anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Zoledronic acid
Trial phase: Phase 3
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Single infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.

Zoledronic acid: 5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Eligibility criteria:
Inclusion Criteria:

Ages 18-65, male or female
Traumatic SCI with Neurological level C4-T10, American Spinal Injury Association (ASIA) Impairment Scale (AIS) A,
Serum calcium level >7.0 mg/dL) at time of study drug administration
Screening baseline serum 25-hydroxy (25-OH) vitamin D of at least 13 ng/ml
No medical contraindication to supplemental vitamin D for participants whose levels are >13 ng/ml but sub-therapeutic (<32ng/ml)
No medical contraindication to supplemental calcium
Weight under 300 pounds, which is the maximum permitted on the dual-energy X-ray absorptiometry (DXA) scanner

Exclusion Criteria:

Ventilator-dependent individuals
Chronic steroid use (defined as >6 months)
Rheumatoid disease with use of prior disease modifying anti-rheumatic drugs (DMARDs) affecting bone density
History of osteoporosis or of treatment for osteopenia or osteoporosis with bisphosphonates, or selective reuptake estrogen modifying agents
Current use of medications* including bisphosphonates to treat osteoporosis (*note that prior calcium or vitamin D use is not an exclusion criteria)
History of more than one lower extremity osteoporosis-related fracture
Chronic renal insufficiency, creatinine clearance < 35 ml/min, during screening
End stage liver or kidney disease
Medical conditions resulting in hypogonadal states that affect bone density
Uncontrolled thyroid disease/thyrotoxicosis
Hereditary or acquired metabolic bone disorder
History of use of unfractionated heparin for >1 year
History of selected antiseizure medications, specifically phenobarbital, phenytoin, carbamazepine, sodium valproate >1 year
Acute or chronic bilateral lower extremity fractures involving tibia or femur, with placement of surgical hardware in any areas of above locations
Severe hypotension requiring use of intravenous blood pressure agents such as dopamine, norepinephrine or phenylephrine. Exception may allow for patients on pressors who arm experiencing hypotension as they acclimate to upright posture.
Inability to provide informed consent and understand the consent process
Facial fractures requiring oral surgery
Dental surgery or oral maxillofacial surgery within 2 weeks of anticipated study drug administration
Pregnancy present on admission
Vitamin D deficiency on admission testing (serum 25-OH D reported as < 13 ng/mL)
Patients with an established reaction to, or history of, anaphylactic shock to aspirin
Intervention: Terpinen-4-ol
Trial phase: Phase 1
SMILES: CC1=CCC(O)(C(C)C)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.

Terpinen-4-ol: Lid scrub once or twice per day for one month.
Eligibility criteria:
Inclusion Criteria:

Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
Age range: 15-80 years old.
Both genders and all ethnic groups comparable with the local community.
Able to understand and willing to sign a written informed consent
Able and willing to cooperate with the investigational plan.
Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
Children under 15.
Pregnant women or expecting to be pregnant during the study.
Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
Concomitant use of systemic antibiotics or steroids.
Contact lens wear (unless discontinued for ≥ 30 days before randomization)
Active ocular infection or allergy
Unable to close eyes or uncontrolled blinking
Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
Previous allergic reaction to TTO-containing products or cosmetic fragrance.
Intervention: Lidocaine and tetracaine
Trial phase: Phase 1 | Phase 2
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1.CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: 70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
Eligibility criteria:
Inclusion Criteria:

Men and women, age 40 years and above
Meet American College of Rheumatology criteria for knee OA
Knee pain most days of the week for the past month
Knee pain > 5/10 after exercise intervention
Capable of undertaking exercise intervention
Stable cardiovascular function
Able to return for all clinic visits
Able to read and understand the informed consent document

Exclusion Criteria:

Use of a walker to ambulate or inability to ambulate
Other forms of arthritis
Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
History of myocardial infarction
Blood Pressure > 140 systolic/100 diastolic
Scheduled for and likely to need joint replacement surgery in the next 3 months
Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
Intervention: Memantine Hydrochloride
Trial phase: Phase 4
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Participants who received Memantine 10 mg capsule twice per day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patient assessment by Dr. Khan (co-I).
Receiving prednisone therapy of at least 5 mg of prednisone/day for at least 6 months with anticipated treatment for ≥ 12 additional months.
Age 18-65 years.
Baseline CVLT-II total T score ≤ 54.

Exclusion Criteria:

Illnesses associated with CNS involvement (e.g., seizures, brain tumors, head injury with loss of consciousness) or cognitive impairment (e.g., substance dependence within the past 2 years, bipolar disorder) Potential participants with mood symptoms secondary to corticosteroids (based on SCID) will not be excluded because this could selectively exclude subjects who are sensitive to the CNS effects of corticosteroids.
Vulnerable populations (e.g. severe cognitive impairment, pregnant or nursing women, prisoners).
Severe or life-threatening medical illness that would make completion of study unlikely
Contraindications to memantine therapy (e.g. severe side effects in the past)
Danger to self or others as defined by > 1 lifetime suicide attempt or assault, any suicide attempt or assault within the past year, and active suicidal or homicidal ideation with plan and intent.
Metal implants, claustrophobia, or other contraindications to MRI
Intervention: Travoprost
Trial phase: Phase 1
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 25
Group description: Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
Eligibility criteria:
Inclusion Criteria:

Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
Intraocular surgery within the past 30 days prior to the Screening Visit.
Any abnormality preventing reliable tonometry.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
Body weight < 5kg.
Other protocol-defined exclusion criteria may apply.
Intervention: Levetiracetam
Trial phase: Phase 1 | Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children.
Eligibility criteria:
Inclusion Criteria:

Comatose with Blantyre Comas Score ≤ 3
P. falciparum parasitemia
Active seizure

Exclusion Criteria:

Serum creatinine > 2mg/dL
Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: One drop to the study eye(s) once a day in the evening for 6 months
Eligibility criteria:
Inclusion Criteria:

Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Able to follow instructions and be willing and able to attend all study visits.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
Must read, sign, and date an Ethics Committee-approved informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
Contact lens wear.
Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
Unwilling to risk the possibility of darkened iris or eyelash changes.
Participation in any other investigational study within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.
Intervention: Paclitaxel
Trial phase: Not Applicable
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Eligibility criteria:
Inclusion Criteria:

Mucinous cysts (premalignant or malignant cysts of the pancreas)
Normal organ and marrow function
Baseline CT within 6 months of enrollment

Exclusion Criteria:

Pregnant or breastfeeding
Acute active pancreatitis
Complicated pancreatic cysts
Subjects who do not speak English
Intervention: Palbociclib
Trial phase: Phase 1
ATC code: L01EF01
SMILES: CC(=O)c1c(C)c2cnc(Nc3ccc(N4CCNCC4)cn3)nc2n(C2CCCC2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: PD 0332991 will be given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Eligibility criteria:
Inclusion Criteria:

Adults age ≥ 18 years

Multilineage bone marrow failure
Serum creatinine ≤ 2.0 mg/dl
Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)
Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic infiltration
Left ventricular ejection fraction ≥ 45%
QTc ≤ 470 msec
RB expression is required for the action of PD 0332991. Because rb deletions and mutations are rare in acute leukemias and MDS, screening for RB expression will not be required before enrollment. Pretreatment biopsies will be stored and analyzed for RB expression if needed subsequently.

Exclusion Criteria:

• No more than 5 cytotoxic regimens

Previous allogeneic or autologous stem cell transplantation permitted
≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy
≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine
If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning PD 0332991
No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning PD 0332991
Intervention: Diclofenac sodium
Trial phase: Phase 2
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Eligibility criteria:
Inclusion Criteria:

Out-patients of either gender.
Patients aged ≥ 18 to ≤ 65 years old.
Subjects able and willing to give their written consent prior to inclusion in the study.
Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion Criteria:

General

Patients refusing to give written informed consent.
Patients not able to understand the purposes of the study or not willing to return for the control visits.
Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
Patients enrolled in any clinical trial in the previous 3 months.
Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
Pregnant or breast-feeding women.
Alcohol or drug abuse in the previous 12 months.
Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Intervention: Travoprost
Trial phase: Not Applicable
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Treated with Travoprost (0.04%)

travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
Eligibility criteria:
Inclusion Criteria:

good systemic health
irido-corneal angle open
intraocular pressure more than 18 mmHg

Exclusion Criteria:

having cardiovascular problem
Hypertension or diabetes
under systemic medication for high blood pressure
had an ocular surgery in the past
Intervention: Decitabine
Trial phase: Phase 2
ATC code: L01BC08
SMILES: Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.

Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
Eligibility criteria:
Inclusion Criteria:

Sign an Institutional Review Board (IRB)-approved informed consent document.
Age >/= than18 years
de novo or secondary International Prostate Symptom Score (IPSS) low- or intermediate-1 - risk MDS, including CMML
Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

Breast feeding females
Prior therapy with decitabine or azacitidine
Intervention: Glycine
Trial phase: Phase 2
ATC code: B05CX03
SMILES: NCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks

glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
Eligibility criteria:
Inclusion Criteria:

Triplication of glycine decarboxylase gene

Exclusion Criteria:

Normal glycine decarboxylase copy number
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.

Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

Exclusion Criteria:

Hypersensitivity to dexmedetomidine
Bradycardia: Sinus rhythm slower than 50 bpm
Known or suspected obstructive sleep apnea
Suspected difficult intubation
Pregnancy
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form
Intervention: Sildenafil
Trial phase: Phase 3
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
Eligibility criteria:
Inclusion Criteria:

>18 years
Written inform consent
PH secondary to diastolic left heart failure defined as
PAP mean >25 mmHg
Wedge mean >15 mmHg
Normal systolic left ventricular (LV) function on echo/nuclear imaging (left ventricular ejection fraction (LVEF) > or =45%)
New York Heart Association class (NYHA) II-IV despite heart failure therapy

Exclusion Criteria:

Severe noncardiac limitation to exercise (as severe chronic obstructive pulmonary disease)
Other cause of PH besides diastolic heart failure
Coronary ischemia or recent myocardial infarction (<6 months)
Hypotension ( <90/50 mmHg)
Ongoing nitrate therapy
Ongoing therapy with citochrome P450 3A4 ( CYP3A4) inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or CYP3A4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, Sint Janskruid ). Furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of Sildenafil.
Ongoing therapy with alpha -inhibitors
Significant mitral or aortic valve dysfunction
Severe liver dysfunction
Pregnancy
Unable to read and comprehend Dutch language