anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nicotine
Trial phase: Phase 2 | Phase 3
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.

Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs.
Eligibility criteria:
Inclusion Criteria:

18 years or older
planning to live in the Birmingham Metro area for the next 3 months
Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large >50% African-American average <10 cigarettes per day compared to Whites who average ~15 cigarettes per day
exclusive use of filtered cigarettes
English speaking.

Exclusion Criteria:

Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)
Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)
Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline
Known allergy nicotine lozenge
Within one month post-myocardial infarction or untreated severe angina
Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).
Intervention: Apremilast
Trial phase: Phase 3
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 298
Group description: Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
Eligibility criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
Subject must meet laboratory criteria.
Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.

2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).

5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.

8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

9. Subject had prior treatment with apremilast.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction

Bupivacaine: While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Eligibility criteria:
Inclusion Criteria:

All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
Age ≥ 18 years
Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.

Exclusion Criteria:

Patients who receive an autologous tissue reconstruction.
Patients who receive a unilateral reconstruction.
Patients who are expected to undergo axillary lymph node dissection
Patients who have undergone breast irradiation
Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
Patients who are wards of the state
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction

Liposomal Bupivacaine: While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Eligibility criteria:
Inclusion Criteria:

All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
Age ≥ 18 years
Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.

Exclusion Criteria:

Patients who receive an autologous tissue reconstruction.
Patients who receive a unilateral reconstruction.
Patients who are expected to undergo axillary lymph node dissection
Patients who have undergone breast irradiation
Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
Patients who are wards of the state
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.

Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
Eligibility criteria:
Inclusion Criteria:

Male or Female
Undergoing major laparoscopic colorectal procedure
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
ASA physical status Class I - III
Aged 18-90 years

Exclusion Criteria:

Refusal to participate in the study
Age <18 or > 90 years
Pregnancy

Contraindications to regional anesthetic including but not limited to:

Patient refusal to regional field blockade
Allergy
Infection at the site of needle insertion
Systemic infection
Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
Liver or renal disease (SCr > 1.5)
Chronic opioid use
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: 102
Group description: For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.

Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
Eligibility criteria:
Inclusion Criteria:

Male or Female
Undergoing major laparoscopic colorectal procedure
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
ASA physical status Class I - III
Aged 18-90 years

Exclusion Criteria:

Refusal to participate in the study
Age <18 or > 90 years
Pregnancy

Contraindications to regional anesthetic including but not limited to:

Patient refusal to regional field blockade
Allergy
Infection at the site of needle insertion
Systemic infection
Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
Liver or renal disease (SCr > 1.5)
Chronic opioid use
Intervention: Delgocitinib
Trial phase: Phase 2
ATC code: D11AH11
SMILES: C[C@H]1CN(C(=O)CC#N)[C@]12CCN(c1ncnc3[nH]ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Delgocitinib cream applied twice daily for 8 weeks

Delgocitinib cream: Cream for topical application
Eligibility criteria:
Key Inclusion Criteria:

Age 18 years and above.
Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
History of AD for ≥1 year.
AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

AD lesion(s) on scalp at screening and/or baseline.
Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
Use of tanning beds or phototherapy within 4 weeks prior to baseline.
Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
Receipt of live attenuated vaccines within 4 weeks prior to baseline.
Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
History of any active skin infection within 1 week prior to baseline.
Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Intervention: Delgocitinib
Trial phase: Phase 2
ATC code: D11AH11
SMILES: C[C@H]1CN(C(=O)CC#N)[C@]12CCN(c1ncnc3[nH]ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Delgocitinib cream applied twice daily for 8 weeks

Delgocitinib cream: Cream for topical application
Eligibility criteria:
Key Inclusion Criteria:

Age 18 years and above.
Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
History of AD for ≥1 year.
AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

AD lesion(s) on scalp at screening and/or baseline.
Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
Use of tanning beds or phototherapy within 4 weeks prior to baseline.
Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
Receipt of live attenuated vaccines within 4 weeks prior to baseline.
Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
History of any active skin infection within 1 week prior to baseline.
Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Intervention: Delgocitinib
Trial phase: Phase 2
ATC code: D11AH11
SMILES: C[C@H]1CN(C(=O)CC#N)[C@]12CCN(c1ncnc3[nH]ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Delgocitinib cream applied twice daily for 8 weeks

Delgocitinib cream: Cream for topical application
Eligibility criteria:
Key Inclusion Criteria:

Age 18 years and above.
Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
History of AD for ≥1 year.
AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

AD lesion(s) on scalp at screening and/or baseline.
Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
Use of tanning beds or phototherapy within 4 weeks prior to baseline.
Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
Receipt of live attenuated vaccines within 4 weeks prior to baseline.
Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
History of any active skin infection within 1 week prior to baseline.
Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Intervention: Desipramine
Trial phase: Phase 4
ATC code: N06AA01
SMILES: CNCCCN1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 4
Group description: Infantile neuroaxonal dystrophy (INAD) is an extremely rare autosomal recessive neurodegenerative disorder that has grave clinical outcome and significant morbidity and mortality.

Desipramine: Study drug (desipramine) provided in tablet form to be taken daily.
Eligibility criteria:
Inclusion Criteria:

03-17years.
Any gender
Confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in PLA2G6
Confirmed homozygotes of pathogenic mutation in PLA2G6
Documentation of clinical presentation (signs and symptoms of neurodegenerative process) of INAD

Exclusion Criteria:

Patient has sign and symptom suggesting an ongoing acute or chronic illness such as fever of unknown origin or infection.
Patient has a second genetic condition
Parents are unable or unwilling to return for continued care for up to 12 months
Intervention: Gusacitinib
Trial phase: Phase 2
SMILES: N#CCC1CCN(c2nc(Nc3ccc(N4CCC(O)CC4)cc3)c3c(=O)[nH]ncc3n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 40 mg ASN002

ASN002: Daily dose of ASN002 for 32 weeks
Eligibility criteria:
Inclusion Criteria:

Written informed consent obtained prior to any study-related procedure being performed
Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
Subject has a history of severe CHE for at least 6 months prior to baseline
Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.
Subject has been using an emollient on their hands and feet (except those containing urea or salicylic acid) every day at the same frequency for at least 1 week prior to Day 1
Subject has a body mass index (BMI) ≤ 38 kg/m2.
Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
Willing and able to comply with clinical visits and study related procedures.

Exclusion Criteria:

Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
A serious uncontrolled condition including hypertension, active tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer.
Active skin infections of the hands and/or feet
Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
Pregnant or breast-feeding women
Known hypersensitivity to ASN002 or its excipients
Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.