anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Desogestrel and ethinyl estradiol
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CCCCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 209
Group description: Use of oral contraceptive pills prior to controlled ovarian stimulation
Eligibility criteria:
Inclusion Criteria:

Females of couples with an indication for In Vitro Fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) scheduled for their first COS treatment cycle
Females >18 and <=39 years of age at the time of signing informed consent
Body Mass Index (BMI) <= 32 kg/m^2
Normal menstrual cycle length; 24-35 days
Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
Willing and able to sign informed consent

Exclusion Criteria:

History of/or any current endocrine abnormality
Less than 2 ovaries or any other ovarian abnormality (inc.>10mm endometrioma)
Presence of unilateral or bilateral hydrosalpinx
Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5cm
History of recurrent miscarriage (3 or more, even when unexplained)
FSH or LH > 12 IU/L as measured by a local laboratory (sample taken during the early follicular phase: menstrual day 2-5)
Any clinically relevant abnormal laboratory value (FSH, LH, estradiol (E2), Progesterone (P), total Testosterone (T), prolactin, Thyroid Stimulating Hormone (TSH), blood biochemistry, hematology and urinalysis) based on a sample during the screening phase.
Contraindications for the use of gonadotropins (tumors, pregnancy, lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts)
Contraindications for the use of oral contraceptive pills (history of (h/o) thromboembolism, breast cancer, undiagnosed vaginal bleeding)
Recent history of/or current epilepsy, Human Immunodeficiency Virus (HIV) infection, diabetes, cardiovascular, gastrointestinal, hepatic, renal or pulmonary disease
Abnormal karyotyping of the patient or her partner (if karyotyping is performed)
History or presence of alcohol or drug abuse within 12 months of signing the consent
Use of hormonal preparations within one month prior to randomization
Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
Administration of investigational drugs within three months prior to signing the informed consent
Intervention: Caffeine
Trial phase: Phase 1
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
Eligibility criteria:
Inclusion Criteria:

Medically healthy non-smoking, non-obese (≥ 55kg and within 15% of ideal body weight) adult male volunteers 18-45 years of age

Exclusion Criteria:

Subjects with history or presence of glucose 6 phosphate dehydrogenase deficiency, myasthenia gravis, optic neuritis, glaucoma or significant cardiovascular disease (including hypotension, bradycardia or EKG abnormalities), pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease
Subjects with significant blood loss in the prior 56 days, plasma donation within 7 days , hemoglobin <12.0 g/dl or who have participated in another clinical trial within the prior 30 days
Subjects with recent (2-year) history or evidence of alcoholism or drug abuse
Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P-glycoprotein within 30 days prior to the first dose and throughout the study
Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
Subjects who are pregnant or lactating or have hypersensitivity to quinine sulfate, mefloquine, quinidine or hypersensitivity to theophylline or aminophylline.
Intervention: Quinine
Trial phase: Phase 1
ATC code: C01BA01 | C01BA51 | C01BA71 | M09AA72 | P01BC01
SMILES: C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
Eligibility criteria:
Inclusion Criteria:

Medically healthy non-smoking, non-obese (≥ 55kg and within 15% of ideal body weight) adult male volunteers 18-45 years of age

Exclusion Criteria:

Subjects with history or presence of glucose 6 phosphate dehydrogenase deficiency, myasthenia gravis, optic neuritis, glaucoma or significant cardiovascular disease (including hypotension, bradycardia or EKG abnormalities), pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease
Subjects with significant blood loss in the prior 56 days, plasma donation within 7 days , hemoglobin <12.0 g/dl or who have participated in another clinical trial within the prior 30 days
Subjects with recent (2-year) history or evidence of alcoholism or drug abuse
Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P-glycoprotein within 30 days prior to the first dose and throughout the study
Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
Subjects who are pregnant or lactating or have hypersensitivity to quinine sulfate, mefloquine, quinidine or hypersensitivity to theophylline or aminophylline.
Intervention: Fondaparinux
Trial phase: Not Applicable
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 90
Group description: Heparin sulfate infusion at 10 units/kg/hour

Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
Eligibility criteria:
Inclusion Criteria:

All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA

Exclusion Criteria:

Known coagulopathy
History of clinically significant bleeding (GI, cranial, pulmonary)
Need for therapeutic heparinization
ECMO
Intervention: Insulin
Trial phase: Phase 4
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(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)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: 27
Group description: All subjects placed on insulin infusion.

Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Eligibility criteria:
Inclusion Criteria:

Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:

APACHE II score ≥9 (See Appendix 1) OR >2 SIRS criteria with lactate ≥ 4 or BP < 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

Exclusion Criteria:

Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.
Intervention: Cholecalciferol
Trial phase: Early Phase 1
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: vitamin D3, 500 IU capsule once per day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

informed written consent
healthy subjects age 18-64 years old
serum 25-hydroxyvitamin D concentration <62.5 nmol/L (<25 ng/mL)

Exclusion Criteria:

increased risk for infectious endocarditis that require antibiotic prophylaxis prior to periodontal probing
women who are postmenopausal
pregnancy or planned pregnancy within the period of the trial
Periodontitis (attachment loss ≥4 mm and probing depths≥5 mm on at least one interproximal site)
Any need for immediate dental treatment (can be eligible after completion of treatment)
history of hypercalcemia, malabsorption syndrome, abnormal sensitivity to vitamin D or hypervitaminosis D
< 3 teeth with bleeding on probing
< 20 teeth present or <8 interproximal spaces (i.e., papillae) in upper jaw
mean plaque index > 3
Current smoking or former smoking with cessation <5 years ago
regular use of any medication for prevention or treatment of disease (including Aspirin, NSAIDs, corticosteroids, but NOT including contraceptives)
Diabetes mellitus
hypercalcemia (serum calcium > ULN),
hypocalcemia (serum calcium < ULN),
hyperparathyroidism (serum PTH concentration > ULN),
hypoparathyroidism (serum PTH concentration < LLN)
any cardiac rhythm abnormalities on baseline ECG
use of tanning beds/unwillingness to abstain from use of tanning beds during study
planned travel during study period / unwillingness to abstain from travel to the South or High Altitudes
unwillingness to abstain from use of any supplements (including vitamin/mineral and herbal supplements) during study period
Intervention: Insulin
Trial phase: Phase 4
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(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)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: 50
Group description: strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl
Eligibility criteria:
Inclusion Criteria:

Male or female patients ≥ 18 years old undergoing liver transplantation
Patients willing and capable of giving written informed consent for study participation

Exclusion Criteria:

Multi-organ transplant recipients
Patients receiving a liver incompatible with A, B or O blood types
HIV infected patients
Recipients of an organ from an HIV+ donor
Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives
Patients with a co-existing alcoholic disease who have not been abstinent for at least 6 month immediately prior to transplantation and are not expected to be able to remain abstinent after transplantation
Patients who are unlikely to comply with the study requirements or unable to give informed consent
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer or if such therapy is to be instituted posttransplantation
Patients transplanted for hepatocellular carcinoma exceeding 3 nodules or with nodule diameter larger than 5 cm
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadatropin (hCG) laboratory test (> 5 milli-International units (mIU/ml)
Intervention: Bradykinin
Trial phase: Not Applicable
SMILES: N=C(N)NCCC[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H]1CCCN1C(=O)[C@H](CO)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CCCN1C(=O)[C@@H](N)CCCNC(=N)N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.

Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
Eligibility criteria:
Inclusion criteria:

Adults 18 years and greater
Healthy

Exclusion criteria:

PVC < 30
Hypertensive subjects on ACE inhibitors
Pregnant or nursing mothers
Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
Triglycerides > 200
Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
History of cerebrovascular disease
Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
Angiotensin converting enzyme inhibitor use
Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
Other chronic medical illnesses at the discretion of the investigators
Intervention: Gliclazide
Trial phase: Phase 4
ATC code: A10BB09 | G01AE10
SMILES: Cc1ccc(S(=O)(=O)NC(=O)NN2CC3CCCC3C2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
Eligibility criteria:
Inclusion Criteria:

Cohort 1 - metformin treatment

Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
GP considers adequate diet and lifestyle advice given
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
Contactable by telephone

Cohort 2 - 2nd line treatment

Type 2 diabetes
Treated with metformin for more than 3 months; or metformin intolerant
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
No diagnosis of osteoporosis
Contactable by telephone

Exclusion Criteria:

Cohort 1

Type 1 diabetes
HbA1c >9% or <=7%
eGFR<50 ml/min
ALT > 2.5*ULN
Alcohol consumption in excess of 50 units per week
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator

Cohort 2

Type 1 diabetes
HbA1c >9% or <=7%
eGFR< 50 ml/min
ALT > 2.5*ULN
Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
Previous diagnosis of osteoporosis
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Sitagliptin: Sitagliptin 100mg daily for 6 months
Eligibility criteria:
Inclusion Criteria:

Cohort 1 - metformin treatment

Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
GP considers adequate diet and lifestyle advice given
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
Contactable by telephone

Cohort 2 - 2nd line treatment

Type 2 diabetes
Treated with metformin for more than 3 months; or metformin intolerant
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
No diagnosis of osteoporosis
Contactable by telephone

Exclusion Criteria:

Cohort 1

Type 1 diabetes
HbA1c >9% or <=7%
eGFR<50 ml/min
ALT > 2.5*ULN
Alcohol consumption in excess of 50 units per week
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator

Cohort 2

Type 1 diabetes
HbA1c >9% or <=7%
eGFR< 50 ml/min
ALT > 2.5*ULN
Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
Previous diagnosis of osteoporosis
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator
Intervention: Pioglitazone
Trial phase: Phase 4
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
Eligibility criteria:
Inclusion Criteria:

Cohort 1 - metformin treatment

Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
GP considers adequate diet and lifestyle advice given
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
Contactable by telephone

Cohort 2 - 2nd line treatment

Type 2 diabetes
Treated with metformin for more than 3 months; or metformin intolerant
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
No diagnosis of osteoporosis
Contactable by telephone

Exclusion Criteria:

Cohort 1

Type 1 diabetes
HbA1c >9% or <=7%
eGFR<50 ml/min
ALT > 2.5*ULN
Alcohol consumption in excess of 50 units per week
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator

Cohort 2

Type 1 diabetes
HbA1c >9% or <=7%
eGFR< 50 ml/min
ALT > 2.5*ULN
Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
Previous diagnosis of osteoporosis
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator
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: 199
Group description: Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
Eligibility criteria:
Inclusion Criteria:

Undergoing a CT with intravenous contrast as part of clinical care
18 years of age or older
Willingness to have a serum creatinine measured 48-72 hours after study

Presence of one or more risk factors for radiocontrast nephropathy:

Creatinine greater than or equal to 1.4 mg/dL
Estimated Glomerular Filtration Rate (eGFR) of less than 60 mL/min/1.73m2
Diabetes Mellitus
Hypertension being treated with anti-hypertensive mediations
Coronary artery disease

Concurrent use of any of the following nephrotoxic drugs:

Cyclosporine A
Aminoglycosides
Amphotericin
Cisplatin
Non-steroidal anti-inflammatory drugs
Congestive heart failure (active or by history)
Older age (65 years of age or older)
Anemia (hematocrit < 30%)

Exclusion Criteria:

Unable or unwilling to provide informed consent
End-stage renal disease currently undergoing regular hemodialysis
Pregnant
Known allergy to N-acetylcysteine
Too unstable to wait for infusion of medication or placebo
Treating physician using N-Acetylcysteine as part of clinical care
Intervention: Norgestrel
Trial phase: Phase 2
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, non-pregnant, non-lactating
History of migraine headaches without aura for at least 6 months
History of migraine headaches associated with menstruation
Others as directed by FDA-approved protocol

Exclusion Criteria:

History of migraine headaches with aura or focal neurological symptoms
Any contraindication to the use of oral contraceptives
Others as dictated by FDA-approved protocol