anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Zibrofusidic acid
Trial phase: Phase 2
SMILES: CC(=O)OC1CC2(C)C(CC(O)C3C4(C)CCC(O)C(C)C4CCC32C)C1=C(CCC(Br)=C(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 2% TD1414 Cream: Application 3 times daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Ability and willingness to comply with all the study requirements/procedures
Age ≥ 18 and ≤65 years
Primary bullous/non-bullous impetigo or SITL

Patients suffering from primary bullous/non-bullous impetigo must have:

Not more than 10 discrete lesions, and
A total lesional area ≥ 1 cm2 and ≤ 100 cm2, and
Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
Total SIRS score equal to or ≥ 8

Patients suffering from SITL must have:

A total infected area of the traumatic lesion ≥ 1 cm2 and ≤ 100 cm2, and
Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
Total SIRS score ≥ 8, and
SITL not caused by burns or animal/human bite
Amenable for treatment with topical antibiotic alone
Body Mass Index ≥18 and ≤ 35 kg/m2.

Exclusion Criteria:

Immunosuppressed state or other serious systemic disease
Signs and/or symptoms of systemic infection, such as malaise and fever or local adenopathy and fever
Unwillingness to abstain from use of any other topical products including emollients on the lesional area during the study
Systemic treatment with antibacterials or immunosuppressive agents (e.g. corticosteroids) within 2 days before day 1 (inhaled/intranasal steroids may be used)
Topical treatment with antibacterials, immunosuppressive agents (e.g. corticosteroids) or antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide, iodine) on the lesional area within 2 days before day 1
Indication for surgical or systemic treatment of the SITL/impetigo
Known or suspected hypersensitivity to any of the components of the study medication
Participation in any other interventional clinical trial or use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to day 1
Previously enrolled in this study
A blood alcohol content ≥ 0.08% as determined by a Breathalyzer test
Known or suspected history of alcohol abuse/alcoholism or drug abuse
Known or suspected impairment of liver function
Heart rhythm disturbances or clinically significant quantitative or qualitative abnormality in the pretreatment ECG
Blood donation in excess of 500mL within 56 days before day 1 or donation during the study or within 3 days of leaving the study.
Intervention: Acipimox
Trial phase: Phase 2 | Phase 3
ATC code: C10AD06
SMILES: Cc1cnc(C(=O)O)c[n+]1[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Acipimox treatment QID for 7 days

acipimox: 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Eligibility criteria:
Inclusion Criteria:

Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:

abdominal obesity
elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL)
low HDL
elevated fasting blood triglycerides (> 150 mg/dL)
hypertension (BP > 140/90 mm HG)
Normal cardiovascular examination

Exclusion Criteria:

Diabetes mellitus
Untreated hypercholesterolemia (LDL > 75th percentile for age)
Cigarette smoking within 1 year
Renal insufficiency (creatinine > 1.4 mg/dl)
Blood dyscrasia
Hepatic dysfunction (ALT > 2x normal)
Evident coronary/peripheral atherosclerosis
Intervention: BQ-123
Trial phase: Phase 2
SMILES: CC(C)C[C@@H]1NC(=O)[C@@H](C(C)C)NC(=O)[C@@H]2CCCN2C(=O)[C@@H](CC(=O)O)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: BQ-123 (6-120 µg/min) will be administered intravenously.
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion Criteria:

hypertension due to other reasons (not pulmonary)
Intervention: TERIPARATIDE
Trial phase: Phase 2
ATC code: H05AA02
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)O)C(C)C)C(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Teriparatide: Teriparatide 20 mcg sc daily for 6 months
Eligibility criteria:
Inclusion Criteria:

Anorexia Nervosa
Women, age 30-70 years
Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)

Exclusion Criteria:

Diseases known to affect bone metabolism
Hyperparathyroidism
Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
Pregnant and/or breastfeeding
Diabetes mellitus
History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
Fractures of a bone other than a finger or toe in last 1 year
Intervention: Salsalate
Trial phase: Phase 2 | Phase 3
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate
Eligibility criteria:
Inclusion Criteria:

Non-smoking adult subjects with known atherosclerosis

Exclusion Criteria:

Uncontrolled hypertension (> 140/90 mmHg)
Untreated hypercholesterolemia (LDL > 160 mg/dL)
Diabetes mellitus
Alanine Aminotransferase > 150
Creatinine > 1.4 mg/dL
Concommitant use of warfarin
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: 55
Group description: Azithromycin 250 mg

1x/day during 5 days 3x/week afterwards
Eligibility criteria:
Inclusion Criteria:

patients who have given written informed consent
males or females of any race
18-75 years of age
with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria:

females who are pregnant or who are breastfeeding
patients with severe bronchiectasis
patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
who are unable to perform spirometry or complete a patient diary or complete questionnaires
patients with known hypersensitivity to azithromycin or other macrolide antibiotics
patients who's heart rate corrected QT interval is prolonged
patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
anti-IgE treatment
Intervention: Ibodutant
Trial phase: Phase 2
SMILES: Cc1ccc2cc(C(=O)NC3(C(=O)N[C@H](Cc4ccccc4)C(=O)NCC4CCN(CC5CCOCC5)CC4)CCCC3)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: oral tablet, once daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients aged 18 - 70 years.
Clinical diagnosis of IBS .
For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
Use of appropriate contraceptive methods.
Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria:

Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
History of gluten enteropathy.
Lactose intolerance as assessed by response to diet
Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
Unstable medical condition.
Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
Pregnancy or breastfeeding.
Patient not able to understand or collaborate throughout the study.
Participation in other clinical trials in the previous 4 weeks.
Intervention: Ibodutant
Trial phase: Phase 2
SMILES: Cc1ccc2cc(C(=O)NC3(C(=O)N[C@H](Cc4ccccc4)C(=O)NCC4CCN(CC5CCOCC5)CC4)CCCC3)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: oral tablet, once daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients aged 18 - 70 years.
Clinical diagnosis of IBS .
For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
Use of appropriate contraceptive methods.
Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria:

Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
History of gluten enteropathy.
Lactose intolerance as assessed by response to diet
Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
Unstable medical condition.
Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
Pregnancy or breastfeeding.
Patient not able to understand or collaborate throughout the study.
Participation in other clinical trials in the previous 4 weeks.
Intervention: Ibodutant
Trial phase: Phase 2
SMILES: Cc1ccc2cc(C(=O)NC3(C(=O)N[C@H](Cc4ccccc4)C(=O)NCC4CCN(CC5CCOCC5)CC4)CCCC3)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: oral tablet, once daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients aged 18 - 70 years.
Clinical diagnosis of IBS .
For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
Use of appropriate contraceptive methods.
Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria:

Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
History of gluten enteropathy.
Lactose intolerance as assessed by response to diet
Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
Unstable medical condition.
Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
Pregnancy or breastfeeding.
Patient not able to understand or collaborate throughout the study.
Participation in other clinical trials in the previous 4 weeks.
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: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Morphine standard of Care pain management

Morphine: Standard of care for pain management of acute episode of pain
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 7 years and less than or equal to 40 years
Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
Admitted to the inpatient unit for further treatment
Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

Diagnosis of acute chest syndrome
New focal neurologic findings or clinical concern of stroke
Aplastic crisis with hemoglobin 2 g/dl below steady-state value
Allergy to morphine or methadone
Any other medical condition that the attending physician deems to be a contraindication to therapy
Liver or renal insufficiency or failure, and congestive heart failure
Intervention: Paliperidone
Trial phase: Phase 4
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 491
Group description: Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Participants who are capable of and willing to fill out the questionnaire for themselves
Participants who are compliant with self-medication or can receive consistent help or support
Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Exclusion Criteria:

Participants with the past history of neuroleptic malignant syndrome (NMS)
Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
Participants who have been exposed to the study drug within one month before screening
Participants with significant risk including suicide or aggressive behavior
Intervention: Tedizolid phosphate disodium salt
Trial phase: Phase 2
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4CC(COP(=O)([O-])[O-])OC4=O)cc3F)cn2)n1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Oral TR-701 200 mg once daily for 5 to 7 days
Eligibility criteria:
Inclusion Criteria:

Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

Complicated skin and skin structure infection due to gram-negative organisms
Complicated skin and skin structure infections requiring more than 7 days of therapy
Uncontrolled diabetes
Chronic systemic immunosuppressive therapy
AIDS with CD4 count < 200 cells/mm3
Uncontrolled hypertension
Mild moderate or severe renal failure
Severe hepatic disease
Neutropenia
Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
Women who are pregnant or nursing
Intervention: Tedizolid phosphate disodium salt
Trial phase: Phase 2
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4CC(COP(=O)([O-])[O-])OC4=O)cc3F)cn2)n1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Oral TR-701 300 mg once daily for 5 to 7 days
Eligibility criteria:
Inclusion Criteria:

Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

Complicated skin and skin structure infection due to gram-negative organisms
Complicated skin and skin structure infections requiring more than 7 days of therapy
Uncontrolled diabetes
Chronic systemic immunosuppressive therapy
AIDS with CD4 count < 200 cells/mm3
Uncontrolled hypertension
Mild moderate or severe renal failure
Severe hepatic disease
Neutropenia
Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
Women who are pregnant or nursing
Intervention: Tedizolid phosphate disodium salt
Trial phase: Phase 2
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4CC(COP(=O)([O-])[O-])OC4=O)cc3F)cn2)n1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Oral TR-701 400 mg once daily for 5 to 7 days
Eligibility criteria:
Inclusion Criteria:

Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

Complicated skin and skin structure infection due to gram-negative organisms
Complicated skin and skin structure infections requiring more than 7 days of therapy
Uncontrolled diabetes
Chronic systemic immunosuppressive therapy
AIDS with CD4 count < 200 cells/mm3
Uncontrolled hypertension
Mild moderate or severe renal failure
Severe hepatic disease
Neutropenia
Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
Women who are pregnant or nursing
Intervention: Ciprofloxacin
Trial phase: Phase 3
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 487
Group description: Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Eligibility criteria:
Inclusion Criteria:

Patient is >/= 2 months of age through 16 years of age
A parent/caregiver must sign an informed consent
Patient must provide assent, as appropriate based on local institutional review board guidelines

Exclusion Criteria:

Patients presenting with the following conditions:

exacerbations of cystic fibrosis (CF)
meningitis
Brain abscess
bacterial endocarditis,
Bone and joint infections

having any of the following conditions but lacking a personal history may be admitted to the trial:

Arthritis
Juvenile rheumatoid arthritis (JRA)
Rheumatoid arthritis (RA)
Systemic lupus erythematosis (SLE)
History of rheumatic fever
Psoriasis
Inflammatory bowel disease
Osteoarthritis (OA)
Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
Patients with any pre-treatment baseline musculoskeletal exam abnormalities
Known risk of experiencing seizures, a history of any convulsive disorders
Requiring any concomitant therapeutic course of systemic antibacterial agent
Participation in any industry-sponsored clinical drug development study within one month prior to this study
Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin > 3 times upper limit of normal)
Known significant renal insufficiency (calculated creatinine clearance of < 30 ml/min/1.73 m²)
Are pregnant or lactating, or are sexually active and using unreliable contraception.
Intervention: Paliperidone
Trial phase: Phase 4
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 387
Group description: Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Eligibility criteria:
Inclusion Criteria:

Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Participants who are compliant with self-medication or can receive consistent help or support
Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)

Exclusion Criteria:

Participants with the past history of neuroleptic malignant syndrome (NMS)
Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
Female participants who are pregnant or are breast feeding
Participants who have participated in any investigational drug trial within 1 month prior to the screening visit