anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks and

tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
Eligibility criteria:
Inclusion Criteria:

Biological female aged 40-60
Documented HIV-1 infection
Peri-menopausal ( as documented by history).
Signed Informed Consent Form and willing to comply with the protocol.
Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks.
Stable viral suppression (plasma HIV-RNA<50 copies/mL for > 24 weeks). Single viral blip <500/ml allowed if re-suppresses.
If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.

Exclusion Criteria:

HIV-2
High 10-year fracture risk at baseline ( > 20%) based on country specific FRAX
Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
Acute viral hepatitis
Chronic hepatitis C with liver transaminases >5 x ULN or expected to require treatment for hepatitis C during the trial period.
Any investigational ARV within 30 days.
Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ 3 x ULN and bilirubin ≥ 1.5 x ULN with > 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices.
Pregnant or breastfeeding
Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, creatinine phosphokinase, or lipid elevation.
Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks.

tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
Eligibility criteria:
Inclusion Criteria:

Biological female aged 40-60
Documented HIV-1 infection
Peri-menopausal ( as documented by history).
Signed Informed Consent Form and willing to comply with the protocol.
Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks.
Stable viral suppression (plasma HIV-RNA<50 copies/mL for > 24 weeks). Single viral blip <500/ml allowed if re-suppresses.
If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.

Exclusion Criteria:

HIV-2
High 10-year fracture risk at baseline ( > 20%) based on country specific FRAX
Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
Acute viral hepatitis
Chronic hepatitis C with liver transaminases >5 x ULN or expected to require treatment for hepatitis C during the trial period.
Any investigational ARV within 30 days.
Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ 3 x ULN and bilirubin ≥ 1.5 x ULN with > 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices.
Pregnant or breastfeeding
Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, creatinine phosphokinase, or lipid elevation.
Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Intervention: Oliceridine
Trial phase: Phase 3
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 76
Group description: Oliceridine 0.1 mg
Eligibility criteria:
Inclusion Criteria:

Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.
Intervention: Oliceridine
Trial phase: Phase 3
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 79
Group description: Oliceridine 0.35 mg
Eligibility criteria:
Inclusion Criteria:

Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.

Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.

Nicotine: Open-label transdermal nicotine patch
Eligibility criteria:
Inclusion Criteria:

Age > 60 years;
DSM-5 (Diagnostic and statistical manual-5) diagnosis of major depressive disorder, single or recurrent episode;
Subjective cognitive decline, defined as endorsing 20% of items on the Cognitive Complaint Index (CCI);
depression severity: MADRS (Montgomery-Asberg Depression Rating Scale) ≥ 15;
cognition: MOCA (Montreal Cognitive Assessment) ≥ 24;
fluent in English;
intact hearing / vision allowing completion of study procedures;
for individuals on antidepressants at study entry, they must be on a stable dose for at least 6 weeks.

Exclusion Criteria:

Other Axis I psychiatric disorders, except for anxiety symptoms occurring in a depressive episode;
History of alcohol or drug dependence or abuse in the last 3 years;
Tobacco or nicotine use in last year;
History of a developmental disorder or IQ score < 70;
Acute suicidality;
Acute grief (<1 month);
Current or past psychosis;
Primary neurological disorder, including dementia, stroke, brain tumors, etc.;
Any MRI contraindication;
Unstable medical illness;
Allergy or hypersensitivity to nicotine patches;
Regular use of drugs with centrally acting cholinergic or anticholinergic properties in last 4 weeks, including acetylcholinesterase inhibitors;
Current or planned psychotherapy;
Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last two months.
Intervention: rhEPO
Trial phase: Phase 4
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Patients who are enrolled and randomized to the Epoetin arm will remain on their pre-enrollment dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.

Epoetin Alfa: The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.

All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.

It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal.
Eligibility criteria:
Inclusion Criteria:

age ≥19 years
receiving in-center hemodialysis two or more times weekly
anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)<100g/L in the absence of other causes of anemia
if female, must be using an approved method of contraception or judged unable to become pregnant
able to give informed consent

Exclusion Criteria:

acute kidney injury likely to resolve
plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
expected lifespan of less than six months due to a medical condition other than chronic kidney disease
current hematologic condition that may cause anemia
use of medications known to cause anemia
use of any investigational drug or androgen within 90 days of screening
significant bleeding within 30 days of screening
red blood cell transfusion(s) within 30 days of screening
documented or suspected pure red cell aplasia (PRCA)
current iron deficiency
documented allergy or intolerance to intravenous sodium ferric gluconate
known or probable ESA resistance
uncontrolled hypertension
an intention to relocate to a different dialysis center in the near future
Intervention: Lumateperone
Trial phase: Phase 3
ATC code: N05AD10
SMILES: CN1CCN2c3c(cccc31)C1CN(CCCC(=O)c3ccc(F)cc3)CCC12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of probable Alzheimer's disease
Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
Able to attend outpatient clinic visits with primary caregiver

Exclusion Criteria:

Unable to comply with study procedures
Considered medically inappropriate for study participation
Intervention: Naltrexone
Trial phase: Not Applicable
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: single 50mg dose of naltrexone

Naltrexone
Eligibility criteria:
Inclusion Criteria:

good health
between the ages of 18 and 35,
fluent in English
right-handed (for the fMRI scan)

Exclusion Criteria:

Self-reported current or past diagnoses of physical or mental illness.
Score on the Patient Health Questionnaire (depressive symptoms) above a 13
Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
Positive urine pregnancy test
Use of any prescription medication, except for birth control
Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
Self-reported problems with liver functioning, including hepatitis or liver failure
Difficulty swallowing or taking pills
BMI greater than 35 or weight greater than 400 lbs
Claustrophobia
Nonremovable metal in the body
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).

Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day.

cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.

A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties.
Eligibility criteria:
Stage 1:

Inclusion criteria:

Male or female subjects between 45 and 78 years of age inclusive.
Willing and able to give informed consent.
Idiopathic PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
Rest tremor amplitude score of ≥2 in any limb on question 3.17 of the MDS-UPDRS (ON state).
Anti-parkinsonian medication is fixed for at least 1 month prior to study entry
If MoCA<22 subject must have a legally authorized representative (LAR) sign the consent, and must have a designated caregiver that agrees to ensure study protocols followed. This includes accompanying patient to study visits and being available for study phone calls.
Must have a driver to drive them to and from study visits
Has a significant other (someone who knows the subject well) that is appropriate for doing the NPI assessment, can accompany patient to study visits, and agrees to do so
Agrees to not take more than 1 gram per day of acetaminophen, due to a possible interaction with study drug that could increase risk of hepatotoxicity.

Exclusion criteria:

Known or suspected allergy to cannabinoids or excipients used in the study drug formulation.
Cannabinoids taken currently or in the previous 30 days.
History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient stats s/he has a history of this.
Use of dopamine blockers within 180 days and amphetamine, cocaine, and MAO-A inhibitors within 90 days of baseline.
Currently taking tolcapone, valproic acid, felbamate, niacin, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole because of risk of toxic interactions with the study drug. These medications need to be stopped 90 days before the baseline visit.
Unstable medical condition.
Any of the following laboratory test results at screening:
Intervention: Upadacitinib
Trial phase: Phase 2 | Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.

Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.

If female, participant must meet the criteria for Contraception Recommendations
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
Current diagnosis of fulminant colitis and/or toxic megacolon
Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria
Intervention: Upadacitinib
Trial phase: Phase 2 | Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.

Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.

If female, participant must meet the criteria for Contraception Recommendations
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
Current diagnosis of fulminant colitis and/or toxic megacolon
Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria
Intervention: Oliceridine
Trial phase: Phase 3
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 77
Group description: Oliceridine 0.1 mg
Eligibility criteria:
Inclusion Criteria:

Has undergone abdominoplasty with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.