anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fluciclovine (18F)
Trial phase: Phase 1 | Phase 2
ATC code: V09IX12
SMILES: N[C@]1(C(=O)O)C[C@@H]([18F])C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: [18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer

[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI

[18F] fluciclovine: [18F] fluciclovine
Eligibility criteria:
Inclusion Criteria:

- High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA > 20)

Exclusion Criteria:

Inability to tolerate or undergo PET/MRI
Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
Recurrent prostate adenocarcinoma
Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI
Known allergy to glucagon or gadolinium-based contrast
Intervention: Fasoracetam
Trial phase: Phase 2
SMILES: O=C1CC[C@H](C(=O)N2CCCCC2)N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: 100 mg, 200 mg or 400 mg of AEVI-001 b.i.d.
Eligibility criteria:
Inclusion Criteria:

Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (IP).
Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.
Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).
Subject has been genotyped previously and has their identity confirmed (if required).

Exclusion Criteria:

Subject or parent/LAR is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit (Visit 1) which could interfere with the conduct of study evaluations.
Subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. Mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary.
Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder.
Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
Subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems.
Subject has any clinically significant abnormality on 12-lead ECG performed at the Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Gabapentin plus standard supportive care

Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
Eligibility criteria:
Inclusion Criteria:

Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
Age ≥ 18.
ECOG performance status ≤ 1.
Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.

Exclusion Criteria:

Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
Patients with metastatic disease are excluded from this clinical trial.
Patient with allergies or hypersensitivity to gabapentin.
Patients receiving surgery as part of their definitive management.
Patients who have received prior chemotherapy or radiation therapy.
Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
Intervention: Metoclopramide
Trial phase: Phase 4
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Metoclopramide 10mg IV

+ Bilateral greater occipital nerve block with normal saline

Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
Eligibility criteria:
Inclusion Criteria:

Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.

Exclusion Criteria:

Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Intervention: Welchol
Trial phase: Phase 2
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.

Baseline testing: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, medication pick up.

Treatment period: subject takes study drug 1875 mg orally twice daily with lunch and supper for 4-5 weeks.

Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.

Colesevelam: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.
Eligibility criteria:
Inclusion Criteria:

Females and males age 18 -75.
An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort.
Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid >2000 micromoles/48h

Exclusion Criteria:

IBS patients with known clinically-relevant inflammation.
IBS patient with known bleeding diathesis
History of abdominal surgery

Patients participating will not take any of the following disallowed medications for at least 7 days prior to and during the remainder of the study:

Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron
Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors
All narcotics
Anti-cholinergic agents
Tramadol
Oral anticoagulants
Antimuscarinics
Peppermint oil
Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole

Gastrointestinal preparations:

Anti-nausea agents
Osmotic laxative agents
Prokinetic agents
5-HT3 antagonists
Intervention: ALBUTEROL
Trial phase: Phase 2
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: This is a cross-over study. All participants received albuterol.
Eligibility criteria:
Inclusion Criteria:

A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units and pulmonary arterial wedge pressure <15mmHg, as documented by right heart catheterization within the last 3 years
Regular use of oral pulmonary vasodilators

Exclusion Criteria:

Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)
women of childbearing potential who do not use accepted birth- control measures
pregnant and breast-feeding women
respiratory infection within 4 weeks of testing
A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the experiment day
A resting O2 saturation of < 90%
Current smoking
BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea
Use of inhaled or intravenous pulmonary vasodilators
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.

Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipients with stable graft function.
More than 1 months post-transplant.
18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

Exclusion Criteria:

Multi-organ patients (kidney/pancreas, kidney/liver).
Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
Inability to self-administer the QOL questionnaires.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).

Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Eligibility criteria:
Inclusion Criteria:

Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
Surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

Minimally invasive heart surgery through thoracotomy approach
Patient undergoing procedures under deep hypothermic circulatory arrest
Patients with active infections such as infective endocarditis
Emergency surgery
Patients undergoing transplantations and ventricular assist device insertion
Patients on any mechanical circulatory support preoperatively
Patient's refusal
End stage liver or renal disease
Allergy to bupivacaine
Patient who cannot understand the study procedure or refuse to participate
Redo-sternotomy
Participation in another study
Patients with severe right or left ventricular dysfunction (EF< 25%)
Patients requiring chronic opioids for chronic pain condition
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).

Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Eligibility criteria:
Inclusion Criteria:

Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
Surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

Minimally invasive heart surgery through thoracotomy approach
Patient undergoing procedures under deep hypothermic circulatory arrest
Patients with active infections such as infective endocarditis
Emergency surgery
Patients undergoing transplantations and ventricular assist device insertion
Patients on any mechanical circulatory support preoperatively
Patient's refusal
End stage liver or renal disease
Allergy to bupivacaine
Patient who cannot understand the study procedure or refuse to participate
Redo-sternotomy
Participation in another study
Patients with severe right or left ventricular dysfunction (EF< 25%)
Patients requiring chronic opioids for chronic pain condition
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.

Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
Eligibility criteria:
Inclusion Criteria:

Age 25 to 75 years
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (Primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort

Hepatic insufficiency

o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2

Renal insufficiency (ESRD, HD, estimated creatinine clearance < 50 ml/min)

Severe CRI may impair duloxetine clearance
CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)]
Patients younger than 25 years old and older than 75
Patients intending to receive general anesthesia
Allergy or intolerance to one of the study medications
Patients with an ASA of IV
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Patients with major prior ipsilateral open knee surgery.

Chronic opioid use (taking opioids for longer than 3 months)

However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.
This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.
Intervention: Trimetazidine
Trial phase: Phase 2 | Phase 3
ATC code: C01EB15
SMILES: COc1ccc(CN2CCNCC2)c(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.

Trimetazidine: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
Eligibility criteria:
Inclusion Criteria:

Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
Signed informed consent

Exclusion Criteria:

Patient belonging to post-capillary, Isolated post-capillary, or combined post -capillary and pre-capillary pulmonary hypertension according to 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
Moderate to severe chronic pulmonary obstructive disease
Right Ventricular Ejection Fraction > 45% assessed by cardiac magnetic resonance.
Documented left ventricular dysfunction with left ventricular ejection fraction < 50% assessed by cardiac magnetic resonance.
Severe renal impairment (Serum creatinine > 2.5 mg/dL, eGFR < 30ml/min/1.73 m^2, or routine dialysis treatment).
Malignant arrhythmia such as total atrioventricular block or ventricular fibrillation or unstable ventricular tachycardia.
Patients who are receiving or have been receiving any investigational drugs within 1 month before the baseline visit
Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements
Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
Females who are lactating or pregnant or those who plan to become pregnant during the study
Known Parkinson disease
Known hypersensitivity to any of the drug formulation
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Saline will be administered at the same rate as the ketamine infusion.
Eligibility criteria:
Inclusion Criteria:

Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
If female, subject is non-lactating and is either:
Not of childbearing potential
Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

anxiety
psychiatric disorder
Allergy or sensitivity to ketamine or dilaudid
Deemed un-acceptable by study team
Cognitively impaired (by history)
Subject requires chronic antipsychotic medication
Subject known to be in liver failure
Subject for whom opioids or ketamine are contraindicated
Patients with narrow angle glaucoma
Patients with a history of psychosis
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.

Infusion will be maintained for 24 hours.
Eligibility criteria:
Inclusion Criteria:

Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
If female, subject is non-lactating and is either:
Not of childbearing potential
Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

anxiety
psychiatric disorder
Allergy or sensitivity to ketamine or dilaudid
Deemed un-acceptable by study team
Cognitively impaired (by history)
Subject requires chronic antipsychotic medication
Subject known to be in liver failure
Subject for whom opioids or ketamine are contraindicated
Patients with narrow angle glaucoma
Patients with a history of psychosis
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.

Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Eligibility criteria:
Inclusion Criteria:

Patients having sleeve gastrectomy
Surgeries performed by a particular surgeon - Dr. Sam Wasser
Body Mass Index greater than 35
American Society of Anesthesiologists Score II and III patients

Exclusion Criteria:

Patients having a different type of bariatric surgery including but not limited to duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy
Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.
Pregnancy
Allergic to sugammadex, Zofran or scopolamine
Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled
American Society of Anesthesiologists Score I, IV, V patients