anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Salsalate
Trial phase: Phase 2
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).

Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Eligibility criteria:
Inclusion Criteria:

Type 1 diabetes (T1D)
Peripheral neuropathy with symptoms of pain, or with other uncomfortable symptoms (e.g., burning, prickling).
18 to 70 years old
Stable insulin treatment program for at least the past 3 months.
Abnormal nerve conduction studies (based on study screening examination)
Willing and able to take an oral (by mouth) medication 3 times per day for 3 months.
WOMEN using an appropriate method of contraception during the course of the study (hormonal, IUD, or diaphragm.
Willing and able to provide written informed consent for study participation.

Exclusion Criteria:

Neuropathy from a cause other than diabetes.
Allergy to salsalate or similar medications (aspirin, non-steroidal anti-inflammatory medicines like ibuprofen and naproxen).
Currently on blood thinning agents such as Coumadin, Heparin, Plavix, Pradaxa, high-dose aspirin (more than 325 mg daily).
Any severe low blood sugar episodes in the past 6 months (needed assistance to treat).
Diabetic ketoacidosis in the past 6 months.
Severe neuropathy, or have had an ulcer or amputation on either foot or either leg.
Creatinine level (a measure of kidney function is greater than 1.4 mg/dl (for women) or greater than 1.5 mg/dl (for men) or your estimated GFR is under 60.
Albumin in your urine or other signs of reduced kidney function.
Liver enzymes (including ALT, AST and Bilirubin) levels are more than 2 and ½ times the upper limit of normal.
Blood platelets are less than 100,000 at the time of screening.
Organ transplant (lung, kidney, heart, pancreas, liver).
Chronic immunosuppressive therapy, for example, daily prednisone or other steroids, methotrexate, Imuran, CellCept. This includes daily, or recurrent use of oral steroids used to treat asthma.
Regular NSAID medications (e.g., Naproxen, Ibuprofen) use. If used occasionally, you will be asked to not use them during the study.
History of drug or alcohol abuse, or if you take more than 10 alcoholic drinks per week.
History of stomach ulcers or bleeding from your bowel.
Heart attack, heart bypass surgery, heart failure or a stroke EVER.
Current treatment for any cancer (other than basal cell or squamous cell skin cancer).
Treatment with lithium.
Ever had Reyes' syndrome.
Pregnant, nursing, or planning to become pregnant during the time of the study.
Allergic to lidocaine or epinephrine (used for numbing skin prior to biopsies).
Keloid scarring in the past.
Receiving other experimental treatments.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
Eligibility criteria:
Inclusion Criteria:

Sickle Cell Disease
Ages 3 years - 21 years

Exclusion Criteria for Enrollment:

Pregnancy
Known allergy to Fentanyl
Usage of daily home opiates

Exclusion Criteria at presentation in ED with a painful crisis:

Wong Baker FACES Pain Score <6
Systolic blood pressure < 5 percentile for age
Oxygen saturation <92% on room air
Temperature > 102°F
Respiratory distress
Priapism
Isolated abdominal pain
Isolated headache
New neurological symptoms
Severe rhinorrhea or epistaxis
History of trauma
Pregnancy
Intervention: Fentanyl Citrate
Trial phase: Phase 4
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
Eligibility criteria:
Inclusion Criteria:

Sickle Cell Disease
Ages 3 years - 21 years

Exclusion Criteria for Enrollment:

Pregnancy
Known allergy to Fentanyl
Usage of daily home opiates

Exclusion Criteria at presentation in ED with a painful crisis:

Wong Baker FACES Pain Score <6
Systolic blood pressure < 5 percentile for age
Oxygen saturation <92% on room air
Temperature > 102°F
Respiratory distress
Priapism
Isolated abdominal pain
Isolated headache
New neurological symptoms
Severe rhinorrhea or epistaxis
History of trauma
Pregnancy
Intervention: Eltrombopag
Trial phase: Phase 2
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Administration of eltrombopag to support platelets during chemotherapy

Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy
Eligibility criteria:
Inclusion Criteria:

Participants must have histologically confirmed multiple myeloma that is relapsed or refractory
Patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
Performance status (ECOG) ≤ 2
Not pregnant or breastfeeding

Exclusion Criteria:

Participants with a history of rapidly progressive disease [increase in tumor size (≥ 50%) as defined by standard myeloma markers ], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days
Participants may not be receiving any other study agents within 21 days prior to entry on the study.
The use of growth factors other than erythropoiesis stimulating agents or G-CSF (Neupogen or Neulasta) during the study period.
Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, AT-III deficiency, etc.), platelet disorder or bleeding disorder.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Intervention: Budesonide
Trial phase: Not Applicable
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids.

Budesonide: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Eligibility criteria:
Group A:

Inclusion Criteria:

Male and female subjects between the ages of 18 and 70 years

Group B:

Inclusion Criteria:

Male and female subjects between the ages of 18 and 70 years
History of asthma
No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6 weeks
Hyperreactivity to methacholine (PC20FEV1 Methacholine ≤ 8.0 mg/mL)

At least one of the following symptoms, beta agonist use, or FEV1 criteria:

Asthma symptoms on at least two days per week; OR
Beta agonist use on at least two days per week; OR
FEV1 < 85% predicted

Groups A & B:

Exclusion Criteria:

Current smokers (smoking within the last 12 months) or former smokers who have a total pack-year smoking history greater than 10
Pregnant women
Subjects with a history of lung disease other than asthma
Subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
Intervention: EXENATIDE
Trial phase: Phase 2
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: exenatide 10 mcg twice daily
Eligibility criteria:
Inclusion Criteria:

Age 18 to 40 years old
History of craniopharyngioma or other lesion in the hypothalamic region
Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
BMI >30 mg/m2
Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks

Exclusion Criteria:

HgbA1C >7%
Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
Use of weight loss drugs or initiation of a weight loss program in past 3 months
Impaired renal function or history of kidney transplant
History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
Personal or family history of medullary carcinoma of the thyroid or MEN type 2
History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
History of allergic reaction to exenatide or other medication components
Other significant comorbidities other than pituitary deficiencies
Currently prescribed warfarin (exenatide may alter warfarin metabolism)
Pregnant or lactating females
History of severe hypoglycemia (BG <60 and requiring assistance from another person)
Intervention: Nevirapine
Trial phase: Phase 2
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.

Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.
Eligibility criteria:
Inclusion Criteria:

Any patient with either progressive aGvHD or Steroid Refractory aGvHD after Bone marrow transplant
Prophylactic GvHD therapy with cyclosporine, tacrolimus, MMF, or sirolimus can be continued.
Patients with late onset acute GvHD will be eligible
Patients should have an absolute neutrophil count (ANC) of >500µL
Patients with renal dysfunction or veno-occlusive disease are eligible

Exclusion Criteria:

Patient should not be getting any other experimental therapy for aGvHD
Patients with active uncontrolled life threatening infection (s) from viral, bacterial, fungal or other organisms will be excluded. Patients with HIV infection will be excluded
Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
Patients with NYHA Class III or IV heart failure will be excluded
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Eligibility criteria:
Inclusion Criteria:

Age: 1-18 months.

Hospitalization for the first episode of RSV bronchiolitis:

Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).
Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).

Willingness to provide informed consent by the child's parent or guardian

-

Exclusion Criteria:

Prematurity (gestational age < 36 weeks).
Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
History of previous (before the current episode) wheeze or previous treatment with albuterol.
Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
Treatment with any antibiotics in the past 2 weeks.
Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
Participation in another clinical trial.
Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
Contraindication of use of azithromycin or any other macrolide antibiotics.
Intervention: Birinapant
Trial phase: Phase 1 | Phase 2
SMILES: CC[C@H](NC(=O)[C@H](C)NC)C(=O)N1C[C@@H](O)C[C@H]1Cc1c(-c2[nH]c3cc(F)ccc3c2C[C@@H]2C[C@H](O)CN2C(=O)[C@H](CC)NC(=O)[C@H](C)NC)[nH]c2cc(F)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle

Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Eligibility criteria:
Inclusion criteria

Subjects with a diagnosis of non-M3 AML, Relapsed or refractory ALL or Intermediate Risk 2 or High Risk disease MDS as follows:

Subjects with a diagnosis of non-M3 AML which meets one of the following criteria:

Ages 60 or older: Relapsed or refractory after at least one prior therapy for AML
Ages 60 or older: Newly diagnosed in a patient with a preceding history of myelodysplastic syndrome which has been treated with azacitidine or decitabine and who are not appropriate candidates for aggressive therapy including induction followed by allogeneic stem cell transplantation
Ages 18-59: Relapsed or refractory disease after failing three prior lines of therapy
Subjects with a diagnosis of relapsed or refractory ALL: must have failed three prior lines of therapy and be 18 years of age or older.

Subjects with a diagnosis of Intermediate Risk 2 or High Risk disease (as defined by IPSS score):

Must have failed to respond/intolerant to, or progressed after a hypomethylating agent, and must not be candidates for allogeneic stem cell transplantation
Life expectancy of at least 4 weeks
Must have recovered from toxic effects of prior chemotherapy
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.

Exclusion criteria

Cytotoxic chemotherapy (including azacitidine or decitabine) within the past 28 days other than hydroxyurea
Active participation in any other investigational treatment study for AML.
ECOG performance status greater than 2
Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
QT interval corrected for heart rate (QTcB) greater than 480 msec (including subjects on medication). Subjects with a ventricular pacemaker for whom QT interval is not measurable may be eligible for enrollment after consultation with the drug manufacturer and study Medical Monitor, and written documentation of this approval.
Female subjects who are pregnant or breastfeeding
Intervention: Birinapant
Trial phase: Phase 1 | Phase 2
SMILES: CC[C@H](NC(=O)[C@H](C)NC)C(=O)N1C[C@@H](O)C[C@H]1Cc1c(-c2[nH]c3cc(F)ccc3c2C[C@@H]2C[C@H](O)CN2C(=O)[C@H](CC)NC(=O)[C@H](C)NC)[nH]c2cc(F)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 22mg/m2/dose IV twice per week x 4weeks of 4 week cycle

Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Eligibility criteria:
Inclusion criteria

Subjects with a diagnosis of non-M3 AML, Relapsed or refractory ALL or Intermediate Risk 2 or High Risk disease MDS as follows:

Subjects with a diagnosis of non-M3 AML which meets one of the following criteria:

Ages 60 or older: Relapsed or refractory after at least one prior therapy for AML
Ages 60 or older: Newly diagnosed in a patient with a preceding history of myelodysplastic syndrome which has been treated with azacitidine or decitabine and who are not appropriate candidates for aggressive therapy including induction followed by allogeneic stem cell transplantation
Ages 18-59: Relapsed or refractory disease after failing three prior lines of therapy
Subjects with a diagnosis of relapsed or refractory ALL: must have failed three prior lines of therapy and be 18 years of age or older.

Subjects with a diagnosis of Intermediate Risk 2 or High Risk disease (as defined by IPSS score):

Must have failed to respond/intolerant to, or progressed after a hypomethylating agent, and must not be candidates for allogeneic stem cell transplantation
Life expectancy of at least 4 weeks
Must have recovered from toxic effects of prior chemotherapy
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.

Exclusion criteria

Cytotoxic chemotherapy (including azacitidine or decitabine) within the past 28 days other than hydroxyurea
Active participation in any other investigational treatment study for AML.
ECOG performance status greater than 2
Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
QT interval corrected for heart rate (QTcB) greater than 480 msec (including subjects on medication). Subjects with a ventricular pacemaker for whom QT interval is not measurable may be eligible for enrollment after consultation with the drug manufacturer and study Medical Monitor, and written documentation of this approval.
Female subjects who are pregnant or breastfeeding
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 | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: FX006: Single 3 mL IA injection
Eligibility criteria:
Main 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 >=40 years of age
Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
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

Main Exclusion Criteria

Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History of infection in the index joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament)
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
Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
Prior arthroscopic or open surgery of the index knee within 12 months of Screening
Planned/anticipated surgery of the index knee during the study period
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Insulin-dependent diabetes
Active psychiatric disorder including psychosis and major depressive disorder
History of or active Cushing's syndrome
Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
Skin breakdown at the knee where the injection would take place
Women of child-bearing potential not using effective contraception or who are pregnant or nursing