anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Idalopirdine
Trial phase: Phase 3
SMILES: Fc1ccc2c(CCNCc3cccc(OCC(F)(F)C(F)F)c3)c[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 313
Group description: Idalopirdine adjunct to 10 mg Donezepil
Eligibility criteria:
Inclusion Criteria:

The patient has a knowledgeable and reliable caregiver.
The patient is an outpatient.
The patient has probable AD.
The patient has mild to moderate AD.
Stable treatment with donepezil.
The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
The patient has evidence of clinically significant disease.
The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.
Intervention: Idalopirdine
Trial phase: Phase 3
SMILES: Fc1ccc2c(CCNCc3cccc(OCC(F)(F)C(F)F)c3)c[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 309
Group description: Idalopirdine adjunct to 10 mg Donezepil
Eligibility criteria:
Inclusion Criteria:

The patient has a knowledgeable and reliable caregiver.
The patient is an outpatient.
The patient has probable AD.
The patient has mild to moderate AD.
Stable treatment with donepezil.
The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
The patient has evidence of clinically significant disease.
The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.
Intervention: Budesonide
Trial phase: Phase 1 | Phase 2
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Buparid 1mg budesonide/2 ml nebulizer solution

Budesonide: Inhalation Solution
Eligibility criteria:
Inclusion Criteria:

Patient with confirmed diagnosis of chronic rhinosinusitis
Patient without alternative other than sinus surgery
Patient's written informed consent obtained prior to any screening or study-specific procedure
Male or female, ≥ 18 years of age
Patient is able to undergo nasal therapy without restrictions
Capable to correctly use the PARI SINUS device
Capable of understanding the purpose and risk of the clinical trial
Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
Patient is able to participate in the study according to Investigator's opinion

Exclusion Criteria:

Patients with cystic fibrosis
Patients with polyposis nasi grade I-IV
Patients with prior FESS (Functional Endoscopic Sinus Surgery)
Pregnant or breastfeeding women
Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration
No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the clinical trial
Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
Drug or alcohol abuse
End-stage malignancies
Known hypersensitivity to Budesonide
Patients with oral steroid therapy within the last 3 months
Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma
Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics
Patients with frequent epistaxis (> 1 episode per week)
Intervention: Budesonide
Trial phase: Phase 1 | Phase 2
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Budes Nasal Spray 50 µg budesonide/pump

Budesonide: Nasal Spray
Eligibility criteria:
Inclusion Criteria:

Patient with confirmed diagnosis of chronic rhinosinusitis
Patient without alternative other than sinus surgery
Patient's written informed consent obtained prior to any screening or study-specific procedure
Male or female, ≥ 18 years of age
Patient is able to undergo nasal therapy without restrictions
Capable to correctly use the PARI SINUS device
Capable of understanding the purpose and risk of the clinical trial
Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
Patient is able to participate in the study according to Investigator's opinion

Exclusion Criteria:

Patients with cystic fibrosis
Patients with polyposis nasi grade I-IV
Patients with prior FESS (Functional Endoscopic Sinus Surgery)
Pregnant or breastfeeding women
Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration
No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the clinical trial
Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
Drug or alcohol abuse
End-stage malignancies
Known hypersensitivity to Budesonide
Patients with oral steroid therapy within the last 3 months
Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma
Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics
Patients with frequent epistaxis (> 1 episode per week)
Intervention: Indomethacin
Trial phase: Phase 4
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Indomethacin patch to be applied on the sprained ankle twice a day (BID).
Eligibility criteria:
Inclusion Criteria:

Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)

Exclusion Criteria:

Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.
Pregnancy , Breast Feeding and Substance Abuse
Intervention: Cenestin
Trial phase: Phase 4
SMILES: CC12CCC3C(=CCc4cc(OS(=O)(=O)[O-])ccc43)C1CCC2=O.[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly
Eligibility criteria:
Inclusion Criteria:

Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal symptoms for >1 year OR age >55
Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6 months)- one UTI must be documented by culture, others may be documented by urinalysis
Ability to provide informed consent

Exclusion Criteria:

Use of any investigational drug or device within thirty days of screening
Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
Diagnosis of Interstitial Cystitis/painful bladder syndrome
History of urinary tract infections which require the use of IV antibiotics or where only one oral antibiotic is available for treatment, or where the risk of treatment with vaginal estrogen only is deemed unacceptable by the principle investigator secondary to the severity of prior urinary tract infections
Known etiology of infection such as, but not limited to: kidney or bladder stones, enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization, indwelling catheter, poorly controlled diabetes
Urothelial cancer
Actively treated estrogen sensitive tumor (breast or endometrial cancer)
Undiagnosed vaginal bleeding
Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Prolapse requiring pessary use

Deferral Criteria

Undiagnosed hematuria - may enroll after malignancy is ruled out
Use of a progestin containing intrauterine device or use of any vaginal androgens, estrogens or progestins within 3 months of enrollment - may enroll after wash out
Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after wash out if still meets inclusion criteria.
History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Eligibility criteria:
Patients will be recruited among those who complete treatment with aripiprazole in Study 14724A / NCT01795547.

Inclusion Criteria:

The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Intervention: Progesterone
Trial phase: Phase 4
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.

On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.

Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
Eligibility criteria:
Inclusion Criteria:

Sexually active 18-40 year old heterosexual couple
Subject willing to take Mircette birth control pills for at least one cycle (one pack)
Willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse)
IRB signed informed consent

Exclusion Criteria:

Undiagnosed vaginal bleeding
Contraindication to oral contraceptives
Liver dysfunction or disease
Known sensitivity to Crinone
Known or suspected malignancy of the breast or genital organs
History of or active thrombophlebitis or thromboembolic disorders
Use of condoms during intercourse
Male erectile or ejaculatory dysfunction
Intervention: Amenamevir
Trial phase: Phase 3
ATC code: J05AX26
SMILES: Cc1cccc(C)c1N(CC(=O)Nc1ccc(-c2ncon2)cc1)C(=O)C1CCS(=O)(=O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: once daily

ASP2151: 200 mg once daily or 400 mg once daily
Eligibility criteria:
Inclusion Criteria:

(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

Exclusion Criteria:

Patients who are not expected to have an adequate response to oral antiviral medication
An extreme decline in immune function
Presence of serious complications

Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

AST or ALT ≥ 2.5 x upper limit of normal
Platelet count < lower limit of normal
Serum creatinine ≥ 1.5 mg/dL
Creatinine clearance < 50 mL/min
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression
Intervention: Amenamevir
Trial phase: Phase 3
ATC code: J05AX26
SMILES: Cc1cccc(C)c1N(CC(=O)Nc1ccc(-c2ncon2)cc1)C(=O)C1CCS(=O)(=O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: once daily

ASP2151: 200 mg once daily or 400 mg once daily
Eligibility criteria:
Inclusion Criteria:

(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

Exclusion Criteria:

Patients who are not expected to have an adequate response to oral antiviral medication
An extreme decline in immune function
Presence of serious complications

Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

AST or ALT ≥ 2.5 x upper limit of normal
Platelet count < lower limit of normal
Serum creatinine ≥ 1.5 mg/dL
Creatinine clearance < 50 mL/min
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression
Intervention: VALACYCLOVIR
Trial phase: Phase 3
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: 1000 mg three times daily

valaciclovir: 1000 mg three times daily
Eligibility criteria:
Inclusion Criteria:

(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

Exclusion Criteria:

Patients who are not expected to have an adequate response to oral antiviral medication
An extreme decline in immune function
Presence of serious complications

Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

AST or ALT ≥ 2.5 x upper limit of normal
Platelet count < lower limit of normal
Serum creatinine ≥ 1.5 mg/dL
Creatinine clearance < 50 mL/min
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression
Intervention: Fosphenytoin
Trial phase: Phase 3
ATC code: N03AB05
SMILES: O=C1NC(c2ccccc2)(c2ccccc2)C(=O)N1COP(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.

Fosphenytoin
Eligibility criteria:
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures
Intervention: VALPROIC ACID
Trial phase: Phase 3
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.

Valproic acid
Eligibility criteria:
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures
Intervention: Clopidogrel
Trial phase: Phase 2
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Continue home dose of clopidogrel into surgery
Eligibility criteria:
Inclusion Criteria:

taking clopidogrel
undergoing general surgery
cleared by both cardiologist and surgery for randomized arm

Exclusion Criteria:

previous history of bleeding complications/bleeding disposition
no capacity to consent
Intervention: Upadacitinib
Trial phase: Phase 2
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: ABT-494 3 mg twice daily (BID) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion Criteria:

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.