anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tetrabenazine
Trial phase: Phase 2 | Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.

Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
Eligibility criteria:
Inclusion Criteria:

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female subjects must not be pregnant and agree to an acceptable method of contraception

Exclusion Criteria:

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial and received study drug within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months
Intervention: ALENDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Drug: Weekly oral alendronate 70 mg for 12 months

Supplements: Calcium and Vitamin D daily for 12 months

Alendronate: Weekly oral alendronate 70 mg for 12 months

Calcium: Daily Oral 1000 mg

Vitamin D: Daily Oral 1000 IU
Eligibility criteria:
Inclusion Criteria:

Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).
Individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication.
Individuals with poor dental hygiene.
Individuals with esophageal abnormalities.
Individuals who are not able to tolerate alendronate treatment.
Individuals who will not be able to return for all study visits.
Patients may not be receiving any other investigational agents.
Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
Intervention: Fruquintinib
Trial phase: Phase 2
ATC code: L01EK04
SMILES: CNC(=O)c1c(C)oc2cc(Oc3ncnc4cc(OC)c(OC)cc34)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Eligibility criteria:
Inclusion Criteria:

≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
Histological or cytological confirmed metastatic colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Failed 2 or more lines of chemotherapy
Adequate hepatic, renal, heart, and hematologic functions
At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Signed and dated informed consent.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

Pregnant or lactating women
Any factors that influence the usage of oral administration
Central nervous system (CNS) metastasis
One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
Abuse of alcohol or drugs
Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
Disability of serious uncontrolled intercurrence infection
Proteinuria ≥ 2+ (1.0g/24hr)
Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
Bone fracture or wounds that was not cured for a long time
Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.

Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
Eligibility criteria:
Inclusion Criteria:

Hip fracture or elective hip or knee arthroplasty
Age 65 years or older
Life expectancy > 3 months

Exclusion Criteria:

Pathological hip fracture due to cancer
Currently taking a statin, or took a statin within the last 30 days
Previous statin intolerance
Acute myocardial infarction or unstable angina
History of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization
Hip fracture patients with peripheral arterial disease
Hip fracture patients with history of stroke or transient ischemic attack.
Muscle disorder
Serious liver disease or alanine aminotransferase > 3x upper limit of normal
Serious renal disease (creatinine clearance <30cc/min)
Treatment with HIV protease inhibitor or Hepatitis C protease inhibitor
Treatment with erythromycin, clarithromycin, niacin or azole antifungal agent
Pregnant, planning to become pregnant, or breastfeeding
Intervention: Citicoline
Trial phase: Phase 2
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All participants received citocoline.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of FXTAS

Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits

Exclusion Criteria:

Legal incapacity or limited legal capacity
Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance <60 mL/min) or hepatic disease.
Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
Allergy/sensitivity to the drug of its formulations.
Concurrent participation in another clinical study.
Active substance use or dependence.
Serious illness (requiring systematic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: THA:

33 patients received a spinal anesthetic using Fentanyl and Bupivacaine

Injection into capsular tissue after placement of the acetabular component:

0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline

TKA:

39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc

Injection into posterior capsule of the knee:

0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline

TSA:

35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.

Standard of care analgesia
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of osteoarthritis
Elected to undergo primary TKA, THA, or TSA

Exclusion Criteria:

Age < 18 years
Pregnant or breastfeeding
Non-English speaking
Unable to give informed consent
Previous open hip, knee or shoulder surgery
Pre-determined patients discharging to ECF
Patients with allergies to bupivacaine
Patients currently taking opioid pain medication
Patients with contraindication to nerve blocks
Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
Patients with severe hepatic disease
Patients with chronic heart disease as defined as a decreased ejection fraction
Intervention: Tetrabenazine
Trial phase: Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.
Eligibility criteria:
Inclusion Criteria:

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
Participants with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female participants must not be pregnant and agree to an acceptable method of contraception

Exclusion Criteria:

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months
Intervention: Desflurane
Trial phase: Not Applicable
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Transcranial motor evoked potentials are obtained under TIVA and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control

Desflurane
Eligibility criteria:
Inclusion Criteria:

Age 12 through 17 years
Diagnosis of idiopathic scoliosis
Scheduled for posterior spinal fusion with neurophysiological monitoring
No known allergies to propofol or remifentanil
No contraindication to total intravenous anesthesia
No contraindications to the administration of volatile agents

Exclusion Criteria:

Failure to consent or assent to study
Diagnosis other than idiopathic scoliosis
Poorly controlled seizures or the presence of a cochlear implant
Patient history or family history of malignant hypothermia or mitochondrial myopathies
Intervention: Bupivacaine
Trial phase: Phase 4
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: 12
Group description: Single administration of EXPAREL 133 mg (10 mL).

EXPAREL
Eligibility criteria:
Inclusion Criteria:

Male or female, ≥18 years of age at the Screening Visit.
Subjects undergoing tonsillectomy with or without removal of the adenoids.
Able and willing to comply with all study visits and procedures.
Willing and capable of providing written informed consent.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study.
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration.
Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.
Intervention: Prazosin
Trial phase: Phase 4
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: prazosin pill

Prazosin
Eligibility criteria:
Inclusion Criteria:

PTSD
Frequent nightmares
Suicidality

Exclusion Criteria:

Schizophrenia
Bipolar
Substance abuse
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: 4
Group description: used in the eye 4 times a day

Cyclosporin 0.05% emulsion: Topical therapy for dry eye
Eligibility criteria:
Inclusion Criteria:

Signature on the written informed consent form
Patient willingness and ability to return for all visits during the study
Rapid tear film break up time of seven seconds or less in at least one eye AND
Both cornea fluorescein staining score greater than or equal to 3 and conjunctival lissamine green staining greater than or equal to 3 in at least one eye
Ocular Surface Disease Index Symptom Severity score of twenty or greater
Tear meniscus height less than or equal to 230um
Intact corneal sensitivity
Willingness to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to enrollment, and during the course of the study

Exclusion Criteria:

Compromised cognitive ability which may be expected to interfere with study compliance
Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
Known hypersensitivity to any components of the artificial tears or cyclosporin A eye drops Anticipated contact lens wear during the study
History of corneal transplant
Active ocular infection, uveitis or non-KCS related inflammation
History of cataract surgery within 3 months prior to enrollment
History of pterygium removal within 6 months prior to enrollment
Reduced corneal sensitivity
Initiation, discontinuation or change in dosage of hormone replacement therapy (HRT), fish oil, evening primrose, flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents, beta-blocking agents, tricyclic or SSRI antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study
Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears)
Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within three months prior to study, or anticipated use of same during study
Intervention: Metronidazole
Trial phase: Phase 4
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Eligibility criteria:
Inclusion Criteria:

Inpatients >55
Proton Pump inhibitor / Histamine-2 Blocker
On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
Anticipated hospital stay >48 hours
Mental capacity (able to give informed written consent).

Exclusion Criteria:

Admission for CDI
Existing diarrhea at admission
Passed prophylactic window (>48 hours on broad spectrum antibiotics)
Unable to take PO at the time of evaluation for study entry
No more than 14 days of broad spectrum antibiotics anticipated
Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
Inflammatory Bowel Disease
Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
Hospice
Mortality expected <7days
Previous CDI in the past 6 months
Intensive care admission due to the difficulty of monitoring them
Allergy to Metronidazole or other Antibiotics in protocol
Patients with neuropathy
History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.
Intervention: Soticlestat
Trial phase: Phase 1
SMILES: O=C(c1cccnc1-c1ccncc1)N1CCC(O)(Cc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-935 15 mg solution, orally, once, on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Exclusion Criteria:

Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-935.
There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Intervention: Soticlestat
Trial phase: Phase 1
SMILES: O=C(c1cccnc1-c1ccncc1)N1CCC(O)(Cc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-935 50 mg solution, orally, once, on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Exclusion Criteria:

Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-935.
There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Intervention: Soticlestat
Trial phase: Phase 1
SMILES: O=C(c1cccnc1-c1ccncc1)N1CCC(O)(Cc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-935 1350 mg solution, orally, once, on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Exclusion Criteria:

Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-935.
There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.