anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Vancomycin
Trial phase: Phase 2
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1037
Group description: During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water

Vancomycin: Topical prophylactic antibiotic
Eligibility criteria:
Inclusion Criteria:

Able to sign Informed Consent and Release of Medical Information Form
Age ≥ 18 years
Undergoing cardiac surgery with complete sternotomy (including re-operations)

Exclusion Criteria:

Evidence of active infection (any culture positive or blood positive infection)
Undergoing organ transplantation
Patients with known hypersensitivity to vancomycin
Pregnant or nursing women
Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
Intervention: Rivaroxaban
Trial phase: Phase 4
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)

rivaroxaban
Eligibility criteria:
Key Inclusion Criteria:

Eligible patients with atrial fibrillation at enrollment or two or more episodes of atrial fibrillation or flutter, as documented by electrocardiography, at least 2 weeks apart in the 12 months before enrollment
Age 18-84
On Warfarin for 6 months prior to enrollment at a stable dose.
Willingness to participate in the study and ability to sign informed consent
Minimum CAC score of 10

Key Exclusion Criteria:

Atrial fibrillation due to a reversible cause, moderate or severe mitral stenosis, or conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)
Prior apixaban, dabigatran, rivaroxaban use.
A need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel,
Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute).
Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active peptic ulcer disease, a platelet count of <100,000/mm3 or hemoglobin level of <10 g/dL, stroke within the previous 10 days, documented hemorrhagic tendencies, or blood dyscrasias)
Weight in excess of 325 pounds
Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg).
History of active malignancy requiring concurrent chemotherapy.
Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the principal investigator is likely to affect the subject's ability to complete the study.
Known allergy to iodinated contrast material
Pregnancy or breast feeding
Intervention: Warfarin
Trial phase: Phase 4
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: warfarin orally once a day, titrated to INR of 2-3

Warfarin
Eligibility criteria:
Key Inclusion Criteria:

Eligible patients with atrial fibrillation at enrollment or two or more episodes of atrial fibrillation or flutter, as documented by electrocardiography, at least 2 weeks apart in the 12 months before enrollment
Age 18-84
On Warfarin for 6 months prior to enrollment at a stable dose.
Willingness to participate in the study and ability to sign informed consent
Minimum CAC score of 10

Key Exclusion Criteria:

Atrial fibrillation due to a reversible cause, moderate or severe mitral stenosis, or conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)
Prior apixaban, dabigatran, rivaroxaban use.
A need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel,
Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute).
Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active peptic ulcer disease, a platelet count of <100,000/mm3 or hemoglobin level of <10 g/dL, stroke within the previous 10 days, documented hemorrhagic tendencies, or blood dyscrasias)
Weight in excess of 325 pounds
Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg).
History of active malignancy requiring concurrent chemotherapy.
Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the principal investigator is likely to affect the subject's ability to complete the study.
Known allergy to iodinated contrast material
Pregnancy or breast feeding
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: N-acetylcysteine

N-acetylcysteine
Eligibility criteria:
Inclusion Criteria:

Cold/URTI symptoms occurring no more than 4 days
cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
cough frequency with specified cut-off

Exclusion Criteria:

A subchronic, or chronic cough (cough duration > 2 months) due to any condition other than a cold/URTI
Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
Taking any medications known to induce cough
Fever of greater than 39°C (102°F) orally
Complication of the common cold like otitis media, severe sinusitis, or pneumonia
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Alvimopan
Trial phase: Not Applicable
ATC code: A06AH02
SMILES: C[C@H]1CN(C[C@H](Cc2ccccc2)C(=O)NCC(=O)O)CC[C@@]1(C)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.
Eligibility criteria:
Inclusion Criteria:

Subjects will be informed about the study, have read, understood, and signed the Informed Consent Form
Subjects of either gender that are ≥18 years of age
Subjects who can ambulate preoperatively
Subjects will have a Body-Mass Index (BMI) of ≤ 40mg/m2
Subjects with an American Society of Anesthesiologists (ASA) classification of 1, 2 or 3
Subjects not receiving an epidural to control perioperative pain
Subjects will be undergoing elective single-staged open ventral (incisional or midline) hernia repair
Subjects in which intra-operatively their surgical field/wound is characterized as Type 1 (Appendix II)
Subjects with a hernia defect ≥9 cm2 large

Exclusion Criteria:

Subjects who are not able to comprehend or comply with study requirements
Subjects who are pregnant
Subjects with BMI > 40
Subjects with autoimmune disorder requiring >10mg of a corticosteroid per day
Subjects with pre-existing systemic infections
Subjects with a wound-healing disorder
Subjects who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking Alvimopan
Subjects who are immunocompromised such as HIV or transplant, or receiving chemo or radiation therapy
Subjects with a hernia defect < 9cm2 large when measured intra-operatively
Subjects in which intra-operatively their surgical wound field/wound is characterized as Type 2, 3, or 4 (Appendix II)
Subjects in which the ventral incisional hernia repair requires more than one operation to reduce the hernia or to complete the hernia repair
Subjects with a hernia repair requiring an emergent procedure
Subjects in which untreated cancer was found intra-operatively
Subjects with cirrhosis or are currently being treated with dialysis
Subjects with severe hepatic impairment (Childs-Pugh class C)
Subjects with end-stage renal disease
Subjects scheduled for a concomitant procedure that involves the GI tract
Subjects with unplanned procedures that involve the GI tract
Subjects requiring post-operative NGT
Subjects participating in another prospective interventional study that involves the use of a device, drug, or surgery that would compromise the current study
Subjects with an epidural to control perioperative pain
Intervention: Oraqix
Trial phase: Phase 2
SMILES: CCCNC(C)C(=O)Nc1ccccc1C.CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: 4 mL of lidocaine-prilocaine cream

lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
Eligibility criteria:
Inclusion Criteria:

Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
Read and speak the English language

Exclusion Criteria:

Non-English speaking
Allergy or contraindication to topical anesthetic
Participation/randomization in the study at a previous visit
Currently pregnant or lactating or planning a pregnancy within the next 6 months
Intervention: TAK-448
Trial phase: Phase 2
SMILES: [H][C@@]1(C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C(=O)NNC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)NC)C(=O)N[C@@H](Cc2c[nH]c3ccccc23)C(N)=O)[C@@H](C)O)C[C@@H](O)CN1C(=O)[C@@H](Cc1ccc(O)cc1)NC(C)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
Eligibility criteria:
Inclusion Criteria:

Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.

Exclusion Criteria:

Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on:

Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.
Is receiving dialysis treatment.
Has an American Urological Association (AUA)/ International Prostate Symptom Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram per milliliter (ng/mL) at Screening.
Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units per liter (mIU/L) at Screening.
Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood pressure >100 mm Hg (if out of range may be repeated once for eligibility determination) at Screening.
Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.
Is receiving insulin therapy.
Has a hematocrit <30 percent (%) or >48% at Screening.
Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).
Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or prior pituitary surgery.
Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening.
Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening.
Intervention: CARBON DIOXIDE
Trial phase: Phase 2
ATC code: V03AN02
SMILES: O=C=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).

Nasal Carbon Dioxide
Eligibility criteria:
Inclusion Criteria:

Male and female, 18 years of age and older.
History of episodic cluster headache, as defined by International Classification of Headache Disorders (ICHD), third edition, beta version guidelines (ICHD-3 beta, Cephalalgia 2013).
History of cluster headache attack-free remission periods lasting > 1 month within the previous year.
Stable on medications, including those for the treatment of cluster headache prevention/prophylaxis, for at least 60 days prior to baseline (including, but not limited to, verapamil, lithium, melatonin, any anticonvulsant, any systemic corticosteroid or steroid injection, occipital nerve block, other cranial or extracranial nerve block, or any neurostimulation treatment).

Note: Subjects are allowed to use their usual standard of care for the acute/abortive treatment of acute cluster attacks 60 or more minutes after the initial dose, limited to the following: triptans; high-flow oxygen.

If female and of childbearing potential, have a negative urine pregnancy test at the time of Screening.

a. To not be considered childbearing potential a subject must be surgically sterile, have had a hysterectomy or tubal ligation, post-menopausal for at least 1 year, or otherwise incapable of pregnancy.

Capable of completing online headache diary with access to internet.
Able to provide written Informed Consent.

Exclusion Criteria:

Recent nasal/midface trauma (< 3 months)
Recent nasal/sinus surgery (< 3 months).
Severe respiratory distress in the last 6 months.
Neoplasm such as Angiofibroma, sinus tumor, granuloma.
Nasal congestion present more than 10 days with fever (temperature ≥ 100.4 °F) and nasal mucous is an abnormal color.
Surgery to treat cluster headache.
History of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
Structural intracranial or cervical vascular lesions that may potentially cause headache attacks.
Other significant pain problems (including cancer pain, fibromyalgia, and trigeminal neuralgia) that might confound the study assessments in the investigator opinion.
Psychiatric disorder, which in the opinion of the Investigator, may interfere with the study.
Pregnant, actively trying to become pregnant, or breastfeeding, and/or is unwilling to use an accepted form of birth control.
Skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding.
Recurrent nose bleeds, which in the opinion of the Investigator, may interfere with the study.
Is participating in any other therapeutic clinical investigation or has participated in a clinical trial and received treatment in the preceding 30 days.
Intervention: Ganciclovir
Trial phase: Phase 2
ATC code: J05AB06 | S01AD09
SMILES: Nc1nc2c(ncn2COC(CO)CO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.

gancyclovir gel: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.
Eligibility criteria:
Inclusion Criteria:

age 18 and above
have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month
able and willing to attend subsequent follow-up visits

Exclusion Criteria:

Associated retinitis
patients who are allergic to gancyclovir
patients who will require systemic or intra-vitreal gancyclovir therapy
patients who are pregnant or breastfeeding
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.

Hypromellose gel: 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.
Eligibility criteria:
Inclusion Criteria:

age 18 and above
have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month
able and willing to attend subsequent follow-up visits

Exclusion Criteria:

Associated retinitis
patients who are allergic to gancyclovir
patients who will require systemic or intra-vitreal gancyclovir therapy
patients who are pregnant or breastfeeding
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
Eligibility criteria:
Inclusion Criteria:

Age 18-45
Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD

Exclusion Criteria:

Restless leg syndrome
Narcolepsy
Sleep Apnea
Neurological disorders
Pregnancy
cardiac abnormalities
significant electrolyte abnormalities
Use of steroids, beta blockers, prazosin
Alcohol/substance abuse
Intervention: SOMAPACITAN
Trial phase: Phase 3
ATC code: H01AC07
SMILES: C=C(CCCCCCCCCCCCCCCc1nnn[nH]1)NS(=O)(=O)CCCC(=O)NCCOCCOCC(=O)N[C@@H](CCC(=O)N[C@@H](CCC(=O)NCCOCCOCC(=O)N[C@@H](CCCCNC(=O)CSC[C@H](N)C(=O)O)C(N)=O)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received s.c. injections of somapacitan once-weekly for 26 weeks (8 weeks dose titration followed by 18 weeks fixed dose treatment) followed by 1 week washout. The starting dose of somapacitan was 1.5 mg/week (except females on oral oestrogen 2.0 mg/week; participants older than 60 years 1.0 mg/week). An individualised dose titration regimen was used. Adjustment of dose was performed at weeks 2, 4, 6 and 8 based on IGF-I SDS values:

IGF-I SDS > 3: dose reduction by 1 mg 2 < IGF-I SDS ≤ 3: dose reduction by 0.5 mg 0 < IGF-I SDS ≤ 2: No need for dose adjustment

2 < IGF-I SDS ≤ 0: Dose Increment by 0.7 mg IGF-I SDS ≤ -2: Dose Increment by 1.5 mg After the last dose adjustment (if any) at week 8, the individual dose level was fixed. The minimum and maximum weekly dose was set to 0.1 mg and 8 mg.
Eligibility criteria:
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - Adult growth hormone deficiency diagnosed for 6 months or longer (defined as 180 days) prior to screening - Treatment with hGH (human growth hormone) for at least 6 months at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone deficiency) attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file - For patients with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years: Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation