anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Calcitriol
Trial phase: Not Applicable
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: All Group B patients will receive intralesional Vitamin D3

Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier
Eligibility criteria:
Inclusion Criteria:

1. Clinically diagnosed patients who have more than three warts or single wart in difficult to treat sites (periungual, palms and soles)

Exclusion Criteria:

Patients not under any systemic or topical treatment of warts for the last four weeks
Patients with a past history of an allergic response to MMR or any other vaccine or Vitamin D
Patients with current acute febrile illness or any bacterial infection
Immunosuppressed patients
Pregnant or lactating women
Patients having a past history of asthma, allergic skin disorders or convulsions
Patients with keloidal tendency
Patient refusal for consent
Treating physician's decision to give other treatment modality
Patients with hypervitaminosis D, muscle weakness, bone pain, altered sensorium
Intervention: Hydromorphone
Trial phase: Phase 3
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge

Hydromorphone: 1mg IV PRN q3h, post op, while inpatient
Eligibility criteria:
Inclusion Criteria:

Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
Uterine weight ≤325 grams

Exclusion Criteria:

contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
current opioid prescription
Intervention: Remdesivir
Trial phase: Phase 2 | Phase 3
ATC code: J05AB16
SMILES: CCC(CC)COC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@](C#N)(c2ccc3c(N)ncnn23)[C@H](O)[C@@H]1O)Oc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.
Eligibility criteria:
Key Inclusion Criteria:

Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)).

a) Cohort 1: ≥ 12 years to < 18 years of age and weight at screening ≥ 40 kg
b) Cohorts 2-4: ≥ 28 days to < 18 years of age and weight at screening ≥ 3 kg and < 40 kg
c) Cohort 5: ≥ 14 days to < 28 days of age, gestational age > 37 weeks and weight at screening ≥ 2.5 kg
d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of ≥ 2.5 kg
e) Cohort 7: 0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg
f) Cohort 8: < 12 years of age and weight at screening ≥ 40 kg
Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR).
Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19).

Key Exclusion Criteria:

Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing.
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN).
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 using Schwartz formula for individuals ≥ 1 year of age.
Creatinine above protocol specified thresholds for < 1 year of age.
Positive pregnancy test at Screening only for female of child bearing potential. Note: If female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator.
On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)).

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: SALICYLIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: D01AE12 | N02BA04 | N02BA12 | S01BC08
SMILES: O=C(O)c1ccccc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 203
Group description: Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days

miconazole 2% oil: Drug treatment of otomycosis for 14 days
Eligibility criteria:
Inclusion Criteria:

Randomized blinded initial phase of study:

Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only,
Intact tympanic membrane in the ear(s) to be treated with study drug,
In general good health as determined by medical examination and medical history,
Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.

Open-label second phase of study:

Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug,
In general good health as determined by medical examination and medical history,
Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.

Exclusion Criteria::

Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections that require antimicrobial treatment,
Disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s);
Tympanostomy tube or perforated tympanic membrane;
History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, except for prior tympanostomy tube(s) that have already been removed and completely healed;
Use of any topical medicated treatments for otomycosis within 14 days of study entry;
Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry;
Fever of ≥100°F at study entry;
Otomycosis that has been unresponsive to previous antifungal treatment;
Known hypersensitivity to any of the components in the test formulation;
Participation in another investigative trial within 28 days of study entry
Intervention: Nicotine
Trial phase: Phase 2
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Participants will wear open label transdermal nicotine patch daily for 12-15 weeks. They will apply study patch each morning and remove at bedtime. Dosage will begin at 3.5mg patch / day, increasing to a possible maximum of 21mg patch / day.

Transdermal Nicotine patch: Participants will begin a 12- week open label trial of transdermal nicotine patch during the day and remove it at night (16 hours). Dose titration starting at 3.5 mg patch/daily to maximum of 21mg patch/daily.

After week 12 , dose will be slowly tapered over 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Age > 60 years;
Diagnosis of major depressive disorder, single or recurrent episode (DSM5);
On a stable therapeutic dose of an allowed selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 8 weeks;
Severity: Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 15;
Cognition: Mini-Mental State Examination (MMSE) score ≥ 24;
Fluent in English

Exclusion Criteria:

Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) symptoms occurring in a depressive episode;
Use of other medications for depression, e.g., bupropion or augmenting agents, although short-acting sedatives are allowed (see below);
Any use of tobacco or nicotine in the last year;
Living with a smoker or regular exposure to secondhand smoke;
History of alcohol use disorder or substance use disorder of moderate or greater severity (endorsing 4 or more of the 12 criteria) in the last 12 months;
Acute suicidality;
Acute grief (<1 month);
Current or past psychosis;
Primary neurological disorder, including dementia, stroke, epilepsy, etc.;
MRI contraindication;
Electroconvulsive therapy or transcranial magnetic stimulation in last 2 months;
Current or planned psychotherapy;
Allergy or hypersensitivity to nicotine patches;
In the last 4 weeks, regular use of drugs with central cholinergic or anticholinergic properties or moderate / severe CYP2A6 inhibitors /inducers.
Intervention: ABSK-091
Trial phase: Phase 2
SMILES: COc1cc(CCc2cc(NC(=O)c3ccc(N4C[C@@H](C)N[C@@H](C)C4)cc3)n[nH]2)cc(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

FGFR Inhibitor AZD4547: Given PO
Eligibility criteria:
Inclusion Criteria:

Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
Patients must have FGFR 1-3 mutation or translocation as determined by the MATCH screening assessment
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Patients must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition scan [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible
Patients must have a pre-study eye exam by an ophthalmologist. Patients with current evidence of corneal or retinal disorder/keratopathy are excluded

Exclusion Criteria:

Patients must not have known hypersensitivity to AZD4547 or compounds of similar chemical or biologic composition
Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398, erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be allowed
Patients must not have any history of or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis, or history of or current evidence of extensive tissue calcification (by evaluation of the clinician), including but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification per investigators' judgment

Patients must not be currently using medications that can elevate serum phosphorous and/or calcium levels

Medications that increase serum calcium should be avoided. Over the counter calcium supplements, antacids that contain calcium (Tums) and vitamin D supplements (cholecalciferol and ergocalciferol) should be avoided. Prescription medications including lithium, hydrochlorothiazide and chlorthalidone must be used with caution
Medications that increase serum phosphate should be avoided. Over the counter laxatives that contain phosphate such as Fleets Oral or Fleets enema and Miralax should be avoided
Intervention: TESTOSTERONE CYPIONATE
Trial phase: Phase 4
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](OC(=O)CCC3CCCC3)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months

Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
Eligibility criteria:
Inclusion Criteria:

Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
Serum total testosterone < 300 ng/dL on 2 measurements
Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 months following androgen treatment.
Men deemed to be candidates for TRT based on the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)
Body mass index (BMI) ≥ 40 kg/m2.

Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

Baseline hemoglobin > 16 g/dL or Hematocrit (HCT) 48%
Prostate Specific Antigen (PSA) > 4 ng/mL
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
Receipt of any subcutaneous testosterone pellets within the last 6 months.
Inability to understand and provide written informed consent for the study.
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.

Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
Eligibility criteria:
Inclusion Criteria:

Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
Serum total testosterone < 300 ng/dL on 2 measurements
Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 months following androgen treatment.
Men deemed to be candidates for TRT based on the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)
Body mass index (BMI) ≥ 40 kg/m2.

Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

Baseline hemoglobin > 16 g/dL or Hematocrit (HCT) 48%
Prostate Specific Antigen (PSA) > 4 ng/mL
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
Receipt of any subcutaneous testosterone pellets within the last 6 months.
Inability to understand and provide written informed consent for the study.
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 93
Group description: This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.

Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
Eligibility criteria:
Inclusion Criteria:

Female
Primary or secondary cesarean delivery
Able to consent to research study

Exclusion Criteria:

3 or more prior cesarean deliveries
History of abdominoplasty
History of abdominal hernia repair with mesh
Allergy to lidocaine
Allergy to adhesives in medical tape
Women who received general anesthesia for their cesarean delivery
Women with active substance abuse
Women methadone or suboxone for a history of opiate abuse
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Atomoxetine oral capsule administered before sleep

Atomoxetine: Oral administration before bed
Eligibility criteria:
Inclusion Criteria:

Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
AHI 10 to <20, or AHI ≥20 if meets PSG criteria

Exclusion Criteria:

History of narcolepsy.
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
CPAP should not be used for at least 2 weeks prior to first study PSG
History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Intervention: Magnesium Sulfate
Trial phase: Phase 3
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Experimental bowel preparation solution for oral ingestion

Bowel Prep: Orally ingested liquid bowel preparation
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
18 to 85 years of age (inclusive)
If female, and of child-bearing potential, is using an acceptable form of birth control.
Negative serum pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
Subjects who had previous significant gastrointestinal surgeries.
Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
Subjects with uncontrolled hypertension.
Subjects taking antibiotics within 7 days of colonoscopy.
Subjects with severe renal, hepatic or cardiac insufficiency.
Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
Subjects undergoing insulin therapy for any indication.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Subjects taking tricyclic antidepressants.
Subjects using drugs of abuse, including abused prescription medications.
Subjects who are withdrawing from alcohol or benzodiazepines.