anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Minocycline
Trial phase: Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Minocycline 100 mg twice a day during standard of care chemoradiation therapy plus additional follow up for 5 weeks, for a total of 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients with a pathologically proven diagnosis of NSCLC and consented to receive CXRT at MD Anderson
Patients > or = 18 years old
Patients who will receive CXRT with platinum/taxane-based chemotherapy and with a total radiation dose of >or = 50 Gy, per treating physician's assessment
Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol)
Patients willing and able to review, understand, and provide written consent before starting therapy
Patients with normal renal function according to MD Anderson testing standards and no prior renal disease [screening cut off for serum creatinine < 1.5 times ULN]
Patients must have the following screening results for hepatic function according to MD Anderson testing standards: total bilirubin < 1.5 times the upper limit of normal; alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST - if available) must be < 2 times the upper limit of normal

Exclusion Criteria:

Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records
Patients who are enrolled in other symptom management or symptom clinical trials
Patients who currently have bile duct obstruction or cholelithiasis
Patients with hypersensitivity to any tetracyclines
Patients who are pregnant; pregnancy will be confirmed by negative urine test
Patients on vitamin K antagonist warfarin
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.

Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
Eligibility criteria:
Inclusion Criteria:

OIF/OEF veteran
Between the ages of 18 and 50 years old
Not taking medications known to affect sleep or wake function for 2 weeks

Additional selection criteria for PTSD subjects are:

Trauma occurred three months or more before study entry
Meeting diagnostic criteria for current PTSD according to the Clinician Administered PTSD Scale (CAPS)
Participants will remain in ongoing counseling services

Additional selection criterion for non-PTSD healthy subjects:

Not meet DSM-IV diagnostic criteria for current PTSD
Have a total score < 13 on the Beck Depression Inventory
Participants who are active-duty military personnel will be required to obtain permission from their commander to participate in this study.

Exclusion Criteria:

Current diagnosis of untreated, severe depression as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual- IV Edition (DSM-IV), non-patient version
Beck Depression Inventory > 30
History of psychotic or bipolar disorder
Current history (within 3 months) of substance or alcohol abuse
Significant or unstable acute or chronic medical conditions
Other current sleep disorders
Presence of implanted devices or metal in body such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
Fear of closed spaces
Previous radiation exposure (past year) that exceeds recommended safety limits
Pregnancy or breast feeding
Resting blood pressure < 90/60 at the screening physical examination
Heart rate > 100 beats/minutes
Current use of a beta-blocker
Use of an alpha-1 antagonist agent in the previous 3 weeks
Refusal to follow the safety measures in the case of use of a phosphodiesterase 5 inhibitor (Cialis, Viagra, Levitra)
Unexpected, untreated, or serious EKG findings
Intervention: Losartan
Trial phase: Phase 2
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.

Losartan: Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic.
Eligibility criteria:
Inclusion Criteria:

Males and females between ages of 21 and 65 years
Apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour
Subjects eligible for CPAP or BiPAP therapy
Hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure > 140/90 mm Hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening)

Exclusion Criteria:

If subject not using CPAP, having AHI > 60 events/hour or oxygen saturation ≤ 65% during sleep
Presence of clinical CV disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by PI for enrollment), stroke, TIA, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history
Presence of pulmonary disease that results in significant hypoxemia (resting SaO2 < 88%)
Hypertriglyceridemia (triglycerides >300 mg/dL), diabetes or impaired glucose tolerance (fasting plasma glucose > 125 mg/dL)
Patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine.
Patients with chronic kidney disease (Serum creatinine >1.5 mg/dL) or history of significant hyperkalemia (Serum potassium > 5.2 mEq/L) with ARB therapy
Patients with history of angioedema
Patients with bilateral,modified radical or radical mastectomies
Patients who have a Serum potassium > 5.0 mEq/L at the screening visit
Female patients who are pregnant (determined by urine pregnancy test) or breastfeeding
Patients with active MRSA or VRE (vancomycin resistant enterococcus) infection
History of adverse reaction to allopurinol,losartan, or zolpidem**
Patients who cannot swallow oral capsules
Patients who are hospitalized or who have been recently hospitalized (last 2 weeks)
Inability to comply with or complete the protocol or other reasons at the discretion of the investigators
Intervention: Allopurinol
Trial phase: Phase 2
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Allopurinol 300 mg daily for 6 weeks

Allopurinol: Allopurinol 300 mg daily for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Males and females between ages of 21 and 65 years
Apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour
Subjects eligible for CPAP or BiPAP therapy
Hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure > 140/90 mm Hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening)

Exclusion Criteria:

If subject not using CPAP, having AHI > 60 events/hour or oxygen saturation ≤ 65% during sleep
Presence of clinical CV disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by PI for enrollment), stroke, TIA, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history
Presence of pulmonary disease that results in significant hypoxemia (resting SaO2 < 88%)
Hypertriglyceridemia (triglycerides >300 mg/dL), diabetes or impaired glucose tolerance (fasting plasma glucose > 125 mg/dL)
Patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine.
Patients with chronic kidney disease (Serum creatinine >1.5 mg/dL) or history of significant hyperkalemia (Serum potassium > 5.2 mEq/L) with ARB therapy
Patients with history of angioedema
Patients with bilateral,modified radical or radical mastectomies
Patients who have a Serum potassium > 5.0 mEq/L at the screening visit
Female patients who are pregnant (determined by urine pregnancy test) or breastfeeding
Patients with active MRSA or VRE (vancomycin resistant enterococcus) infection
History of adverse reaction to allopurinol,losartan, or zolpidem**
Patients who cannot swallow oral capsules
Patients who are hospitalized or who have been recently hospitalized (last 2 weeks)
Inability to comply with or complete the protocol or other reasons at the discretion of the investigators
Intervention: Faldaprevir
Trial phase: Phase 1
ATC code: J05AP04
SMILES: C=CC1CC1(NC(=O)C1CC(Oc2cc(-c3csc(NC(=O)C(C)C)n3)nc3c(Br)c(OC)ccc23)CN1C(=O)C(NC(=O)OC1CCCC1)C(C)(C)C)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.
Eligibility criteria:
Inclusion criteria:

stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
Male and female volunteers with a body mass index (BMI) = 18.5 and < 32 with a minimum weight of 50kg.

Exclusion criteria:

any other significant medical illness of clinical significance.
history of rash or photosensitivity
chronic or acute infections including HIV, hepatitis B and hepatitis C.
history of allergy considered significant for this study
intake of any other medications except for methadone or buprenorphine/naloxone.
QTc on electrocardiogram (ECG) > 470.
use of any other investigational drug within 30 days of the study.
drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)
blood donation of more than 100mL within four weeks of the trial.
excessive physical activities one week prior to and during the trial.
any clinically relevant laboratory value.
concomitant use of any food product known to alter P450 or P-gp activity such as grapefruit juice, seville oranges and St. John's Wort.

inadequate venous access

For women of childbearing potential:

pregnancy or planning to become pregnant within 3 months of the trial
positive pregnancy test at screening visit
no proof of sterilization or unwilling or unable to use a double barrier method of birth control during the study and up to 3 months after the study.
lactation with active breastfeeding from screening up to 30 days after last study visit.
Intervention: Mirabegron
Trial phase: Phase 3
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 936
Group description: Participants who received mirabegron 50 mg once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly
Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
Subject has neurogenic bladder
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
Subject has an indwelling catheter or practices intermittent self-catheterization
Subject has diabetic neuropathy
Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
Subject has moderate to severe hepatic impairment
Subject has severe renal impairment or end stage renal disease
Subject has severe uncontrolled hypertension
Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
Subject's last antimuscarinic treatment was solifenacin
Intervention: Solifenacin Succinate
Trial phase: Phase 3
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 934
Group description: Participants who received solifenacin 5 mg once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly
Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
Subject has neurogenic bladder
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
Subject has an indwelling catheter or practices intermittent self-catheterization
Subject has diabetic neuropathy
Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
Subject has moderate to severe hepatic impairment
Subject has severe renal impairment or end stage renal disease
Subject has severe uncontrolled hypertension
Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
Subject's last antimuscarinic treatment was solifenacin
Intervention: Peficitinib
Trial phase: Phase 3
ATC code: L04AA49 | L04AF06
SMILES: NC(=O)c1cnc2[nH]ccc2c1N[C@@H]1[C@@H]2CC3C[C@H]1C[C@@](O)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Eligibility criteria:
Inclusion Criteria:

Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.
Intervention: Peficitinib
Trial phase: Phase 3
ATC code: L04AA49 | L04AF06
SMILES: NC(=O)c1cnc2[nH]ccc2c1N[C@@H]1[C@@H]2CC3C[C@H]1C[C@@](O)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Eligibility criteria:
Inclusion Criteria:

Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.
Intervention: Peficitinib
Trial phase: Phase 3
ATC code: L04AA49 | L04AF06
SMILES: NC(=O)c1cnc2[nH]ccc2c1N[C@@H]1[C@@H]2CC3C[C@H]1C[C@@](O)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 417
Group description: Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Eligibility criteria:
Inclusion Criteria:

Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.