anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 52
Group description: This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
Eligibility criteria:
Inclusion Criteria:

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total knee replacement.
No focal neurologic deficit of the surgical lower extremity.
Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
Body mass index (BMI) > 40 kg/m2
Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

Major systemic medical problems such as:

Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
Impaired cognitive function or inability to understand the study protocol
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
Previous contralateral knee replacement managed with regional or periarticular injection
Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).

0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)

Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
Eligibility criteria:
Inclusion Criteria:

ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
ability to communicate in English.

Exclusion Criteria:

allergy to M or HM
patient on regular chronic opioid medication
patient uncontrolled systemic disease
severe obesity with a BMI >35
significant psychological impairment
history of drug addiction or dependence
any planned regional or nerve block other than local anesthesia infiltration patients with confirmed sleep apnea
emergency surgeries and urological surgeries
Intervention: Hydromorphone
Trial phase: Not Applicable
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: No
Participants at risk: 202
Group description: Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).

0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)

Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
Eligibility criteria:
Inclusion Criteria:

ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
ability to communicate in English.

Exclusion Criteria:

allergy to M or HM
patient on regular chronic opioid medication
patient uncontrolled systemic disease
severe obesity with a BMI >35
significant psychological impairment
history of drug addiction or dependence
any planned regional or nerve block other than local anesthesia infiltration patients with confirmed sleep apnea
emergency surgeries and urological surgeries
Intervention: Mupirocin
Trial phase: Not Applicable
ATC code: D06AX09 | R01AX06
SMILES: C/C(=C\C(=O)OCCCCCCCCC(=O)O)C[C@@H]1OC[C@H](C[C@@H]2O[C@H]2[C@@H](C)[C@H](C)O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 147
Group description: Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.

Mupirocin and Chlorhexidine
Eligibility criteria:
Inclusion Criteria:

Neonate has never had a clinical or surveillance culture grow S. aureus
Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, the cultures will be performed as part of the pre-randomization screening process)
Parent(s) is(are) able to visit the child at the bedside
Parent(s) test positive for S. aureus at screening
Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).
Parents is(are) willing to be randomized
No documented or reported allergies to any agent used in either treatment regimen
Able to perform written informed consent

Exclusion Criteria:

Allergies to any agent used in either treatment regimen
Neonate has had a prior clinical or surveillance culture grow S. aureus
Neonate admitted to NICU from home and is greater than 7 days of age
Neonate admitted to NICU from another hospital and is greater than 7 days of age
Neonate is a ward of the State
Not able to provide written informed consent
Intervention: Moxifloxacin
Trial phase: Phase 4
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.

Moxifloxacin: 400 mg, once in a day for 7 days.
Eligibility criteria:
Inclusion Criteria:

The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.
Patients were included if they were between 18 and 35 years of age and otherwise healthy.

Exclusion Criteria:

if the patients had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases)
history of hepatitis or HIV infection,
immunosuppressive chemotherapy
current pregnancy, planning a pregnancy or lactation
requirement for antibiotic prophylaxis
oral diseases other than GAgP, ongoing orthodontic therapy
a history of antibiotic therapy or periodontal treatment within the preceding six months.
Subjects were excluded if they had known allergies to quinolones or penicillin or metronidazole
Not willing to participate to the study.
Not accept to sign written informed consent
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
Eligibility criteria:
Inclusion Criteria:

Female and male over 18 years old
Unconscious survivors of cardiac arrest treated with therapeutic hypothermia
Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest
PCI with stent implantation
Provision of informed consent prior to any study specific procedures is impossible because subjects are unconscious at the moment of inclusion

Exclusion Criteria:

Use of any P2Y12 inhibitors in last 10 days
Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor
Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor
Thrombocytopenia (<50*109/L)
Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor
Ticagrelor contraindications: previous intracranial bleeding, active pathological bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation
Suspected or confirmed pregnancy
Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Eligibility criteria:
Inclusion Criteria:

Female and male over 18 years old
Unconscious survivors of cardiac arrest treated with therapeutic hypothermia
Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest
PCI with stent implantation
Provision of informed consent prior to any study specific procedures is impossible because subjects are unconscious at the moment of inclusion

Exclusion Criteria:

Use of any P2Y12 inhibitors in last 10 days
Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor
Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor
Thrombocytopenia (<50*109/L)
Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor
Ticagrelor contraindications: previous intracranial bleeding, active pathological bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation
Suspected or confirmed pregnancy
Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor
Intervention: CID 12303048
Trial phase: Phase 3
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 249
Group description: Chlorhexidine Gluconate 2%

2% CHG Cloth: CHG solution on cloth
Eligibility criteria:
Inclusion Criteria:

Free of skin disorders
Signed consent

Exclusion Criteria:

Allergies to latex
Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
severe illness
Pregnant (females)
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 64
Group description: GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
Eligibility criteria:
Key Inclusion Criteria:

Participant must have been male or female, aged between 2 and 18 years (inclusive).
Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.
Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.
All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

Participant had clinically significant unstable medical conditions other than epilepsy.
Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.
Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.
Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
There were plans for the participant to travel outside their country of residence during the study.
Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 69
Group description: GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
Eligibility criteria:
Key Inclusion Criteria:

Participant must have been male or female, aged between 2 and 18 years (inclusive).
Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.
Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.
All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

Participant had clinically significant unstable medical conditions other than epilepsy.
Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.
Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.
Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
There were plans for the participant to travel outside their country of residence during the study.
Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.
Intervention: Hydroxyurea
Trial phase: Phase 1 | Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Hydroxyurea is given to the patients as per a dosing algorithm.
Eligibility criteria:
INCLUSION CRITERIA:

Age greater than or equal to 15 years
Homozygous sickle cell disease (HbSS)
Patients with recent transfusion must have HbA <15% prior to enrollment
ANC greater than or equal to 2,000/microL, platelets greater than or equal to150,000/microL, Hb > 5.4g/dL, and ARC greater than or equal to100,000/microL (unless the Hb is > 8g/dL) at baseline
Patients on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers should be on a stable dose for 2 weeks prior to initiating or adjusting HU

EXCLUSION CRITERIA:

Pregnant or lactating women or patients planning to get pregnant during the study period
Patients unwilling to use two forms of contraception throughout the period of HU administration
Patients receiving chronic transfusion therapy
Patients receiving a HU dose of greater than or equal to 20 mg/kg/day
Patients with history of allergy or intolerance to HU judged by the investigator to be prohibitive against restarting HU

6 Patients with end stage renal disease defined as GFR <10mL/min/1.73m(2)

7. Patients being treated with antiretroviral agents (such as didanosine and stavudine) because of a higher risk for potentially fatal pancreatitis, hepatic failure, hepatitis, and severe peripheral neuropathy when co-administered with hydroxyurea.

8. Participation on any other chronic investigative treatment studies

9. Unable to understand the investigational nature of the study or give informed consent.
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 278
Group description: Receive Lantus® plus insulin lispro

Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
Eligibility criteria:
Inclusion Criteria:

Patients with an established diagnosis of T1DM per ADA 2014 criteria
Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.
Hemoglobin ≥9.0 g/dL at screening.

Exclusion Criteria:

History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
History of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
History of use of a regular immunomodulator therapy in the 1 year prior to screening.
History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I), as judged by the investigator.
History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
History of drug or alcohol dependence or abuse during the 1 year prior to screening.
Intervention: Qsymia
Trial phase: Phase 4
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)

Qsymia
Eligibility criteria:
Key Inclusion Criteria:

Male or female 18 - 65 years of age, medically healthy with no clinically significant screening abnormalities
BMI of ≥27 to ≤45 kg/m2
No use of any medication (prescription, over the counter (OTC) or herbal preparations) with the exception of contraception for the entirety of the study

Key Exclusion Criteria:

Allergy or hypersensitivity to radio contrast media, iodine or shellfish
Plans to significantly alter their diet through fasting, very low caloric intake, elimination of certain foods (gluten, milk, meat, etc.) or similar
Plans to undertake a significant change to physical exercise levels (i.e., initiate training for a marathon) during the study period
Consumption of a high protein diet or protein/body building meal supplementation and/or replacement. The use of any product containing creatine is strictly prohibited
History of glaucoma or increased intraocular pressure
History of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression, current depression of moderate or greater severity, presence or history of suicidal behavior or ideation with some intent to act on it
Cholelithiasis (gallstones) within the past 6 months
History of nephrolithiasis (kidney stones)
Evidence of any clinically significant renal, pulmonary, hepatic, psychiatric or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations or confound the interpretation of study results as determined by the investigator
Current use of any tobacco products including cigarettes, cigars, pipes, and chewing tobacco, or nicotine replacement products (e.g., patch, gum, lozenge, etc.), or chronic use within the previous three months prior to screening