handicaps (e.g. deafness, blindness)
Individuals who have never held a valid driver's license
Intellectual Deficiency (Verbal Comprehension Index < 80)
Inadequate command of the English language
Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
Pregnant
Intervention: Quinolin-8-yl 2-(3-oxo-2-pent-2-enylcyclopentyl)acetate
Trial phase: Phase 2
SMILES: CCC=CCC1C(=O)CCC1CC(=O)Oc1cccc2cccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 10% VDA-1102

10% VDA-1102: 200 mg twice-daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria:

Subject has no clinically significant findings at Baseline
Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
Subject has at any time been given a diagnosis or treatment associated with immunosuppression
Subject has received VDA-1102 in the past
Intervention: Quinolin-8-yl 2-(3-oxo-2-pent-2-enylcyclopentyl)acetate
Trial phase: Phase 2
SMILES: CCC=CCC1C(=O)CCC1CC(=O)Oc1cccc2cccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: 20% VDA-1102

20% VDA-1102: 200 mg once-daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria:

Subject has no clinically significant findings at Baseline
Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
Subject has at any time been given a diagnosis or treatment associated with immunosuppression
Subject has received VDA-1102 in the past
Intervention: Elismetrep
Trial phase: Phase 2
SMILES: O=C(O)c1ccc(S(=O)(=O)N(Cc2ccc(OC(F)(F)F)cc2)c2ncc3ccccc3c2C2CC2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 187
Group description: MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent to participate in this study.
Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Exclusion Criteria:

Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: Patients allocated to receive IV normal saline placebo

Normal saline: Normal saline volume equivalent

none
Eligibility criteria:
Inclusion Criteria:

Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher

Exclusion Criteria:

Patient with fever (38C or 100.4F)
Patient less than age 4 years
Patient greater than age 16 years
Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen
Patient received acetaminophen within the past 4 hours
Patient with known liver disease or renal disease
Patient not requiring IV morphine (pain score 5/10 or less)
Patient enrolled in the study within the past 72 hours
Intervention: Rovalpituzumab tesirine
Trial phase: Phase 2
SMILES: COc1cc2c(cc1OCCCCCOc1cc3c(cc1OC)C(=O)N1C=C(C)CC1C(O)N3C(=O)OCc1ccc(NC(=O)C(C)NC(=O)C(NC(=O)CCOCCOCCOCCOCCOCCOCCOCCOCCNC(=O)CCN3C(=O)CC(SCC(N)C(=O)O)C3=O)C(C)C)cc1)N=CC1CC(C)=CN1C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).
Eligibility criteria:
Inclusion Criteria:

Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.

For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:

Tolerated their initial 2 doses of rovalpituzumab tesirine.
Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate hematologic, kidney, and liver function, per protocol.
In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.

Exclusion Criteria:

Subjects not previously enrolled in a rovalpituzumab tesirine study.
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 310
Group description: Daridorexant was administered as tablets, orally, once daily in the evening.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure;
Male or female aged ≥ 18 years;
Insomnia disorder according to DSM-5 criteria;
Insomnia Severity Index score ≥ 15;
Insufficient sleep quantity as collected subjectively in the sleep diary;
Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

Body mass index below 18.5 or above 40.0 kg/m2;
Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 308
Group description: Daridorexant was administered as tablets, orally, once daily in the evening.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure;
Male or female aged ≥ 18 years;
Insomnia disorder according to DSM-5 criteria;
Insomnia Severity Index score ≥ 15;
Insufficient sleep quantity as collected subjectively in the sleep diary;
Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

Body mass index below 18.5 or above 40.0 kg/m2;
Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.