anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 83
Group description: Diclofenac sodium topical solution 1.5%: Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Eligibility criteria:
INCLUSIONARY CRITERIA:

Subject with acute and chronic localized musculoskeletal pain
Ages 18 to 80 years
Subjects of all races, gender or ethnic groups
Female subjects of childbearing age must have a negative pregnancy test Female subjects of childbearing age who are sexually active must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
Willing to provide written informed consent
Patients taking opioid or NSAID for their musculoskeletal pain may be included if pain is inadequately controlled

EXCLUSIONARY CRITERIA:

Patients meeting any of the following criteria will be excluded from the study: Use within 3 days of any topical agents on the affected area
Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses
Subject with history of uncontrolled diabetes (A1C of more than 9)
Subject with history of uncontrolled hypertension (SBP > 160 and DBP > 95)
Subject with active uncontrolled GERD (defined as more than 2 episodes per week) or history of peptic ulcer disease
Subject with active cancer, spinal cord lesions or spine surgery
Subject with allergies to diclofenac or to other non-steroid anti-inflammatory drugs (NSAID)
Known allergies to any oils, methyl salicylate and/or camphor
Subject is pregnant or lactating
Subject with history of heart attack, stroke or blood clot, or recent coronary artery bypass graft surgery (CABG) (i.e., within the last six months)
Subject with history of alcohol or drug abuse within 1 year
Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the subject's ability to participate in the study as determined by the Investigator
Intervention: Bupropion Hydrochloride
Trial phase: Phase 2
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Bupropion SR: Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks
Eligibility criteria:
Key Inclusion Criteria:

Age 18 years or above
Daily smoker using 10 or more cigarettes per day
Willing to be smoke-free for 7 days
Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.
Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.

Key Exclusion Criteria:

Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)
Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
Not pregnant or breastfeeding
Contraindication to the use of bupropion.
Additional criteria may apply.
Intervention: Empagliflozin
Trial phase: Phase 4
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 10mg once a day for 6 months
Eligibility criteria:
Inclusion Criteria:

Patients should meet the following inclusion criteria:
Ambulatory patients age 18-85 years
Diagnosis of Heart failure (NYHA II to III)
LVEF<50% on echocardiography or CMRI in the previous 6 months
Have stable symptoms and therapy for HF within the last 3 months.

Exclusion Criteria:

Pregnant or lactating women.
Any history of diabetes by medical history or by any of the established criteria by the American Diabetes Association. It also includes patients with history of diabetes in remission.
ACS or cardiac surgery within the last 3 months.
Cancer or any other life-threatening condition.
Pancreatitis.
Glomerular Filtration Rate < 45 ml/Kg/min.
Use of continuous parental inotropic agents.
Systolic BP < 90 mm Hg.
Psychiatric disease incompatible with being in study.
Any contraindication to MRI procedures.
Any other medical or physical condition considered to be inappropriate by a study physician.
Intervention: Zaleplon
Trial phase: Phase 2
ATC code: N05CF03
SMILES: CCN(C(C)=O)c1cccc(-c2ccnc3c(C#N)cnn23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV
Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.
Subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study
Current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week))
Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study)
Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury
Clinically significant history of liver disease
Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis
Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness
History of substance abuse or dependence over the past 6 months
Currently taking medication to assist with sleep (e.g., Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam, Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon, Sonata/Zaleplon, Melatonin, Unisom, Benadryl).
Pregnant
Intervention: Gemfibrozil
Trial phase: Phase 2
ATC code: C10AB04
SMILES: Cc1ccc(C)c(OCCCC(C)(C)C(=O)O)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Gemfibrozil 600 mg by mouth twice daily

Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day
Eligibility criteria:
Inclusion Criteria:

males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
interested in cutting down or quitting drinking
able to provide voluntary informed consent
have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days

Exclusion Criteria:

severe liver disease; severe kidney disease; gallbladder disease or gallstones
chronic renal or hepatic failure
recent pancreatitis
insulin-dependent diabetes
other urgent medical problems
moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)
schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)
active legal problems with the potential to result in incarceration
pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)
current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics
regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68
a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years
a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30 minutes69)
left-handedness
any contraindications for MRI
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: 200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)

Thiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
Eligibility criteria:
Inclusion Criteria:

Adult ≥18 years of age
Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
Serum lactate ≥2mmol/L
Creatinine >1.0mg/dL

Exclusion Criteria:

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Renal replacement therapy within the past 30 days
Comfort measures only or anticipated withdrawal of support within 24 hours
Protected populations (pregnant women, prisoners)
Known thiamine allergy
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 896
Group description: Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).

Exclusion Criteria:

Four or more episodes of a mood disturbance within the 12 months before Visit 1;
Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
Eligibility criteria:
Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).

Exclusion Criteria:

Four or more episodes of a mood disturbance within the 12 months before Visit 1;
Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 587
Group description: Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
Intervention: ALDUMASTAT
Trial phase: Phase 2
SMILES: C[C@H]1CN(C(=O)CC[C@@]2(C3CC3)NC(=O)NC2=O)CCN1c1cc(F)cc(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 232
Group description: Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Male participants or female participants of non-childbearing potential and not breastfeeding.
Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.
Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.
Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion Criteria:

Severe clinical knee malalignment according to the investigator.
Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).
Knee prosthesis already foreseen within the study period (whichever side).
Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).
Previous osteotomy on the inferior limbs (whichever side).
Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
Other pathologies affecting the target knee.
Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
Intervention: Sildenafil
Trial phase: Phase 2
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.

Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)
Eligibility criteria:
Inclusion Criteria:

For Athletes

Age 18-35
Male or female professional boxers/MMA fighters
Ability to undergo MR imaging procedures

At least one of the following:

Knockout (KO)/Technical Knockout (TKO) scored by fight referee.
Greater than 25 blows to the head.
Significant post-concussive symptoms (Symptom Score > 1 on at least 3 items from the Rivermead Post-Concussion Questionnaire)

For Controls

Age 18-35
Male of female who do not participate in contact sports
Screen negative for mild TBI (mTBI) using Ohio State TBI Identification

Exclusion Criteria:

Contraindication to sildenafil which includes the following:

Current use of organic nitrate vasodilators
Use of ritonavir (HIV-protease inhibitor)
Current use of erythromycin, ketoconazole, or itraconazole
Current use of cimetidine
Current resting hypotension (BP < 90/50 mm Hg)
Current severe renal insufficiency (Creatinine Clearance < 30 milliliters/minute)
Current hepatic cirrhosis
Current cardiac failure or coronary artery disease causing unstable angina
Retinitis pigmentosa
Known hypersensitivity or allergy to sildenafil of any of its components
Daily therapy with a PDE5 inhibitor within the past 2 months
Immediate hospitalization for severe concussion
History of neurological or psychiatric disorder not related to TBI
Known inclusion in another interventional clinical trial
Subjects with metal implants that would interfere with the MR imaging procedures
Sickle cell disease
History of priapism
Intervention: Ursodeoxycholic acid
Trial phase: Phase 2
ATC code: A05AA02
SMILES: [H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Ursodeoxycholic Acid: weight-based dosing
Eligibility criteria:
Inclusion Criteria:

Systemic sarcoidosis with evidence of liver involvement as denoted by any of the following:

Elevated liver-specific alkaline phosphatase
Granulomas on liver biopsy
Hepatomegaly on imaging
Portal Hypertension (via imaging or endoscopy)
Stable dose of immunosuppressant, if taking (no dose variation for 6 months)
If cirrhotic, absence of hepatocellular carcinoma as indicated by imaging within 6 months of screening

Exclusion Criteria:

Female who is pregnant, planning to become pregnant during the study, or breastfeeding
Clinically significant abnormalities, co-morbidities, or recent alcohol/drug abuse that make the subject an unsuitable candidate
Concurrent liver disease including hepatitis B, hepatitis C, alcohol-related liver disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
Currently on UDCA
Prior intolerance to UDCA
Receipt of any investigational product within a time period equal to 10 half-lives of the product, or 6 weeks (whichever is longer), to study drug administration
Current evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites). In the event potential participant is post-transplant, no evidence of hepatic decompensation since transplantation