anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
Eligibility criteria:
Inclusion Criteria:

Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"

Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria

Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)

Exclusion Criteria:

Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:

Delirium, dementia, amnestic disorder, or other cognitive disorders
Schizophrenia or other psychotic disorder
Personality disorder
Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Subjects who represent a significant risk of committing suicide
Subjects known to have a complication of allergy to aripiprazole, other quinolinone-skeleton compounds, lithium, or valproate
Subjects with a complication of neuroleptic malignant syndrome
Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
Subjects with a complication of paralytic ileus
Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
Subjects with a complication of diabetes
Intervention: Nitric Oxide
Trial phase: Phase 3
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Eligibility criteria:
Inclusion Criteria:

Confirmed or suspected infection (acute)

PLUS:

One or both of the following criteria for potential tissue hypoperfusion:

(2a) systolic blood pressure <90 mmHg despite 30cc/kg intravenous crystalloid challenge, OR (2b) serum lactate >4 mmol/L.

Exclusion Criteria:

age < 14 years
pregnancy
"Do Not Resuscitate" status (prior to enrollment)
active clinically significant bleeding of any etiology
status-post cardiac arrest
need for immediate surgery
inability to place a sublingual videomicroscopy probe under the tongue (e.g. inability to open the mouth or patient requirement of a high-flow face mask for supplemental oxygen [although videomicroscopy can be performed in patients with an endotracheal tube or nasal cannula])
>24 hours elapsed since first documented evidence of meeting criteria for potential tissue hypoperfusion (2a or 2b above).
inability to obtain written informed consent
Intervention: Perillyl alcohol
Trial phase: Phase 2
SMILES: C=C(C)C1CC=C(CO)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Resident of Pima or adjoining Southern Arizona county

Patients outside of Pima County are also eligible

Sun damaged skin as judged by the study physician and quantifiable, clinically diagnosed, and visible actinic keratoses (AK) on both dorsal forearms, with at least two AK on each arm

AK lesions must not be clustered, confluent, or too numerous to count accurately
Presence of AK on sites other than the test area allowed
No significant inflammation or irritation of the skin of the upper extremities that is not clinically diagnosed as sun damage or AK
Patients must agree to limit sun exposure as much as possible and may continue their normal pattern of sunscreen use

PATIENT CHARACTERISTICS:

Inclusion criteria:

Females must not be of childbearing potential, and therefore must be post-menopausal or surgically sterile by hysterectomy
Not pregnant or nursing

Exclusion criteria:

Concurrent skin malignancy or disorder of the upper extremities

Patients with Squamous cell carcinoma or basal cell carcinoma in an area other than the test area are eligible upon excision of the Squamous cell carcinoma or basal cell carcinoma
Patients who are immunosuppressed by virtue of medication or disease
Serious concurrent illness that could interfere with study regimen
Invasive cancer within the past 5 years

PRIOR CONCURRENT THERAPY:

At least 30 days since prior topical medications to the skin of the upper extremities except for emollients or sunscreens

At least 30 days since prior and no concurrent mega-doses of vitamins, defined as any of the following:

More than 5 times the recommended daily allowance
More than 5 capsules of multivitamins
400 IU of vitamin E
200 μg of selenium
1 gm of vitamin C

At least 6 months since prior and no concurrent therapy for squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) anywhere in the test area (i.e., the forearms or hands)

Treatment for Squamous cell carcinoma or basal cell carcinoma on sites other than the test area is allowed
At least 4 weeks since prior surgical biopsy, surgical excision, or cryotherapy for AK in the test area and the sites must have healed
At least 6 months since prior topical treatment (e.g., 5-fluorouracil or imiquimod) for AK
No concurrent therapy that may interfere with clinical evaluations
No concurrent topical drug treatment (e.g., retinoids, aminolevulinic acid, diclofenac sodium, imiquimod, or fluorouracil) to any area of skin, including test area
No concurrent enrollment in another clinical trial
No concurrent topical citrus peel or consumption of citrus peel
No chemotherapy for cancer within the past 5 years
Intervention: Perillyl alcohol
Trial phase: Phase 2
SMILES: C=C(C)C1CC=C(CO)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Resident of Pima or adjoining Southern Arizona county

Patients outside of Pima County are also eligible

Sun damaged skin as judged by the study physician and quantifiable, clinically diagnosed, and visible actinic keratoses (AK) on both dorsal forearms, with at least two AK on each arm

AK lesions must not be clustered, confluent, or too numerous to count accurately
Presence of AK on sites other than the test area allowed
No significant inflammation or irritation of the skin of the upper extremities that is not clinically diagnosed as sun damage or AK
Patients must agree to limit sun exposure as much as possible and may continue their normal pattern of sunscreen use

PATIENT CHARACTERISTICS:

Inclusion criteria:

Females must not be of childbearing potential, and therefore must be post-menopausal or surgically sterile by hysterectomy
Not pregnant or nursing

Exclusion criteria:

Concurrent skin malignancy or disorder of the upper extremities

Patients with Squamous cell carcinoma or basal cell carcinoma in an area other than the test area are eligible upon excision of the Squamous cell carcinoma or basal cell carcinoma
Patients who are immunosuppressed by virtue of medication or disease
Serious concurrent illness that could interfere with study regimen
Invasive cancer within the past 5 years

PRIOR CONCURRENT THERAPY:

At least 30 days since prior topical medications to the skin of the upper extremities except for emollients or sunscreens

At least 30 days since prior and no concurrent mega-doses of vitamins, defined as any of the following:

More than 5 times the recommended daily allowance
More than 5 capsules of multivitamins
400 IU of vitamin E
200 μg of selenium
1 gm of vitamin C

At least 6 months since prior and no concurrent therapy for squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) anywhere in the test area (i.e., the forearms or hands)

Treatment for Squamous cell carcinoma or basal cell carcinoma on sites other than the test area is allowed
At least 4 weeks since prior surgical biopsy, surgical excision, or cryotherapy for AK in the test area and the sites must have healed
At least 6 months since prior topical treatment (e.g., 5-fluorouracil or imiquimod) for AK
No concurrent therapy that may interfere with clinical evaluations
No concurrent topical drug treatment (e.g., retinoids, aminolevulinic acid, diclofenac sodium, imiquimod, or fluorouracil) to any area of skin, including test area
No concurrent enrollment in another clinical trial
No concurrent topical citrus peel or consumption of citrus peel
No chemotherapy for cancer within the past 5 years
Intervention: Gefitinib
Trial phase: Phase 4
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: gefitinib tablet 250 mg orally
Eligibility criteria:
Inclusion Criteria:

Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma
Previously failed the first-line chemotherapy
Patient who can provide sample for EGFR mutation test

Exclusion Criteria:

Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation
Any evidence of clinically active interstitial lung disease
Intervention: Ubidecarenone
Trial phase: Phase 3
ATC code: C01EB09
SMILES: COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 303
Group description: Randomized to active treatment (coenzyme Q10 2400 mg/day)

coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day
Eligibility criteria:
Inclusion Criteria:

To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization:

Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36.
TFC > 9.
Must be ambulatory and not require skilled nursing care.
Age ≥ 16 years.
Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study).
If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. (Note: stable dosing of tetrabenazine is allowable.) Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial.
Able to give informed consent and comply with trial procedures
Able to take oral medication.
May be required to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home.
A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study.

Exclusion Criteria:

History or known sensitivity of intolerability to CoQ.
Exposure to any investigational drug within 30 days of the Baseline visit.
Clinical evidence of unstable medical illness in the investigator's judgment.
Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.
Substance (alcohol or drug) abuse within one year of the Baseline visit.
Women who are pregnant or breastfeeding.
Use of supplemental coenzyme Q10 within 30 days prior to the Baseline visit
Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of <100,000/ul, hematocrit level of <33 for female or <35 for male, or coagulation tests > 1.5 time upper limit of normal).
Known allergy to FD&C yellow #5 or any other ingredient in the study drug (active and placebo)
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
Eligibility criteria:
Inclusion Criteria:

Male or female patients
Aged 15 to 65 years
Patients with a diagnosis of epilepsy for which they are either taking up two AEDs, not including VPA/divalproex, or no AEDs
Patients with a reproducible IPS-induced photo-paroxysmal responses of at least 7 SPR-EEG units as measured at two different time points in the day (pm screening Study Visit 1 and am of Visit 2).
Are in good health (with the exception of epilepsy).
Able and willing to provide written informed consent.

Exclusion Criteria:

Patients not exhibiting a photo-paroxysmal-EEG response
Patients with active psychogenic seizures
Women who are pregnant or lactating
Women of reproductive potential who do not agree to use effective birth-control methods during the study and for one week after receiving study drug.
Patients taking any dosage form of VPA/divalproex within 4 weeks prior to the study
Patients taking more than two concomitant AEDs
Patients with any clinically significant laboratory abnormality, which in the opinion of the investigator, will exclude the patient from the study
Patients who are suffering from active liver disease indicated by abnormal liver function tests greater than three times the upper limit of normal (AST and ALT), patients with porphyria, or patients with a family history of severe hepatic dysfunction
Patients with a history of alcoholism, drug abuse, or drug addiction (within the past 12 months)
Patients with a history of sensitivity or allergic reaction to valproate / divalproex
Patients who have a medical history which would contraindicate sodium valproate (VPA) administration
Patients who have participated in any other trials involving an investigational product or device within 30 days of screening.
Patients with clinically significant ECG abnormalities, as judged by the PI, at screening visit
Patients with such poor intravenous access that the insertion of two intravenous catheters (one for sodium valproate infusion and one, in a contralateral arm vein, for serial blood sampling) for a 12-hour period is not possible.
Patients who received benzodiazepines within one week of study initiation
Status epilepticus within one year of screening
Generalized tonic-clonic seizure within 24 hours of photic stimulation procedure
Intervention: Rosiglitazone
Trial phase: Phase 2
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women age 60-75 with no rosiglitazone allergy

Exclusion Criteria:

Osteoporosis
Diabetes
Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism
Treatment with bone active drugs
Low impact fracture
Heart disease
Kidney failure
Liver failure
Anaemia
Ineligibility for MRI-scan
Cancer within last 5 years
Intervention: Insulin
Trial phase: Not Applicable
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: 44
Group description: The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
Eligibility criteria:
Inclusion Criteria:

18 years of age and greater,
Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG >100 mg/dL per admission screening labs, random BG >120mg/dL per admission screening labs, and
Willing and able to provide informed consent

Exclusion Criteria:

History of an active GI bleed in the previous 3 mos,
Scheduled to receive a simultaneous pancreas transplant,
History of a functioning pancreatic transplant,
Patient currently managed on an insulin pump,
Unable or unwilling to provide informed consent, and
Unable to commit to the study protocol including the outpatient follow-up phase of care
Intervention: Phenytoin
Trial phase: Phase 4
ATC code: N03AB02 | N03AB52
SMILES: O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: intravenous phenytoin alone
Eligibility criteria:
Inclusion Criteria:

Men with pharmacoresistant partial epilepsy defined as failure of two or more AEDs at a reasonable therapeutic dose
Patient is able to understand and sign a consent form and able to keep a seizure calendar
Patient is older than 18 years of age
Patient is otherwise healthy by laboratory and physical examination

Exclusion Criteria:

Patient is currently taking phenytoin
Patient has a history of an adverse reaction to phenytoin
Patient has a history of gout disease, peptic ulcer disease, blood dyscrasias, or uric acid kidney stones
Patient has an allergy to sulfa drugs or probenecid
Patient has been exposed to probenecid or another known transporter inhibitor (verapamil, progesterone, etc) in the three months prior to enrollment
Patient has a history of renal impairment (creatinine clearance < 50 ml/min)
Patient has a history of diabetes and is taking oral sulfonylurea agents
Intervention: (3S)-3,4-Propano-2,3-dihydropyrido[3,2-f][1,4]oxazepine-5(4H)-one
Trial phase: Phase 2
SMILES: O=C1c2cccnc2OCC2CCCN12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
Eligibility criteria:
Inclusion Criteria:

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Exclusion Criteria:

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
donation of blood within 60 days prior to the anticipated first dose of trial medication.
Intervention: (3S)-3,4-Propano-2,3-dihydropyrido[3,2-f][1,4]oxazepine-5(4H)-one
Trial phase: Phase 2
SMILES: O=C1c2cccnc2OCC2CCCN12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
Eligibility criteria:
Inclusion Criteria:

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Exclusion Criteria:

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
donation of blood within 60 days prior to the anticipated first dose of trial medication.