anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Lotion

IDP-118 Lotion: Lotion
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Intervention: Nitrite
Trial phase: Phase 4
SMILES: O=N[O-]
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Nitrite: 20mg pill, three times daily for 5 days

Nitrite
Eligibility criteria:
Inclusion Criteria:

healthy,
young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in < 15 min 54 s)

Exclusion Criteria:

women;
smokers;
participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
participants with a history of significant head injury, migraines or seizures;
participants taking any medication (over-the-counter or prescription) or herbal supplements;
participants with known flavonoid allergies;
participants with known allergies to metformin;
participants with known hypersensitivity reaction to nifedipine;
participants with known allergies to sulfonamide-based drugs;
participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
exposure to high altitude above 1000m in the previous three months; or
participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
participants who are unable to achieve the minimum physical criteria required for SOF training
Intervention: Theophylline
Trial phase: Phase 2
ATC code: R03DA04 | R03DA20 | R03DA54 | R03DA74 | R03DB04
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients will receive a 24 hour continuous infusion of intravenous theophylline.

Theophylline: 24 hour infusion of IV theophylline. All patients who enrolled in the study are included in this group (excluding screen fails).
Eligibility criteria:
Inclusion Criteria:

Age 10 to 21 years old
English proficiency
Clinical and genetic diagnosis of PHP1a

Exclusion Criteria:

Use of a PDE inhibitor in the past 30 days
History of a seizure disorder unrelated to hypocalcemia
History of a cardiac arrhythmia (not including bradycardia)
History of hepatic insufficiency
AST or ALT >2x upper limit of normal
Total bilirubin >1.5 x upper limit of normal (unless patient has a diagnosis of Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified)
Congestive heart failure
Cigarette use in the past 30 days
Alcohol use within the past 24 hours
Current pregnancy
Untreated hypothyroidism (defined as free T4 level < 0.6 ng/dL or TSH >10 mcU/mL)
Active peptic ulcer disease
Fever >101 degrees in the past 24 hours
Current use of medications known to effect theophylline levels (listed below)
Severe sleep apnea requiring BiPAP

Drugs with clinically significant drug interactions with theophylline:

Allopurinol
Cimetidine
Ciprofloxacin
Clarithromycin
Enoxacin
Ephedrine
Erythromycin
Estrogen
Flurazepam
Fluvoxamine
Lithium
Lorazepam
Methotrexate
Midazolam
Pentoxifylline
Propranolol
Rifampin
Sulfinpyrazone
Tacrine
Thiabendazole
Ticlopidine
Troleandomycin
Verapamil
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks

Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-65 who are current or former smokers
Serum calcium<10.5mg/dL
25-Hydroxy Vitamin D (OHD)<20 ng/mL
Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation
Women of reproductive potential with negative serum or urine pregnancy test and subjects must refrain from participating in a conception process and subject/partner must use at least 2 reliable forms of contraceptives for the duration of the study
For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than 50% predicted.
For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

Exclusion Criteria:

Current use of vitamin D supplements
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
Pregnancy or currently breast-feeding
History of nephrolithiasis
HIV positive serostatus
Continuous oxygen use >2 liters/min via nasal cannula
Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Eligibility criteria:
Inclusion Criteria:

Written informed consent
Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
Abide by study restrictions
Acceptable birth control measures
Ability to attend all study visits
Vital signs as per protocol
Willing to consume high calorie meals within designated time frame

Exclusion Criteria:

Clinically significant medical history
Clinically significant abnormal findings
History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
Has smoked or used tobacco products within 60 days prior to the first dose of study medication
Has donated blood or plasma within 30 days prior to the first dose of study medication
Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Eligibility criteria:
Inclusion Criteria:

Written informed consent
Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
Abide by study restrictions
Acceptable birth control measures
Ability to attend all study visits
Vital signs as per protocol
Willing to consume high calorie meals within designated time frame

Exclusion Criteria:

Clinically significant medical history
Clinically significant abnormal findings
History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
Has smoked or used tobacco products within 60 days prior to the first dose of study medication
Has donated blood or plasma within 30 days prior to the first dose of study medication
Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
Intervention: Acetazolamide
Trial phase: Phase 2
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Acetazolamide in oral daily divided dose administered for 6 consecutive months

Acetazolamide: see arm description
Eligibility criteria:
Inclusion Criteria:

Diagnosis of relapsing forms of multiple sclerosis using revised McDonald criteria
Stable on any FDA-approved disease-modifying therapy. The term "stable" implies that the subject has not had change in therapy for any reason for the 6 months prior to study entry.
Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
Understood and signed written informed consent, obtained prior to the study subject undergoing any study related procedure, including screening tests.

Exclusion Criteria:

Known hypersensitivity to sulfonamides or derivatives
Known history of renal or hepatic disease, cerebrovascular disease including stroke, transient ischemic attack, myocardial infarction, angina or congestive heart failure.
Evidence to suggest hyponatremia or hypokalemia, marked kidney dysfunction defined as creatinine greater than 2.0 mg/dL or liver disease dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three-fold upper limit of normal (ULN).
Evidence to suggest suprarenal gland failure.
Evidence of hyperchloremic acidosis.
Initiation of new immunosuppressant treatment after the subject becomes protocol-eligible (except for corticosteroids) or enrollment in a concurrent trial.
Prior treatment with mitoxantrone, natalizumab, methotrexate, cladribine cyclophosphamide or other change in disease modifying therapy (DMT) within 6 months of initiation of study.
Subjects with any history of cytopenia.
History of pulmonary obstruction or emphysema.
Active hepatitis B or hepatitis C infection or evidence of cirrhosis.
Human immunodeficiency virus (HIV) positivity.
Uncontrolled diabetes mellitus defined as HbA1c>8% and/or requiring intensive management.
Uncontrolled viral, fungal, or bacterial infection (excluding asymptomatic bacteriuria).
Any condition that, in the opinion of the investigators, would jeopardize the ability of the subject to tolerate treatment with ACZ.
Prior history of malignancy.

Positive pregnancy test or inability or unwillingness to use effective means of birth control. Effective birth control defines as:

Refraining from all acts of vaginal intercourse (abstinence)
Consistent use of birth control pills
Tubal sterilization or male partner who has undergone vasectomy
Placement of an intrauterine device (IUD)
Use, with every act of intercourse, of a diaphragm with contraceptive jelly and/or condoms with contraceptive foam
Presence of metallic objects implanted in the body that would preclude the ability of the subject to safely have MRI exams.
Psychiatric illness, mental deficiency, or cognitive dysfunction making compliance with treatment of informed consent impossible.
Intervention: LENABASUM
Trial phase: Phase 2
SMILES: [H][C@@]12CC(C(=O)O)=CC[C@@]1([H])C(C)(C)Oc1cc(C(C)(C)CCCCCC)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.

JBT-101: Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.
Eligibility criteria:
Inclusion Criteria (Part A):

CDASI activity score ≥ 14;
No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase;
Failed at least 3 months treatment with hydroxychloroquine;
Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1).

Inclusion Criteria (Part B):

Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons

Exclusion Criteria (Part A and B):

Significant diseases or conditions other than DM that may influence response to the study product or safety;

Any one of the following values for laboratory tests at Screening:

A positive pregnancy test (or at Visit 1);
Hemoglobin < 10 g/dL;
Neutrophils < 1.0 x 10^9/L;
Platelets < 75 x 10^9/L;
Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit;
Total bilirubin ≥ 1.5 x upper limit of normal.
Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Intervention: 4-[(3R,4S,5R)-4-amino-3,5-dihydroxyhex-1-ynyl]-5-fluoro-3-[(3-methoxy-1H-pyrrol-2-yl)methyl]indol-2-one
Trial phase: Phase 4
SMILES: COc1cc[nH]c1CC1=c2c(C#CC(O)C(N)C(C)O)c(F)ccc2=NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
Eligibility criteria:
Inclusion Criteria:

No systemic diseases that could influence the outcome of the therapy
No smoking
No medications affecting periodontal tissues
No pregnancy or lactation
Presence of at least 15 teeth

Exclusion Criteria:

Received antibiotic treatment in the previous 3 months
Smokers
Pregnancy and lactation
Received periodontal treatment in the previous 6 months
Presence of less than 15 teeth
Presence of systemic diseases
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.

All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.

Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan
Eligibility criteria:
Inclusion Criteria:

Inpatients scheduled for CT scan of abdomen and/or pelvis
Had surgery in the last 4 weeks
Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT)
Suspected infection or fluid collection in abdomen and/or pelvis

Exclusion Criteria:

Pregnant
Severe Allergy (anaphylaxis) to contrast
Dialysis in last 7 days
Received intravascular iodinated contrast in last 48 hours
CT of abdomen and pelvis in last 7 days shows no fluid collection
Prisoners
CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Linagliptin 5mg once daily for 12 weeks

Linagliptin: 5 mg tablet once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Adults aged 30-70 years
Diagnosis of type 2 diabetes within the previous 15 years using criteria of the American Diabetes Association
Currently being treated with 1-2 grams/day of metformin, or insulin or both stably
Hemoglobin A1c (HbA1C) between 6.5% to 10.0% (both inclusive)
Body Mass Index (BMI) between 25 and 39.9 kg/m2 (both inclusive)
Chronic Kidney disease (CKD) Stages 1-3, Creatinine clearance (CrCl) less than 90 and more than 29

Exclusion Criteria:

Type 1 diabetes
History of Diabetic Ketoacidosis (DKA) or hyperosmolar nonketotic coma
Hemoglobinopathies with low hematocrit (Below 28 Units)
History of pancreatitis
History of cancer within the past 5 years (except basal cell carcinoma)
Previous cardiovascular or cerebrovascular event within 6 months of screening or active or clinically significant coronary and/or Peripheral Vascular Disease (PVD)
Statin use started in the last 3 month
Current use of oral or injectable anti-diabetic medication other than Metformin and insulin
Consistent use of steroids within the last 3 months
Any active wounds, or surgery within the past 3 months
Inflammatory disease, or the chronic use of anti-inflammatory drugs within the past 3 months
Untreated hyper/hypothyroidism
Contraindications to moderate exercise
Implanted devices that might interact with the tanita scale
Pre-existing liver disease and/or Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) > 2.5 times Under the Normal Limits (UNL)
Untreated Systolic blood pressure > 140 mmHg or diastolic blood pressure> 90 mmHg
Serum creatinine levels ≥ 2.0
CKD Stages 4 and 5 (estimated CrCl <30 mL/min)
Triglycerides > 450 mg/dL
Known allergies or hypersensitivities to Linagliptin or Dipeptidyl peptidase-4 (DDP-4) inhibitors
Treatment with cytochrome p450 (CYP 3A4) inhibitors
Women of child bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
Prisoners or subjects that are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
Additionally, patients who are active smokers, patients who are pregnant, nursing women, and post-menopausal women who are on hormone replacement therapy will be excluded.
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: TCA IR: Single 3 mL IA injection
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female ≥20 and ≤50 years of age
Diagnosis of post-traumatic OA of the knee
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications and therapies during the study

Exclusion Criteria:

Prior osteotomy of the index knee
Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain)
Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
History of, or clinical signs and symptoms of active infection of the index knee
Crystal disease of the index knee within one month of Screening
Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
Type 1 or Type 2 diabetes requiring insulin
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Furosemide
Trial phase: Phase 2
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 46
Group description: Furosemide 1 dose

Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Acute Bronchiolitis
Admission required per Emergency Department Physician

Exclusion Criteria:

No legal guardian present
Sulfa allergy
Patient currently on existing diuretic therapy
Tracheostomy
Mild respiratory distress (not requiring admission)
Hypotension / Hemodynamic Instability (defined by age specific criteria at time of intervention)
Supplemental Oxygen at home
History of Dialysis / Renal Disease
Those enrolled in another drug interventional study
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: 44
Group description: LIK066 150 mg qd within 15 minutes before starting lunch
Eligibility criteria:
Key Inclusion Criteria:

Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6 mmol/L), or HbA1c > 5.7% and < 10% at screening.
Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening

Key Exclusion Criteria:

Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders
Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption
Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder
Pregnant or nursing (lactating) women, and women of child-bearing potential