anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Umibecestat
Trial phase: Phase 2 | Phase 3
SMILES: CC1(c2nc(NC(=O)c3ncc(C(F)(F)F)cc3Cl)ccc2F)COC(C)(C(F)(F)F)C(N)=N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 455
Group description: 50 mg capsule taken orally once daily
Eligibility criteria:
Inclusion Criteria:

consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
Cognitively unimpaired as evaluated by memory tests performed at screening.
Participant's willingness to have a study partner.
Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

Exclusion Criteria:

Any disability that could have prevented the participants from completing all study requirements. -
Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
History of malignancy of any organ system, treated or untreated, within the past 60 months.
Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
Contraindication or intolerance to MRI.
Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring.
Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.
A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse.
Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
Current clinically significant ECG findings.
Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year.
Intervention: Umibecestat
Trial phase: Phase 2 | Phase 3
SMILES: CC1(c2nc(NC(=O)c3ncc(C(F)(F)F)cc3Cl)ccc2F)COC(C)(C(F)(F)F)C(N)=N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 233
Group description: 15 mg capsule taken orally once daily
Eligibility criteria:
Inclusion Criteria:

consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
Cognitively unimpaired as evaluated by memory tests performed at screening.
Participant's willingness to have a study partner.
Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

Exclusion Criteria:

Any disability that could have prevented the participants from completing all study requirements. -
Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
History of malignancy of any organ system, treated or untreated, within the past 60 months.
Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
Contraindication or intolerance to MRI.
Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring.
Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.
A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse.
Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
Current clinically significant ECG findings.
Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
patients with Type 2 diabetes, HbA1c <10% at screening.
Body mass index (BMI) ≤ 50 kg/m^2 at screening.

Exclusion Criteria:

Patients with Type 1 diabetes
Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
Patients undergoing any method of dialysis
clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
patients with Type 2 diabetes, HbA1c <10% at screening.
Body mass index (BMI) ≤ 50 kg/m^2 at screening.

Exclusion Criteria:

Patients with Type 1 diabetes
Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
Patients undergoing any method of dialysis
clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
patients with Type 2 diabetes, HbA1c <10% at screening.
Body mass index (BMI) ≤ 50 kg/m^2 at screening.

Exclusion Criteria:

Patients with Type 1 diabetes
Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
Patients undergoing any method of dialysis
clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
patients with Type 2 diabetes, HbA1c <10% at screening.
Body mass index (BMI) ≤ 50 kg/m^2 at screening.

Exclusion Criteria:

Patients with Type 1 diabetes
Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
Patients undergoing any method of dialysis
clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
patients with Type 2 diabetes, HbA1c <10% at screening.
Body mass index (BMI) ≤ 50 kg/m^2 at screening.

Exclusion Criteria:

Patients with Type 1 diabetes
Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
Patients undergoing any method of dialysis
clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Intervention: Imatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EA01 | L01XE01
SMILES: Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.

Imatinib Mesylate 400Mg Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
Eligibility criteria:
Inclusion Criteria:

Definite or Probable LAM
FVC or Postbronchodilator FEV1 <90% predicted

Exclusion Criteria:

Current or planned pregnancy or lactation
Unwillingness to discontinue sirolimus
Change in the dose or use of sirolimus within the past month
Inability to perform spirometry
Allergy or intolerance of albuterol and/or ipratropium
Other serious illness that would impact the outcome of the study including cancer that has not received curative therapy, Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study), uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection
Current lung transplant
Known diagnosis of human immunodeficiency virus (HIV) infection
Current cigarette smoking
Required use of warfarin, ketoconazole, itraconazole, clarithromycin, or rifampin during the 2 months of the study.
Unwillingness to avoid grapefruit juice or St. Johns Wort during the study.
Planned surgery during the 2 months of the study.
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Patient has received and other investigational agents within 28 days of first day of study drug dosing.
Intervention: Morphine
Trial phase: Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)

Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Eligibility criteria:
Methadone Treatment Group:

Inclusion criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Mother under the care of Operation PAR;
Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
Mother has been deemed by PAR officials as being compliant with the detoxification program;
Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
Mother with hearing or language impairment

Comparison Group:

Inclusion Criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Infant not requiring pharmacologic treatment for NAS;
Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Mother with hearing or language impairment;
Infants known upon admission who will be placed into state custody or sheltered.
Intervention: Zinc Acetate
Trial phase: Phase 2
ATC code: A16AX05 | C05AX04
SMILES: CC(=O)[O-].CC(=O)[O-].[Zn+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)

Zinc Acetate 50 Mg Oral Capsule: • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)

Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)
Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)
Eligibility criteria:
Inclusion Criteria:

No upper or lower respiratory infection within 4 weeks

Either

Negative evaluation for:

Asthma; no symptoms of disease or no evidence of asthma based on spirometry and/or methacholine challenge test
GERD: no symptoms of acid reflux disease or negative potential of hydrogen (pH) probe
Rhinosinusitis/upper airway cough

Or

Cough persists despite treatment for the following:

Asthma -treated for at least 8 weeks with at least medium dose inhaled corticosteroids or with oral corticosteroids
GERD - treated for at least 8 weeks with either a proton pump inhibitor (PPI) or H2 blocker

Upper airway disease, postnasal drip or sinusitis - treated for at least 8 weeks with nasal steroids, antihistamines or both.

Non-smoker; defined as
no smoking of any substance (e.g., tobacco, e-cigarette, marijuana) in the past 6 months, and

less than 20 pack-year smoking history

Chest x-ray or CT scan in the past 12 months; negative for parenchymal lung diseases (such as interstitial lung disease, idiopathic pulmonary fibrosis, pneumonia, or TB) and negative for lung cancer
Overall Cough Visual Analog Scale (Cough-VAS) score of 30 or higher
Willing to halt use of zinc supplements or multivitamins containing zinc for the duration of the study
Provide written informed consent

Exclusion Criteria:

Marijuana use (smoking or ingestion of marijuana) in the past 6 months
Use of ACE inhibitor currently or within the past 6 weeks
Use of zinc supplements or multivitamins containing zinc currently or within the past 6 weeks
Occupational exposure to dust or chemicals that may cause cough, as determined by study physician
Diagnosis or evidence of chronic obstructive pulmonary disease (COPD) as defined by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.70 and FEV1% predicted < 80%

History of lung disease, such as:

Bronchiectasis
Interstitial lung disease
Sarcoidosis
Pneumoconiosis
Asbestosis
Chronic mycobacterial infection
Lung cancer
History of pancreatitis
Congestive heart failure
Chronic kidney disease (creatinine clearance < 30ml/min)
Pregnant or breast-feeding
Other medical conditions that would interfere with participation in study
Intervention: Digoxin
Trial phase: Phase 4
ATC code: C01AA05
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@@H](C5=CC(=O)OC5)CC[C@@]43O)[C@@]1(C)CC[C@H](O[C@H]1C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O[C@H]4C[C@H](O)[C@H](O)[C@@H](C)O4)[C@@H](C)O3)[C@@H](C)O1)C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 86
Group description: Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance

Digoxin: Trans-abdominal injection
Eligibility criteria:
Inclusion Criteria:

20 weeks 0 days-24 weeks 0 days gestation
English or Spanish speaking
18 years or older

Exclusion Criteria:

Under 18
Contraindications to digoxin
Intervention: Dotatate gallium Ga-68
Trial phase: Phase 3
SMILES: C[C@@H](O)[C@H](NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@@H](Cc2ccccc2)NC(=O)CN2CCN(CC(=O)[O-])CCN(CC(=O)[O-])CCN(CC(=O)[O-])CC2)C(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@H](Cc2c[nH]c3ccccc23)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1)C(=O)O.[68Ga+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent.
Patients of either gender, aged ≥18 years.
Karnofsky status ≥60.
Life expectancy of at least 12 weeks.
Histologically and/or clinically confirmed and/or suspicious of NET.
A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.

Recent Blood test results up to 4-6 weeks as follows:

White Blood Cell (WBC): >2*109/L
Haemoglobin: >8.0g/Dl
Platelets: >50x109/L
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
Bilirubin less than, or equal to, three times its ULN
Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.
Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
Pregnant or breast-feeding women.
Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
Intervention: Olanzapine
Trial phase: Phase 2 | Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age
Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
Have not received chemotherapy or radiation for >14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration
Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration
Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration.

Exclusion Criteria:

Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
Not have concurrent use of ethyol
Not have severe cognitive compromise
History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
Chronic alcoholism (as determined by the investigator)
Known hypersensitivity to olanzapine
Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
Planned chemotherapy or radiation during the 7 days following study initiation.
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
Clinical lab results within the normal range

Exclusion Criteria:

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
Treatment with systemic immunosuppressive medications or biologics.
Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study