anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Normal Saline: 1mcg/kg/hr
Eligibility criteria:
Inclusion Criteria:

Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
2. Gender of Patients: Male & female,Age of Patients: 18 and older

Exclusion Criteria:

Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
Eligibility criteria:
Inclusion Criteria:

Written informed consent
Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
C-peptide ≥ 0.8 ng/mL
Body Mass Index ≤ 45.0 kg/m2
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper limit of normal (ULN)
Serum total bilirubin ≥ 1.5*ULN
Creatinine kinase > 3*ULN
Symptoms of severely uncontrolled diabetes
History of malignant or accelerated hypertension
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Intervention: Moxifloxacin
Trial phase: Phase 1
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: 29
Group description: Single oral dose of moxifloxacin 400 mg (1 tablet)
Eligibility criteria:
Inclusion criteria:

healthy female and male subjects
Intervention: Ethanol
Trial phase: Not Applicable
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 523
Group description: Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement

Colloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status 1-3
Body Mass Index < 35
Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

Exclusion Criteria:

cardiac insufficiency (EF<35%)
coronary disease with angina (NYHA IV)
severe chronic obstructive pulmonary disease
coagulopathies
symptoms of infection or sepsis
renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)
ASA Physical Status > 3.
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Active control arm, 10mg/hr continuous.
Eligibility criteria:
Inclusion Criteria:

Doctor diagnosed asthma
Acute asthma exacerbation
Treatment with systemic corticosteroids and nebulized albuterol
Ages 5 to 17 years

Exclusion Criteria:

Other acute or chronic lung disease
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Experimental 10mg/hr pulsed albuterol regimen.
Eligibility criteria:
Inclusion Criteria:

Doctor diagnosed asthma
Acute asthma exacerbation
Treatment with systemic corticosteroids and nebulized albuterol
Ages 5 to 17 years

Exclusion Criteria:

Other acute or chronic lung disease
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Experimental 25mg/hr continuous albuterol.
Eligibility criteria:
Inclusion Criteria:

Doctor diagnosed asthma
Acute asthma exacerbation
Treatment with systemic corticosteroids and nebulized albuterol
Ages 5 to 17 years

Exclusion Criteria:

Other acute or chronic lung disease
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Experimental 25mg/hr pulsed
Eligibility criteria:
Inclusion Criteria:

Doctor diagnosed asthma
Acute asthma exacerbation
Treatment with systemic corticosteroids and nebulized albuterol
Ages 5 to 17 years

Exclusion Criteria:

Other acute or chronic lung disease
Intervention: Magnesium Sulfate
Trial phase: Phase 2 | Phase 3
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
Eligibility criteria:
Inclusion Criteria:

age 4-21 years, inclusive
Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

patient received more than 12 hours of intravenous pain medication prior to enrollment
previous enrollment in this study (only one admission per child is eligible)
history of allergy/intolerance to both intravenous morphine and hydromorphone
known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
patient with greater than 10 admissions for pain crisis in the past year
patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
transfusion within the previous two months
known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
known pulmonary hypertension
pregnancy
diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
current oral magnesium supplementation or current enrollment in another therapeutic study protocol
previously diagnosed clinical stroke
current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
allergy to magnesium sulfate
discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: each subject serves as their own control with one nostril being treated with pulmicort and one not

pulmicort: applied to nasal packing after surgery
Eligibility criteria:
Inclusion Criteria:

hyposmia and nasal obstruction for >12 weeks
bilateral nasal polyposis
candidate for surgery

Exclusion Criteria:

immunocompromised
non-English speaking
prisoner
pregnant/lactating
will not attend follow up appointments
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: AZD1981 400 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: AZD1981 200 mg once daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: AZD1981 100 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: AZD1981 80 mg once daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: AZD1981 40 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: AZD1981 10 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
6 months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Exclusion Criteria:

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids
Intervention: Doxycycline
Trial phase: Not Applicable
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.

doxycycline: doxycycline - 100 mg twice per day, for 2 months
Eligibility criteria:
Inclusion Criteria:

Rheumatoid Arthritis (RA) patients must meet American College of Rheumatology (ACR) criteria for RA
RA patients: duration of disease will be greater than 6 weeks and less than 2 years.
RA patients should have a Disease Activity Score 28 (DAS28) greater than or equal to 5.
PsA patients will be required to have disease duration and DAS28 similar to the RA patients, and to meet Moll and Wright criteria for PsA.
Allowable medications for both groups at study entry will include: prednisone (or equivalent) 5 mg or less per day (stable dose for at least 2 months); methotrexate 15 mg or less per week (stable dose for at least 2 months); and nonsteroidal anti-inflammatory drugs (NSAIDs) at FDA-approved doses.
Healthy controls will be age- and sex-matched individuals with no personal or family history of inflammatory arthritis.

Exclusion Criteria:

Patients who are unable to provide informed consent.
Pregnant or lactating women.
Recent (<3 months prior) use of any antibiotic therapy
Current consumption of probiotics
Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
Prednisone >5 mg/day or equivalent
Use of other disease-modifying antirheumatic drugs (DMARDs) with known antibiotic properties (Gold salts, hydroxychloroquine, sulfasalazine or minocycline).
Use of biologic DMARDs
Known inflammatory bowel disease
Known gastrointestinal (GI) tract neoplasm.
Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
Chronic unexplained diarrhea.
Any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)

Significant liver, renal or peptic ulcer disease, defined as:

Liver: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN)
Renal: Creatinine >1.5 or endstage renal disease
Peptic ulcer disease: recent ulcer or GI bleed (within past 12 months)
Inability or unwillingness to abstain from alcohol consumption.
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks

vancomycin: vancomycin, 250 mg four times a day, for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Rheumatoid Arthritis (RA) patients must meet American College of Rheumatology (ACR) criteria for RA
RA patients: duration of disease will be greater than 6 weeks and less than 2 years.
RA patients should have a Disease Activity Score 28 (DAS28) greater than or equal to 5.
PsA patients will be required to have disease duration and DAS28 similar to the RA patients, and to meet Moll and Wright criteria for PsA.
Allowable medications for both groups at study entry will include: prednisone (or equivalent) 5 mg or less per day (stable dose for at least 2 months); methotrexate 15 mg or less per week (stable dose for at least 2 months); and nonsteroidal anti-inflammatory drugs (NSAIDs) at FDA-approved doses.
Healthy controls will be age- and sex-matched individuals with no personal or family history of inflammatory arthritis.

Exclusion Criteria:

Patients who are unable to provide informed consent.
Pregnant or lactating women.
Recent (<3 months prior) use of any antibiotic therapy
Current consumption of probiotics
Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
Prednisone >5 mg/day or equivalent
Use of other disease-modifying antirheumatic drugs (DMARDs) with known antibiotic properties (Gold salts, hydroxychloroquine, sulfasalazine or minocycline).
Use of biologic DMARDs
Known inflammatory bowel disease
Known gastrointestinal (GI) tract neoplasm.
Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
Chronic unexplained diarrhea.
Any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)

Significant liver, renal or peptic ulcer disease, defined as:

Liver: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN)
Renal: Creatinine >1.5 or endstage renal disease
Peptic ulcer disease: recent ulcer or GI bleed (within past 12 months)
Inability or unwillingness to abstain from alcohol consumption.
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 118
Group description: Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 7 to 11 years of age, inclusive
Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring

Exclusion Criteria:

Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI

Suicide risk as determined by meeting any of the following criteria:

Any suicide attempt
Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Intervention: Daptomycin
Trial phase: Phase 3
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Infusion of Daptomycin (6 mg/kg bodyweight) once daily

Daptomycin: Infusion (6 mg/kg/bodyweight) once daily
Eligibility criteria:
Inclusion Criteria:

Type 1 and Type 2 Diabetes mellitus
MRSA infected foot ulcus Wagner 1-2 without primary surgical intervention
Therapy duration will last at least more than 5 days
men and women age 18 - 80 years
Declaration of patient's consent
Ability and willingness to give written informed consent and to comply with the requirements of the study
Sexually active females, unless surgically sterile, must be willing to use 2 forms of contraception through the end of the study. Sexually active woman must, except if they were surgically sterilized, have to use for already 30 days before first dose of study medication an effective method of pregnancy prevention. Acceptable forms of contraception for female subjects include: oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, absolute waiver of sexual intercourse, use of a condom by the sexual partner, or sterile sexual partner. Male subjects with partners of child-bearing potential should use barrier contraception in addition to having their partners use another method of contraception.

Exclusion Criteria:

Osteomyelitis according to international consensus guideline (3 of 5 criteria apply for diagnosis)
Presence of a severe nephropathy (creatinine clearance < 30 ml/min)
Advanced diabetic retinopathy
Simultaneous participation in another study or participation in a study in the past 30 days
Non permissible concomitant medication e.g. therapy regimen using several antibiotics
Contraindication for antibiotics
Dialysis essential
Pregnancy (to be determined by pregnancy test) or unsafe contraception
Neutropenia
immunosuppression (oral immunosuppressives, Corticoids exaggerating 7.5 mg Prednisolon-equivalents)
Chronic liver disease (AST or ALT increased to 10fold, bilirubin increased to threefold compared to normal values)