anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sugammadex Sodium
Trial phase: Phase 4
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.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.

deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists grade 1 or 2
Scheduled for elective laparoscopic gastrectomy

Exclusion Criteria:

Severe respiratory or cardiac disease
Severe hepatic or renal function impairment
On medications affecting neuromuscular function
Known allergy to the drugs to be used
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: 40
Group description: Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine
Eligibility criteria:
Inclusion Criteria:

Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

Patient refusal
American Society of Anesthesiologists physical status classification of 4 or higher
Pre-existing neuropathy in the femoral or sciatic distribution
Coagulopathy
Infection at the site
Chronic opioid use (greater than 3 months)
Pregnancy
Medical conditions limiting physical therapy participation
Any other contra-indication to regional anesthesia
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: 40
Group description: Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline
Eligibility criteria:
Inclusion Criteria:

Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

Patient refusal
American Society of Anesthesiologists physical status classification of 4 or higher
Pre-existing neuropathy in the femoral or sciatic distribution
Coagulopathy
Infection at the site
Chronic opioid use (greater than 3 months)
Pregnancy
Medical conditions limiting physical therapy participation
Any other contra-indication to regional anesthesia
Intervention: Apixaban
Trial phase: Phase 1
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.
Women of childbearing potential allowed. Must be following highly effective methods of contraception

Exclusion Criteria:

Any significant acute or chronic medical illness
History of significant head injury within the last 2 years, including individuals with base of skull fractures
Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study
Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug
History of Gilbert's Syndrome
Inability to tolerate oral medication
Inability to be venipunctured and/or tolerate venous access
Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration

Any laboratory test results outside of the range of normal, confirmed by repeat results of:

Platelet count <150,000 cells/µL
Activated partial thromboplastin time >upper limit of normal (ULN)
International normalized ratio >ULN
Alanine aminotransferase >ULN
Aspartate aminotransferase >ULN
Total bilirubin >ULN
Serum creatinine ≥1.5 mg/dL
Hemoglobin <lower limit of normal (LLN)
Hematocrit <LLN
Intervention: Apixaban
Trial phase: Phase 1
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.
Women of childbearing potential allowed. Must be following highly effective methods of contraception

Exclusion Criteria:

Any significant acute or chronic medical illness
History of significant head injury within the last 2 years, including individuals with base of skull fractures
Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study
Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug
History of Gilbert's Syndrome
Inability to tolerate oral medication
Inability to be venipunctured and/or tolerate venous access
Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration

Any laboratory test results outside of the range of normal, confirmed by repeat results of:

Platelet count <150,000 cells/µL
Activated partial thromboplastin time >upper limit of normal (ULN)
International normalized ratio >ULN
Alanine aminotransferase >ULN
Aspartate aminotransferase >ULN
Total bilirubin >ULN
Serum creatinine ≥1.5 mg/dL
Hemoglobin <lower limit of normal (LLN)
Hematocrit <LLN
Intervention: Apixaban
Trial phase: Phase 1
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.
Women of childbearing potential allowed. Must be following highly effective methods of contraception

Exclusion Criteria:

Any significant acute or chronic medical illness
History of significant head injury within the last 2 years, including individuals with base of skull fractures
Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study
Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug
History of Gilbert's Syndrome
Inability to tolerate oral medication
Inability to be venipunctured and/or tolerate venous access
Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration

Any laboratory test results outside of the range of normal, confirmed by repeat results of:

Platelet count <150,000 cells/µL
Activated partial thromboplastin time >upper limit of normal (ULN)
International normalized ratio >ULN
Alanine aminotransferase >ULN
Aspartate aminotransferase >ULN
Total bilirubin >ULN
Serum creatinine ≥1.5 mg/dL
Hemoglobin <lower limit of normal (LLN)
Hematocrit <LLN
Intervention: Etelcalcetide
Trial phase: Phase 3
ATC code: H05BX04
SMILES: CC(=O)N[C@H](CSSC[C@H](N)C(=O)O)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 884
Group description: Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Eligibility criteria:
Inclusion Criteria:

Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
Subject has known sensitivity to any of the products or components to be administered during dosing
Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
Subject is pregnant or nursing
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: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
Eligibility criteria:
Inclusion Criteria:

patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30

Exclusion Criteria:

contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Eligibility criteria:
Inclusion Criteria:

patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30

Exclusion Criteria:

contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
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: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 30mL Normal Saline
Eligibility criteria:
Inclusion Criteria:

patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30

Exclusion Criteria:

contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Intervention: Curcumin
Trial phase: Phase 1 | Phase 2
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).

Curcumin: 360 mg/day (divided into twice daily oral doses)
Eligibility criteria:
Inclusion Criteria:

DSM-5 diagnosis of schizophrenia
age 18 - 65 years
understand spoken English sufficiently to comprehend testing procedures
corrected vision of at least 20/30
currently prescribed an antipsychotic medication

Exclusion Criteria:

clinically significant neurological disease determined by medical history (e.g., epilepsy)
history of serious head injury (i.e., loss of consciousness > 1 hr., no neuropsychological sequelae, no cognitive rehabilitation post head injury)
sedatives or benzodiazepines within 12 hrs of testing
any psychiatric hospitalization within 3 months prior to study participation
behaviors suggesting any potential danger to self or others within 6 months prior to study participation
antipsychotic dose change more than 50% over the 3 months prior to study participation
acute medical problems or untreated chronic medical conditions within 3 months prior to study participation
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: 8
Group description: Subjects who received belumosudil 200 mg orally daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and has failed at least one line of systemic therapy and is a candidate for additional systemic therapy.
Had a PASI of ≥12
At least 10% of body surface area that is affected by plaque psoriasis.
Willing to avoid tanning devices or sun bathing.
Willing to forgo systemic and topical treatments for psoriasis during the course of the study.
Adequate bone marrow function
Negative urine pregnancy test (for women of childbearing potential)
Agree to use a highly effective method of birth control (< 1% per year failure rate) during the study and for 1 month after the termination of the study.
Willing to complete all study measurements and assessments in compliance with the protocol.

Exclusion Criteria:

Non-plaque or drug-induced psoriasis
Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp

Using any topical therapy except for the following:

Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
Immunosuppressive therapies for 4 weeks prior to study entry
Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
Biologic therapies for 3 months prior to study entry.
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
Viral, fungal, or bacterial skin infection.
Pregnant or lactating woman.
Currently participating in another study with an investigational drug or within 28 days of study entry
History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study

History or presence of any of the following:

Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening
Renal disease and/or serum creatinine > 1.5xULN at screening
Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG
Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening
Subject is receiving any drug that is a strong CYP enzyme inhibitor
Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme
Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.
Intervention: Naltrexone
Trial phase: Not Applicable
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.

Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
Eligibility criteria:
Inclusion Criteria:

Females age 18-65
Meets criteria for 1990 ACR criteria for fibromyalgia
Able to receive venous blood draw twice a week for 16 weeks
Sufficient symptom variability during baseline report
Patient completes daily report during 2 week baseline period at least 80% completion rate.

Exclusion Criteria:

Opioid use
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
Location prohibits travel to Stanford
Blood or clotting disorder
Rheumatologic or autoimmune disease
Acute infection
Baseline blood ESR >60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA
Use of blood thinning medication
Pregnant or currently planning to become pregnant
Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.
Known allergy to Naltrexone or Naloxone
Currently participating in another treatment-based research study
Self-reported inability to refrain from alcohol for the duration of the study period
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Have provided written informed consent to participate in the study in accordance with the local ethics committee regulations
Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have chronic sputum production, defined as a greater than 45 mililitres volume produced in the 1 week prior to study entry.
Be able to perform reproducible spirometry
Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by the absence of the following: respiratory exacerbations requiring hospitalisation, change in cough and/or sputum production, new or increased hemoptysis, more than 10% weight loss, use of additional antibiotic courses

Exclusion Criteria:

Subjects will be excluded if one or more of the following criteria occur. The subject: Is an investigator, or an immediate family member of an investigator
Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a sweat test result more than 60mmol/L
Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory exacerbation requiring hospitalisation or additional course of antibiotics in the 6 weeks prior to study entry
Has been prescribed or used oral steroids on any occasion for the 3 months prior to study entry.
Has been using mucolytic agents on any occasion for the 2 months prior to study entry Has active tuberculosis
Has an active malignancy, including melanoma (other skin carcinomas excluded)
Has a history of significant liver disease or insufficiency Has a significant history of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or allergy to macrolides
Has been participating in another interventional drug study in the 3 months prior to enrolment into this study
Intervention: Hydromorphone
Trial phase: Phase 4
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: Patients will receive hydromorphone 2 mg at the end of the surgical procedure

Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia
Eligibility criteria:
Inclusion Criteria:

All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)
American Society of Anesthesiologists Physical Status IV or V
Pulmonary disease necessitating home oxygen therapy
Allergy to methadone or hydromorphone
Preoperative recent history of opioid or alcohol abuse
Inability to use a PCA device or speak the English language