anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Triamcinolone
Trial phase: Phase 4
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.

Triamcinolone 0.1%: Topical ointment
Eligibility criteria:
Inclusion Criteria:

Male or female patients 18-75 years of age
AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been present for at least 1 year
History of inadequate response to a stable regimen of TCS for 1 month (in the 3 months immediately preceding the screening visit) as treatment for their AD
Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and baseline visits
≥10% body surface area involvement by AD

A washout period prior to screening for those patients who have previously received the following medications:

Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic immunosuppressants: 4 weeks
Phototherapy: 4 weeks
Biologics: 5 half lives of the drug

Exclusion Criteria:

Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)
Use of topical calcineurin inhibitors within 4 weeks of screening
Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCS product used during the study
Evidence of active skin infection at screening or baseline visit
Evidence or history of active or latent infections such as tuberculosis or hepatitis C
Patient clinical condition is not appropriate for treatment with protocol prescribed TCS
Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
Use of a tanning booth/parlor within 4 weeks before the baseline visit
Use of any anti-histamine medication within 4 weeks before the baseline visit.
History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
Other clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study or to impact the study pharmacodynamic (PD), or safety assessments
Unwillingness or inability to comply with the study protocol for any other reason.
Intervention: Pafolacianine
Trial phase: Phase 2
ATC code: V04CX10
SMILES: CC1(C)C(=CC=C2CCCC(C=CC3=[N+](CCCCS(=O)(=O)O)c4ccc(S(=O)(=O)[O-])cc4C3(C)C)=C2Oc2ccc(CC(NC(=O)c3ccc(NCc4cnc5nc(N)[nH]c(=O)c5n4)cc3)C(=O)O)cc2)N(CCCCS(=O)(=O)O)c2ccc(S(=O)(=O)O)cc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

OTL38

Near infrared camera imaging system: Near infrared camera imaging system

Laparotomy: primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Eligibility criteria:
Inclusion Criteria:

Female patients 18 years of age and older

Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:

Who are scheduled to undergo laparotomy for the debulking surgery OR
Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

Previous exposure to OTL38
Known FR alpha-negative ovarian cancer
Planned surgical approach via laparoscopy or robotic surgery
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
History of anaphylactic reactions or severe allergies
History of allergy to any of the components of OTL38, including folic acid
Pregnancy, or positive pregnancy test
Clinically significant abnormalities on electrocardiogram (ECG)
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as eGFR< 50 mL/min/1.73m2
Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
Known Stage IV ovarian cancer with Brain Metastases
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
Known sensitivity to fluorescent light
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
Onset of pancreatitis within <=2 weeks
complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria:

SAP complicated by Gastrointestinal bleeding or Intestinal fistula
Pregnancy and lactation women
Not signed the informed consent
Diabetes and autoimmune diseases
Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

Exclusion Criteria:

Inadequate supervision by parent(s)/caregiver(s)
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
the analysis of results
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

Exclusion Criteria:

Inadequate supervision by parent(s)/caregiver(s)
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
the analysis of results
Intervention: Cannabidiol
Trial phase: Phase 3
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.

The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

Exclusion Criteria:

Inadequate supervision by parent(s)/caregiver(s)
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
the analysis of results
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
Eligibility criteria:
Inclusion Criteria:

Japanese participants with a diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

History of Type 1 diabetes mellitus or ketoacidosis
History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation
Intervention: Glyburide
Trial phase: Phase 4
ATC code: A10BB01
SMILES: COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
Eligibility criteria:
Inclusion Criteria:

Japanese participants with a diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

History of Type 1 diabetes mellitus or ketoacidosis
History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation
Intervention: Sarecycline
Trial phase: Phase 3
ATC code: J01AA14 | J01AA20
SMILES: [H][C@@]12Cc3c(CN(C)OC)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 481
Group description: Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent or assent form
Male/female, 9 to 45 years of age, inclusive
Body weight between 33 and 136 kg, inclusive
Facial acne vulgaris with:
20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
No more than 2 nodules
IGA score of moderate (3) or severe (4)
Negative urine pregnancy test at baseline - females of childbearing potential
Agrees to use an effective method of contraception throughout the study
Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)

Exclusion Criteria:

Has a dermatological condition of the face that could interfere with the clinical evaluations
Has a history of any of the following:
Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
Pseudomembranous colitis or antibiotic associated colitis
Treated for any type of cancer within the last 6 months
Has known resistance to other tetracyclines
Has received any of the following treatments within 12 weeks of screening:
Systemic retinoids
Systemic corticosteroids
Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
Has used any acne affecting treatment without an appropriate washout period
Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
Is pregnant, lactating or planning a pregnancy during the study period
Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
Has drug-induced acne
Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
Has previously participated in any clinical trial involving the use of sarecycline
Is judged by the Investigator to be unsuitable for any reason
Intervention: Desloratadine
Trial phase: Phase 3
ATC code: R06AX27
SMILES: Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.

Exclusion Criteria:

Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
Has asthma that is under treatment and/or uncontrolled
Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
Has vasomotor rhinitis or eosinophilic rhinitis
Has a history of hypersensitivity to antihistamines or ingredients of study drug
Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs [injectable]) or immunological drugs within 28 days prior to Visit 2
Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
Will receive nasal nebulizer therapy and/or thermotherapy during study period
Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
Has a history of severe drug allergy (e.g. anaphylactoid reaction)
Is pregnant or lactating or may be pregnant
Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.
Intervention: Liothyronine
Trial phase: Phase 3
ATC code: H03AA02 | H03AA03
SMILES: NC(Cc1cc(I)c(Oc2ccc(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 110
Group description: Active Medication - Synthetic Thyroid Hormone

Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained
Male and female patients <5 months (152 days) of age
Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
Trisomy 13 and 18
Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
Prior participation in the clinical trial
Intervention: Eritoran
Trial phase: Phase 2
SMILES: CCCCCC/C=C\CCCCCCCCCC(=O)N[C@H]1[C@H](OC[C@H]2O[C@H](OP(=O)(O)O)[C@H](NC(=O)CC(=O)CCCCCCCCCCC)[C@@H](OCCCCCCCCCC)[C@@H]2O)O[C@H](COC)[C@@H](OP(=O)(O)O)[C@@H]1OCC[C@@H](CCCCCCC)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: IV administration of Eritoran 12 mg every 12 hours plus Intralipid infusion at a rate of 30 ml/hour

Eritoran: Eritoran = E5564 Eritoran is a pharmacologic inhibitor of TLR4.
Eligibility criteria:
Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2)
normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Presence of diabetes or impaired glucose tolerance based on ADA criteria;
Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.