anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levodopa
Trial phase: Phase 4
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Patients will receive titration of L-DOPA from 150 mg to 450 mg.

Levodopa
Eligibility criteria:
Inclusion Criteria:

Age >59 years
DSM 5 non-psychotic Major Depressive Disorder, Dysthymia, or Depression Not Otherwise Specified
Center for Epidemiological Studies Depression (CES-D) Rating Scale > 9
Decreased processing speed (defined as 0.5 SD below age-adjusted norms on the Digit Symbol Test) and decreased gait speed (defined as average walking speed over 15' course < 1 m/s)
Willing and capable of providing informed consent and complying with study procedures
Prefer not to be treated with a standard treatment for MDD, Dysthymia, or Depression NOS (e.g., antidepressant medication or psychotherapy)

Exclusion Criteria:

Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months
History of or current psychosis, psychotic disorder, mania, or bipolar disorder
Diagnosis of probable Alzheimer's Disease, Vascular Dementia, or PD
Mini Mental Status Exam (MMSE) < 25
HRSD ≥ 25 or the presence of significant suicide risk
Current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, dopaminergic agents, or mood stabilizers
History of allergy, hypersensitivity reaction, or severe intolerance to LDOPA
Acute, severe, or unstable medical or neurological illness
Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, history of joint replacement surgery, or history of spine surgery
Hypotension (SBP<90), hypertension (SBP >150 or DBP > 90), past stroke causing sensory or movement deficits, cardiac arrhythmias, or any other severe or uncontrolled cardiovascular disease
Having contraindication to MRI scanning (such as metal in body) or unable to tolerate the scanning procedures
History of significant radioactivity exposure (nuclear medicine studies or occupational exposure)
Presence of a clinically significant brain abnormality, significant anemia, insulin dependent diabetes, a history of cardiovascular disease, or uncontrolled/untreated risk factors for coronary artery disease
Intervention: Mirabegron
Trial phase: Phase 2
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Mirabegron 50 mg orally once every 24 hours starting immediately

Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
Eligibility criteria:
Inclusion Criteria:

Single unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
Serum creatinine within normal range
Ability to tolerate oral fluids and oral pain medication
Able to make informed medical decisions regarding consent
Willingness to follow-up in the Urology Clinic in approximately 30 day
Willing to undergo ureteroscopic extraction should the stone not pass in this time period

Exclusion Criteria:

Adults unable to consent
Age less than 18
Multiple stones
Solitary kidney
Horseshoe kidney
On immunosuppressant therapy
On digoxin
Uncontrolled hypertension (Systolic blood pressure > 170, diastolic blood pressure > 110)
History of ureteral surgery or previous endoscopic procedure
Allergy to mirabegron
Current calcium antagonist or corticosteroid or tamsulosin usage
Patients already taking a beta-adrenergic agonist medication
Renal insufficiency [Glomerular Filtration Rate (GFR) less than 60]
Patients with Childs B and C liver failure

Signs of infection i. Temperature greater than 38 degrees Celsius ii. Urinalysis with any of the following positive:

Positive nitrites
White blood cell count greater than 15/hpf (high powered field)
Positive urine culture [defined as a single isolated bacterial species population of greater than 100,000 Colony Forming Units (CFU)]
Patients with chronic pain already undergoing treatment with narcotic medications
Pregnant women and nursing mothers
Prisoners
No working phone number
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: In week One, each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists Risk Classification I Willingness to participate in two sessions

Exclusion Criteria:

Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa
Intervention: FLUTICASONE PROPIONATE
Trial phase: Not Applicable
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Participants received oral placebo for 12 days postoperatively.
Eligibility criteria:
Inclusion Criteria:

CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
scheduled to undergo endoscopic sinus surgery

Exclusion Criteria:

chronic rhinosinusitis with polyps (CRSwNP)
Aspirin exacerbated respiratory disease
Cystic fibrosis
Immunosuppressive states (Human immunodeficiency virus, transplant)
Oral steroid use within 30 days of surgery
Intervention: FOLIC ACID
Trial phase: Phase 2
ATC code: B03AD01 | B03AD02 | B03AD03 | B03AD04 | B03AD05 | B03AE01 | B03AE02 | B03BB01 | B03BB51 | V04CX02
SMILES: Nc1nc(=O)c2nc(CNc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)cnc2[nH]1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
Eligibility criteria:
Inclusion Criteria:

Age ≥6 years, and
Spina bifida and neuropathic bladder, as determined by the attending physician, and
Utilization of intermittent catheterization for bladder management, and
History of 2 or more urinary tract infections (UTIs) in the past year, and
Community dwelling.

Exclusion Criteria:

Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral reflux, bladder stones, kidney stones, etc), and/or
Uses prophylactic antibiotics, and/or
Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or
Has psychologic or psychiatric conditions influencing the ability to follow instructions, and/or
Participates in another study in which results would be confounded, and/or
Is pregnant or breastfeeding, and/or
Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic serious infections (e.g. viral hepatitides, HIV/AIDs), and/or
Has cancer or an autoimmune disorder, and/or
Has a serious allergy to any component or excipients in the live bacterial combination product, and/or
Has had a change in neurologic status in the previous 2 weeks, and/or
Has taken antibiotic for any reason in the previous 2 weeks, and/or
Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or
Has a current urinary tract infection or urinary tract infection within the previous 2 weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).
Intervention: URSODIOL
Trial phase: Phase 4
ATC code: A05AA01 | A05AA02
SMILES: CC(CCC(=O)O)C1CCC2C3C(O)CC4CC(O)CCC4(C)C3CCC12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.

Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female patients with recurrent C. difficile colitis
18 years of age and older
Capable of giving informed consent

Exclusion Criteria:

Patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. Lactose intolerance or gluten enteropathy are not an exclusion provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen.
Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations.
Patients not available for long-term follow-up (2 months) by their physician will be excluded from the study.
Intervention: Bupivacaine
Trial phase: Phase 2
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: 50
Group description: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position

Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Eligibility criteria:
Inclusion Criteria:

Anticipated length of stay of at least 72 hours
Blunt chest wall trauma with two or more rib or sternal fractures
Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission

Exclusion Criteria:

Known allergy to bupivacaine
Respiratory failure requiring intubation within 24 hours prior to enrollment
Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement
Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure < 55 mmHg)
Signs of active myocardial ischemia or non-ST elevation MI
> 20 rib fractures
Weight < 50 kg or > 150 kg
Pregnancy
Incarceration
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position

0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Eligibility criteria:
Inclusion Criteria:

Anticipated length of stay of at least 72 hours
Blunt chest wall trauma with two or more rib or sternal fractures
Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission

Exclusion Criteria:

Known allergy to bupivacaine
Respiratory failure requiring intubation within 24 hours prior to enrollment
Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement
Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure < 55 mmHg)
Signs of active myocardial ischemia or non-ST elevation MI
> 20 rib fractures
Weight < 50 kg or > 150 kg
Pregnancy
Incarceration
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 1
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Eligibility criteria:
Inclusion Criteria:

Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
Weight >5th percentile and <95th percentile based on age;
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
History of drug allergy or hypersensitivity to oxazolidinones;
Pregnant or breast feeding;
Significant blood loss within 60 days prior to study start;
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 1
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Eligibility criteria:
Inclusion Criteria:

Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
Weight >5th percentile and <95th percentile based on age;
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
History of drug allergy or hypersensitivity to oxazolidinones;
Pregnant or breast feeding;
Significant blood loss within 60 days prior to study start;
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 1
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Eligibility criteria:
Inclusion Criteria:

Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
Weight >5th percentile and <95th percentile based on age;
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
History of drug allergy or hypersensitivity to oxazolidinones;
Pregnant or breast feeding;
Significant blood loss within 60 days prior to study start;
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 1
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Eligibility criteria:
Inclusion Criteria:

Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
Weight >5th percentile and <95th percentile based on age;
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
History of drug allergy or hypersensitivity to oxazolidinones;
Pregnant or breast feeding;
Significant blood loss within 60 days prior to study start;
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 1
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Eligibility criteria:
Inclusion Criteria:

Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
Weight >5th percentile and <95th percentile based on age;
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria:

History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
History of drug allergy or hypersensitivity to oxazolidinones;
Pregnant or breast feeding;
Significant blood loss within 60 days prior to study start;
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.