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: 23
Group description: Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Minocycline: 100 mg by mouth two times a day (200 mg/day).

Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Eligibility criteria:
Inclusion Criteria:

Minocycline Trial only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy.
Observational Arm only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy.
Patients > 18 years old.
Minocycline Trial only: Patients with ECOG PS = 0-2.
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.
Minocycline Trial only: Patients with adequate renal function according to MD Anderson testing standards (screening cut off for serum creatinine < 2 times the upper limit of normal).
Minocycline Trial only: Patients with adequate hepatic function according to MD Anderson testing standards (screening results for total bilirubin must be < 2 times the upper limit of normal; screening results for alanine aminotransferase (ALT) must be < 3 times the upper limit of normal; screening results for aspartate aminotransferase (AST), if available, must be < 3 times the upper limit of normal).

Exclusion Criteria:

Minocycline Trial only: Patients who are taking medication or have conditions that potentially preclude use of minocycline, as determined by the treating physician.
Patients who are enrolled in other symptom management clinical trials.
Minocycline Trial only: Patients who currently have bile duct obstruction or cholelithiasis.
Minocycline Trial only: Patients with hypersensitivity to any tetracyclines.
Minocycline Trial only: Patients who are pregnant. Pregnancy will be confirmed by negative urine test; patients with a positive urine test will be retested for doubling of HCG 48 hours after the first test, because of beta-HCG's role as a tumor marker. Patients without such a rise will be eligible for the study and will be enrolled at the investigator's discretion.
Minocycline Trial only: Patients who are under treatment of warfarin with INR > 1.5.
Patients who, in the judgment of the investigator, may be unable to participate in the required study procedures.
Minocycline Trial only: Patients who have had prior treatment for pancreatic cancer within the past six months may be excluded at the discretion of the investigator.
Intervention: Zosyn
Trial phase: Phase 4
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day

Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion
Eligibility criteria:
Inclusion Criteria:

Diagnosis of cystic fibrosis
8 years of age or greater
Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
Pulmonary exacerbation as defined by Fuchs et al.

Exclusion Criteria:

Admission for greater than 48 hours prior to enrollment
Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
Current treatment for allergic bronchopulmonary aspergillosis
Pregnant or breast feeding
History of solid organ transplantation
Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis
Allergy to study medication
Intervention: Zosyn
Trial phase: Phase 4
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily

Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion
Eligibility criteria:
Inclusion Criteria:

Diagnosis of cystic fibrosis
8 years of age or greater
Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
Pulmonary exacerbation as defined by Fuchs et al.

Exclusion Criteria:

Admission for greater than 48 hours prior to enrollment
Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
Current treatment for allergic bronchopulmonary aspergillosis
Pregnant or breast feeding
History of solid organ transplantation
Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis
Allergy to study medication
Intervention: Acetylcarnitine
Trial phase: Phase 4
ATC code: N06BX12
SMILES: CC(=O)OC(CC(=O)[O-])C[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Acetyl-L-carnitine tablets

Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65 years
Signed informed consent
Migraine with or without aura according to International Classification of Headache Disorders, second version (ICHD-2) criteria
chronic migraine according to the ICHD-2 criteria (revision 1)
Retrospectively have 2 or more migraine attacks per month during the last 3 month
During the baseline period have 2 or more migraine attacks
Debut of migraine at least one year prior to inclusion
Start of migraine before age 50 years
Body mass index (BMI )between 18-35 kg/m2
No medication overuse during the last 3 months defined as headache >14 days/month combined with overuse simple analgesics >14 days/month or triptans or combined medications ≥ 10 days/month.

Exclusion Criteria:

Interval headache not distinguishable from migraine
Chronic tension-type headache or other headache than migraine occurring on ≥ 15 days/month with or without medication overuse
Pregnancy, nursing or inability to use contraceptives
Hypersensitivity to active substance
History of angioneurotic edema, diabetes mellitus, significant psychiatric illness and/or Hospital anxiety and Depression Scale( HADS) anxiety score ≥ 11 or HADS depression score ≥ 11, and/or use of selective serotonin reuptake inhibitors (SSRI), antipsychotic medication, or antidepressant medication during the last 3 months
Use of daily migraine prophylactics less than 3 months prior to start of study
Previous use of Acetyl-L-carnitine
BMI <18 kg/m2 or BMI > 35 kg/m2
Having tried ≥ 3 prophylactic drugs against migraine during the last 5 years
Subjects requiring detoxification from acute medication
Patients who consistently fail to respond to any acute migraine medication
Patients with alcohol or illicit drug dependence; 13) Subjects with renal disease or decreased renal function
Previous or present history of asthma or vascular disease, arterial claudication included.
Intervention: Acetylcarnitine
Trial phase: Phase 4
ATC code: N06BX12
SMILES: CC(=O)OC(CC(=O)[O-])C[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Glucose with lemon acid

Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g):
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65 years
Signed informed consent
Migraine with or without aura according to International Classification of Headache Disorders, second version (ICHD-2) criteria
chronic migraine according to the ICHD-2 criteria (revision 1)
Retrospectively have 2 or more migraine attacks per month during the last 3 month
During the baseline period have 2 or more migraine attacks
Debut of migraine at least one year prior to inclusion
Start of migraine before age 50 years
Body mass index (BMI )between 18-35 kg/m2
No medication overuse during the last 3 months defined as headache >14 days/month combined with overuse simple analgesics >14 days/month or triptans or combined medications ≥ 10 days/month.

Exclusion Criteria:

Interval headache not distinguishable from migraine
Chronic tension-type headache or other headache than migraine occurring on ≥ 15 days/month with or without medication overuse
Pregnancy, nursing or inability to use contraceptives
Hypersensitivity to active substance
History of angioneurotic edema, diabetes mellitus, significant psychiatric illness and/or Hospital anxiety and Depression Scale( HADS) anxiety score ≥ 11 or HADS depression score ≥ 11, and/or use of selective serotonin reuptake inhibitors (SSRI), antipsychotic medication, or antidepressant medication during the last 3 months
Use of daily migraine prophylactics less than 3 months prior to start of study
Previous use of Acetyl-L-carnitine
BMI <18 kg/m2 or BMI > 35 kg/m2
Having tried ≥ 3 prophylactic drugs against migraine during the last 5 years
Subjects requiring detoxification from acute medication
Patients who consistently fail to respond to any acute migraine medication
Patients with alcohol or illicit drug dependence; 13) Subjects with renal disease or decreased renal function
Previous or present history of asthma or vascular disease, arterial claudication included.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Not Applicable
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Loteprednol Etabonate 0.5%

Lotemax
Eligibility criteria:
Inclusion Criteria:

Scheduled for allogenic bone marrow transplant

Exclusion Criteria:

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Intervention: Cyclosporine
Trial phase: Not Applicable
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Cyclosporine

Restasis
Eligibility criteria:
Inclusion Criteria:

Scheduled for allogenic bone marrow transplant

Exclusion Criteria:

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Intervention: Ipratropium
Trial phase: Phase 4
ATC code: R01AX03 | R03AL01 | R03AL02 | R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.

Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
Eligibility criteria:
Inclusion Criteria:

Gender and Age:
Males and females, ages 18- 50

Current Smoker:

Smoke at least 5 cigarettes per day for at least 5 years
Positive urine cotinine test

Asthma:

Physician diagnosed asthma

Symptomatic, as evidenced by

Use of SABA two or more times per week for relief of asthma symptoms, or
One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.
Pre-BD FEV1 greater than or equal to 40% predicted

Asthma diagnosis confirmed by either

albuterol reversibility of FEV1 by 12% or more, or
20% fall in FEV1 at 8mg or less of methacholine
If over age 45, a DLco greater than 80% predicted
Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria:

Diagnosis of COPD or emphysema

Other major chronic illnesses in the opinion of the investigator that might interfere with the study:

- e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.

Recent active substance abuse (in past 6 months)
Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease
Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).

High risk of near fatal or fatal asthma as defined by the following 1-3

ICU admission of asthma in the past year
more than 2 hospitalizations for asthma in the previous year
more than 3 ED visits for asthma in the previous year
intubation or ICU admission for asthma in the past 2 years
use of more than 2 canisters of inhaled short-acting beta2-agonist in past month
Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.

Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Gender and Age:
Males and females, ages 18- 50

Current Smoker:

Smoke at least 5 cigarettes per day for at least 5 years
Positive urine cotinine test

Asthma:

Physician diagnosed asthma

Symptomatic, as evidenced by

Use of SABA two or more times per week for relief of asthma symptoms, or
One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.
Pre-BD FEV1 greater than or equal to 40% predicted

Asthma diagnosis confirmed by either

albuterol reversibility of FEV1 by 12% or more, or
20% fall in FEV1 at 8mg or less of methacholine
If over age 45, a DLco greater than 80% predicted
Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria:

Diagnosis of COPD or emphysema

Other major chronic illnesses in the opinion of the investigator that might interfere with the study:

- e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.

Recent active substance abuse (in past 6 months)
Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease
Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).

High risk of near fatal or fatal asthma as defined by the following 1-3

ICU admission of asthma in the past year
more than 2 hospitalizations for asthma in the previous year
more than 3 ED visits for asthma in the previous year
intubation or ICU admission for asthma in the past 2 years
use of more than 2 canisters of inhaled short-acting beta2-agonist in past month
Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)
Intervention: Bevenopran
Trial phase: Phase 3
SMILES: COc1cc(CNCCC2CCOCC2)ccc1Oc1cnc(C(N)=O)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 703
Group description: 0.25 mg CB-5945, administered orally, BID for 52 weeks
Eligibility criteria:
Inclusion Criteria:

Is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
Has constipation that is caused by the chronic use of opioids
Is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (for example, lubiprostone) during the study period (from Screening until the last study assessment).
Is able and willing to refrain from facilitating defecation via manual maneuvers (for example, digital evacuation or support of the pelvic floor) during the study period (from Screening to the last study assessment)

Exclusion Criteria:

Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction
Has evidence of intestinal obstruction
Has a history of rectal bleeding not due to hemorrhoids or fissures
Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
Is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example, loperamide), prokinetics (for example, metoclopramide), or locally acting chloride channel activators (for example, lubiprostone)
Is taking non-opioid medications known to cause constipation (for example, iron sulfate therapy or tricyclic antidepressants)
Intervention: Testosterone
Trial phase: Early Phase 1
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
Eligibility criteria:
Inclusion Criteria:

Women with breast cancer
Currently taking an aromatase inhibitor (AI)
Age > 50 years of age
Postmenopausal, or two years since last menstrual cycle
Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse
Changes in sexual health quality of life/sexual functioning since starting AI therapy

Exclusion Criteria:

The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
A known sensitivity to medications containing testosterone
The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 67
Group description: BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Informed consent/(assent - if applicable)
Male or female subjects 6-11 years of age
General good health
A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
Other criteria apply

Exclusion Criteria:

Pregnancy, nursing, or plans to become pregnant or donate gametes
Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
Previous participation in a BDP nasal aerosol study as a randomized subject
A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
Other criteria apply
Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year