anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Omadacycline
Trial phase: Phase 2
ATC code: J01AA15 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(CNCC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
Eligibility criteria:
Inclusion Criteria:

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
Participants must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Must be able to comply with all of the requirements of the study

Exclusion Criteria:

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
Evidence of significant immunological disease
Evidence of liver impairment or disease
Evidence of unstable cardiac disease
Severe renal disease or requirement for dialysis
Evidence of septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
Has received an investigational drug within the past 30 days
Participants who are pregnant or nursing
Unable or unwilling to comply with the protocol requirements
Intervention: Omadacycline
Trial phase: Phase 2
ATC code: J01AA15 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(CNCC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
Eligibility criteria:
Inclusion Criteria:

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
Participants must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Must be able to comply with all of the requirements of the study

Exclusion Criteria:

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
Evidence of significant immunological disease
Evidence of liver impairment or disease
Evidence of unstable cardiac disease
Severe renal disease or requirement for dialysis
Evidence of septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
Has received an investigational drug within the past 30 days
Participants who are pregnant or nursing
Unable or unwilling to comply with the protocol requirements
Intervention: Ofloxacin
Trial phase: Phase 2
ATC code: A02BD10 | J01MA01 | J01MA12 | J01RA05 | J01RA09 | S01AE01 | S01AE05 | S02AA16
SMILES: CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
Eligibility criteria:
Inclusion Criteria:

Female participants, age 18-65 years who have signed the informed consent form
Must have a qualifying acute pyelonephritis
Participants must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Must be able to comply with all of the requirements of the study

Exclusion Criteria:

Males
Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
Infections that require antibacterial treatment for greater than 14 days
Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
Evidence of significant immunological disease
Evidence of liver impairment or disease
Evidence of unstable cardiac disease
Severe renal disease or requirement for dialysis
Evidence of septic shock
Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
Has received an investigational drug within the past 30 days
Participants who are pregnant or nursing
Unable or unwilling to comply with the protocol requirements
Intervention: Brimonidine Tartrate
Trial phase: Phase 2
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: The eye that was treated with Brimonidine Tartrate 0.2%.
Eligibility criteria:
Inclusion Criteria:

1. Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days

Exclusion Criteria:

Subjects with untreated hypertension or baseline BP >160
Subjects with Thyrotoxicosis
Pregnant women or women trying to conceive
Prisoners
Inability consent
Subjects with anatomical narrow angles or who have never had a dilated eye exam
Subjects currently prescribed brimonidine tartrate for glaucoma
Subjects who take topical or systemic alpha agonists
Patients who take monoamine oxidase (MAO) inhibitors
Patients with known severe cardiovascular disease
Intervention: Fidaxomicin
Trial phase: Phase 2
ATC code: A07AA12
SMILES: CCc1c(Cl)c(O)c(Cl)c(O)c1C(=O)OC1C(C)OC(OCC2=CC=CCC(O)C(C)=CC(CC)C(OC3OC(C)(C)C(OC(=O)C(C)C)C(O)C3O)C(C)=CC(C)=CCC(C(C)O)OC2=O)C(OC)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days

Fidaxomicin 200 mg: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.

Fecal Microbiota Transplantation (FMT): Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
Eligibility criteria:
Inclusion Criteria:

Age > 18 years with severe1 or fulminant2 CDI, without an adequate response to metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48 hours
Those with ability to provide informed consent or an alternative decision maker providing assent

Exclusion Criteria:

Those with bowel perforation
Those taking chemotherapy or radiation treatment with absolute neutrophil count of < 1000 cells/mm3
Those with known colonic strictures
Those with subtotal colectomy or planning to have a colectomy
Those with significant ileus
Intervention: Humalog
Trial phase: Phase 2
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)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=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: 42
Group description: Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Eligibility criteria:
Inclusion Criteria:

Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time

Exclusion Criteria:

Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
Participants must not have a total daily insulin dose >100 units
Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
Intervention: Clonidine
Trial phase: Phase 4
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period

Clonidine: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
Eligibility criteria:
Inclusion Criteria:

Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
Gestational age greater than or equal to 36 weeks
Less than or equal to 48 hours of treatment with morphine for NAS

Exclusion Criteria:

Presence of seizures
Congenital malformations, genetic syndromes or the presence of TORCH infections
Major medical problems
Heart rate and/or blood pressure instability
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: 89
Group description: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.

Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years of age at the time of study entry
Recipient of a deceased or living donor kidney transplantation
Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day)
Patient is less than or at 8 weeks post transplant with a negative serum BK Virus screen at 3-4 weeks post transplant
Patient has a tacrolimus drug dose/concentration of > 1 with therapeutic tacrolimus levels.
Women of childbearing potential defined as all women physiologically capable of becoming pregnant, must have reviewed Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) and have a negative pregnancy test upon study entry.
Female (and male) subjects with reproductive potential must agree to use a highly effective method of birth control for the duration of the study. Please note that according to the US product information for MMF/MPA, two reliable forms of contraception must be used simultaneously unless female sterilization, male sterilization, post-menopausal status or total abstinence is the chosen method.

Exclusion Criteria:

Inability or unwillingness of a patient to give written informed consent or comply with study protocol
History of graft loss from acute rejection within 1 year after any previous kidney transplant
History of previous liver, heart, pancreas, or lung transplant
History of cellular rejection of current allograft prior to enrollment.
Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study entry
Female subjects who are pregnant or breast feeding
Participation in any other studies with investigational drugs or regimens in the preceding year from the time of study entry
Any condition or prior treatment which, in the opinion of the investigator, precludes study participation
Patients requiring the use of azathioprine or a class of drugs that inhibit the mammalian target of rapamycin (mTOR inhibitors)
Patients with active peptic ulcer disease
Intervention: Trans sodium crocetinate
Trial phase: Phase 2
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.

Trans-Sodium Crocetinate: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.
Eligibility criteria:
Inclusion Criteria:

Age 40-85, inclusive
Last known well time 15-120 minutes before anticipated study drug injection
Suspected stroke identified by the LAPSS
Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher
No seizure

Exclusion Criteria:

Coma
Rapidly improving neurologic deficit
History of seizures or epilepsy
Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
SBP < 90 or > 220
Major head trauma in the last 24 hours
Recent stroke within 30 days
Known to be pregnant or lactating
Intervention: Fluorocholine F-18
Trial phase: Phase 2 | Phase 3
ATC code: V09IX07
SMILES: C[N+](C)(CF)CCO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: Patients will undergo a single fluorocholine PET imaging study prior to surgery.

18F-Fluorocholine: Given intravenously

Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Eligibility criteria:
Inclusion Criteria:

Biochemically proven hyperparathyroidism and an indication for surgery
Age >= 13 years old
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
Pregnancy.
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
Eligibility criteria:
Key Inclusion Criteria:

Before surgery:

Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery on the index foot
History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Participants received VX-150 1000 mg qd for 2 days.
Eligibility criteria:
Key Inclusion Criteria:

Before surgery:

Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery on the index foot
History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Participants received VX-150 500 mg q12h for 2 days.
Eligibility criteria:
Key Inclusion Criteria:

Before surgery:

Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery on the index foot
History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply