anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rosuvastatin Calcium
Trial phase: Not Applicable
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].[Ca+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Experimental arm

Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Eligibility criteria:
Inclusion Criteria:

Patients with suspected or confirmed influenza (Appendix A)

Requirement for ICU (or ICU step-down) admission due to respiratory distress defined as:

SaO2/FiO2 < 315 or PaO2/FiO2 < 300
Multiply by PB/760 (when altitude exceeds 51000 ft)
For FiO2 for non-intubated patients see Appendix B

Participants must receive the first dose of study drug within 48 hours following ICU admission for confirmed or suspected influenza or be excluded from participation in the study.

Exclusion Criteria:

No consent/inability to obtain consent
Age less than 13 years
Weight less than 40 kg
Unable to receive or unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome)
Allergy or intolerance to statins*
Pregnancy or breast feeding
Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
Requiring statin for underlying disease as determined by the patients attending physician team**.
Severe chronic liver disease (Child-Pugh Score 11-15)
Previous myocardial infarction or thrombotic stroke within the past 6 months 11.12. Any significant funding in the patient's medical history or physical or psychiatric exam prior to randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol
Intervention: Tamsulosin
Trial phase: Phase 3
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 168
Group description: Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced urine flow (measured by special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure.
Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
Have uncontrolled diabetes.
Have prostate cancer, are being treated for cancer.
Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.
Intervention: Humalog
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(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed as having type 2 Diabetes.
Patients who have not been on insulin treatment within 6 months.
Patients who have been taking OADs for at least 90 days.
Patients with an HbA1c level in the range of 7.5% to 11.0%.
Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

Exclusion Criteria:

Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
Patients having or suspected of having malignancy
Patients having serious complications of the heart, liver, or kidney.
Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
Patients receiving systemic steroids.
Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
Intervention: Prasterone
Trial phase: Phase 1
ATC code: A14AA07 | G03EA03 | G03XX01
SMILES: [H][C@]1(O)CC[C@@]2(C)C(=CC[C@]3([H])[C@]2([H])CC[C@]2(C)C(=O)CC[C@@]32[H])C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

DHEA : DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection : Surgical procedure of the invasive breast cancer
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed invasive adenocarcinoma of the breast

Stage I (T1c), II, or III disease (AJCC staging system)

Lesion ≥ 1 cm on breast imaging studies (mammogram, ultrasound, or MRI)
HER2/neu-negative tumor
Planning to receive dehydroepiandrosterone (DHEA) prior to surgery

Disease amenable to surgery with curative intent

Scheduled to undergo surgery immediately after completion of DHEA
No locally advanced or metastatic disease not amenable to surgery

Hormone receptor status:

Estrogen receptor- and progesterone receptor-negative tumor
Androgen receptor-positive tumor

PATIENT CHARACTERISTICS:

Menopausal status not specified
ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
ANC ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 2 times ULN
Hemoglobin > 9 g/dL
Creatinine normal OR creatinine clearance ≥ 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 1 week after completion of study therapy
No history of allergic reactions attributed to compounds of similar chemical or biological composition to DHEA or anastrozole

No concurrent uncontrolled illness, including but not limited to, any of the following:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 5 years since prior surgery, radiotherapy, biological therapy, hormone therapy, and/or chemotherapy for invasive breast cancer
No other concurrent antineoplastic or antitumor agents
No other concurrent investigational agents
Intervention: Dapagliflozin
Trial phase: Phase 2
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: 59
Group description: Dapagliflozin tablet 1 mg once daily
Eligibility criteria:
Inclusion Criteria:

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Exclusion Criteria:

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Intervention: Dapagliflozin
Trial phase: Phase 2
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: 56
Group description: Dapagliflozin tablet 2.5 mg once daily
Eligibility criteria:
Inclusion Criteria:

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Exclusion Criteria:

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Intervention: Dapagliflozin
Trial phase: Phase 2
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: 58
Group description: Dapagliflozin tablet 5 mg once daily
Eligibility criteria:
Inclusion Criteria:

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Exclusion Criteria:

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Intervention: Dapagliflozin
Trial phase: Phase 2
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: 52
Group description: Dapagliflozin tablet 10 mg once daily
Eligibility criteria:
Inclusion Criteria:

Japanese Subjects with type 2 diabetes mellitus.
Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
Provision of informed consent.

Exclusion Criteria:

Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Intervention: MK-8245
Trial phase: Phase 1
SMILES: O=C(O)Cn1nnc(-c2cc(N3CCC(Oc4cc(F)ccc4Br)CC3)no2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: MK-8245, 50 mg, twice daily for 28 days
Eligibility criteria:
Inclusion Criteria:

Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
Subject is willing to follow a weight-maintaining diet and exercise program during the study
Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
Subject has a history of type 1 diabetes
Subject has used contact lenses within the last 6 months
Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
Subject has more than 3 alcoholic beverages per day
Subject has more than 6 servings of caffeine a day
Subject has participated in a previous MK8245 study
Intervention: Brimonidine
Trial phase: Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Eligibility criteria:
Inclusion Criteria:

The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
Anticipated need for ocular surgery during the 12-month study period
Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
Any infectious condition in the study eye
Intervention: Brimonidine
Trial phase: Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Eligibility criteria:
Inclusion Criteria:

The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
Anticipated need for ocular surgery during the 12-month study period
Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
Any infectious condition in the study eye
Intervention: Besifloxacin
Trial phase: Phase 2 | Phase 3
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 474
Group description: 0.6% ophthalmic suspension
Eligibility criteria:
Inclusion Criteria:

Subjects who are at least one year of age.
Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
Subjects who are expected to require treatment with any disallowed medications.
Intervention: Sulfamethoxazole
Trial phase: Phase 3
ATC code: G01AE10 | J01EC01 | J01EE01 | J04AM08
SMILES: Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 212
Group description: Bactrim DS (800/160) 2 pills po BID x 7 days
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

Exclusion criteria include patients with diabetes, HIV, cancer or other immunocompromised patients.
Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
Patients with fever or evidence of systemic infection
Finally, patients with sulfa allergy will be excluded.
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 131
Group description: Participants initially randomized to elagolix received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.

Participants originally randomized to placebo were switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
Eligibility criteria:
Inclusion Criteria:

Be female, aged 18 to 49 years, inclusive.
Have moderate to severe pelvic pain due to endometriosis.
Have a history of regular menstrual cycles.
Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.
Agree to use two forms of non-hormonal contraception during the study.

Exclusion Criteria:

Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening.
Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.
Have had surgery for endometriosis within the last month.
Have had a hysterectomy or bilateral oophorectomy.
Are using systemic steroids on a chronic or regular basis within 3 months.
Have uterine fibroids ≥ 3 cm in diameter.
Have pelvic pain that is not caused by endometriosis.
Have unstable medical condition or chronic disease.
Have been pregnant within the last six months.
Currently breast feeding.
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
Eligibility criteria:
Inclusion Criteria:

Males or females from 18-65 years of age
Meets DSM IV criteria for current cannabis dependence
Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
At least a 2-year history of regular MJ use

Exclusion Criteria:

Abstinent from cannabis more than 2 days at the time of randomization
Active suicidal ideation
Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
Significant medical disorders that will increase potential risk or interfere with study participation,
Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
Inability to understand and/or comply with the provisions of the protocol and consent form
Treatment with an investigational drug during the previous month
Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
Ongoing treatment with medications that may affect study outcomes
Intervention: Alprazolam
Trial phase: Phase 1
ATC code: N05BA12
SMILES: Cc1nnc2n1-c1ccc(Cl)cc1C(c1ccccc1)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.