anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: 10mg tabs of dapagliflozin

dapagliflozin: Subjects will either receive 10mg tabs of dapagliflozin or identical looking placebo - inactive medication. Subjects have an equal chance of receiving dapagliflozin or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects nor the Study Site personnel will know which treatment subjects are assigned to. The study drug must be taken daily. The subject's other medications will not be changed by the study.
Eligibility criteria:
Inclusion Criteria:

Men and women at least 18 years of age
Subjects with type-2 diabetes history >=5 years
HbA1C 7-10% with glucose control medications including insulin, metformin or sulfonylurea
Medically stable
Willing to participate and sign informed consent.

Exclusion Criteria:

Contraindication to MRI
Currently or within last three months treatment with a SGLT2 inhibitor
Currently taking glucagon-like peptide (GLP)-1 receptor antagonist
Glomerular filtration rate (GFR) <60 mL/min/1.73 m2
Unstable or rapidly progressive renal disease
Hypotension with systolic blood pressure (SBP) <100 mmHg
Hypersensitivity to dapagliflozin or any excipients
Patients with severe hepatic impairment (Child-Pugh class C)
Patients with active hepatitis B or C infection

Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator:

Myocardial infarction
Cardiac surgery or revascularization (CABG/PTCA)
Unstable angina
Heart Failure - New York Heart Association (NYHA) Class IV
Transient ischemic attack (TIA) or significant cerebrovascular disease
Unstable or previously undiagnosed arrhythmia
Established peripheral artery disease (PAD)

(18) Active bladder cancer (19) Recent episode of Diabetic ketoacidosis (DKA), frequent episodes of DKA (20) High risk of fractures, amputations and fibrosis (21) Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or randomization, OR women who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent until two weeks after the last dose of study drug, OR women who are breast-feeding.
Intervention: Nabiximols
Trial phase: Phase 2
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Strengths of cannabinoids will vary across groups

Cannabinoids: Cannabinoids with different concentrations of THC and CBD
Eligibility criteria:
Inclusion Criteria:

1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
2) Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE).
3) Able to give informed consent and comply with all study procedures.

Exclusion Criteria:

1) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.
2) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
3) Subjects taking warfarin.
4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.
Intervention: Brimonidine Tartrate
Trial phase: Phase 4
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Participants will be randomized to receive a single drop of Lumify to either the left or right eye.

Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
Eligibility criteria:
Inclusion Criteria:

Adults age 18 and above able to provide informed consent to participate
Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion Criteria:

Adults unable to consent
Prisoners
Pregnant women.
Known contradictions or sensitivities to study medication (brimonidine)
Ocular surgery within the past 3 months or refractive surgery within the past six months
Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 < 1mm)
Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
Presence of an active ocular infection
Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
Inability to sit comfortably for 15 - 30 minutes
Intervention: Deflazacort
Trial phase: Phase 3
ATC code: H02AB13
SMILES: [H][C@@]12C[C@@]3([H])OC(C)=N[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@]([H])(O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Participants received deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day.
Eligibility criteria:
Inclusion Criteria:

Genetic diagnosis of LGMD2I (confirmed mutation in the fukutin-related protein [FKRP] gene).
Ability to ascend 4 stairs greater than or equal to (≥) 2.5 seconds and be able to complete the ascent and descent both at screening and baseline.
Ability to understand the nature of the study and the consent form and to comply with study related procedures.
Must weigh between 35 to 112.5 kilograms (kg).

Exclusion Criteria:

Received ≥4 weeks of continuous, systemic corticosteroid therapy within 3 months of study screening visit.
Presence of significant cardiomyopathy as defined by echocardiogram (left ventricular ejection fraction less than (<) 30 percent [%]) at screening.
Requires fulltime ventilator support.
History of chronic systemic fungal or viral infections.
History of recent bacterial infection (including tuberculosis) per discretion of the Investigator.
Diagnosis of diabetes mellitus (controlled and/or uncontrolled) defined as glycated hemoglobin (HbA1c) ≥6.5% (based on historical or present diagnosis).
History of immunosuppression or other contraindications to glucocorticosteroid therapy.
Requires concomitant use or greater than (>) 1 week of drugs or substances that are moderate to strong cytochrome P3A4 (CYP3A4) inhibitors (for example, clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) or moderate or strong CYP3A4 inducers (that is, rifampin, efavirenz, carbamazepine, phenytoin) at baseline.
Participated in an interventional clinical trial within the last 3 months prior the baseline visit.
Unable or unwilling to comply with the contraceptive requirements of the protocol.
Female participants who are pregnant and/or breastfeeding.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, psychiatric, or allergic disease.
Intervention: Brimonidine Tartrate
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months

Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):

Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
Women who satisfy one of the following:

8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

Allergic to brimonidine or any similar products, or excipients of brimonidine
Use of contact lenses within 14 days prior to Screening visit or planned use during study
Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
Intraocular pressure <5 mmHg or >22 mmHg in either eye
Active ocular infection or history of ocular herpetic keratitis
History of neurotrophic keratitis or ocular neuropathic pain
Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
Punctal occlusion within 3 months prior to Screening visit or during study
Corneal epithelial defect larger than 1 mm2 in either eye
Have active drug/alcohol dependence or abuse history
Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged ≥ 18 years;
First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
Presence of extra-oesophageal symptoms associated with GERD;
RSI score ≥ 20;
Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
Cooperative patients, able to understand and adhere to the study procedures;
Patient able to freely give their written informed consent to study participation;
Patients that freely gave the consent to management of personal data related to the study.

Exclusion Criteria:

Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
Acute or chronic rhinosinusitis;
Chronic bronchitis;
Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
Ongoing neoplasias;
Uncontrolled diabetes;
Patients with impaired liver function;
Patients with rare hereditary problems of galactose intolerance;
Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
Patients with deficiency of Lapp lactase;
Patients with syndrome of glu-gal malabsorption;
Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
Patients already in treatment with PPIs or similar products;
Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
Abuse of drug or alcohol;
Inability of the subject to adequately express his/her disturbances;
Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;
Lactating patients.
Intervention: Augmentin
Trial phase: Phase 4
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: 8-day course of ampicillin clavulanate antibiotic

ampicillin/clavulanate: FDA-approved antibiotic
Eligibility criteria:
Inclusion Criteria:

Age: 2 to 17 years of age
Diagnosis of perforated appendicitis at laparoscopy
Development of a post-appendectomy abscess that is treated with percutaneous drainage.

Exclusion Criteria:

Patients who are allergic to ampicillin
Intervention: Augmentin
Trial phase: Phase 4
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: 4--day course of ampicillin clavulanate antibiotic

ampicillin/clavulanate: FDA-approved antibiotic
Eligibility criteria:
Inclusion Criteria:

Age: 2 to 17 years of age
Diagnosis of perforated appendicitis at laparoscopy
Development of a post-appendectomy abscess that is treated with percutaneous drainage.

Exclusion Criteria:

Patients who are allergic to ampicillin
Intervention: Tofacitinib
Trial phase: Phase 4
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.

Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Eligibility criteria:
Inclusion Criteria:

Thai volunteers age between 18 and 60 years old.
Volunteers must be patients who suffer from severe AA more than 50% of the entire scalp.
Volunteers must be patients who are able to complete the monthly treatment at least in the first 6 months.

Exclusion Criteria:

Patients who suffer from other hair diseases such as: Telogen effluvium, Trichotillomania, Tinea capitis
Patients who have other diseases that can have an impact on hair loss or temporary hair loss condition with in 6 months prior to the study such as: thyroid problems, liver disease, malnutrition, hearth disease, neurological disease, gastrointestinal disorders, sexually transmitted disease, cancer, psychiatric disease.
Patients with AA who received treatment with either steroid, Anthralin or DPCP application within 1 month before the selection or patients who had oral or injection from steroid or other medication for hair loss treatment within 3 months before the selection.
Woman with pregnancy
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.

Lidocaine Topical: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.
Eligibility criteria:
Inclusion criteria

Female
Age 18-99
Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer
Able to give informed consent and follow study procedures
No previous reactions to lidocaine applications
Performance Status of 0 or 1
Reports having engaged in vaginal intercourse at least once in the last 12 months

Exclusion criteria:

Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)
Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin
Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)
Previous reactions to lidocaine applications
Previous reactions to lidocaine for the subjects' sexual partner(s)
Intervention: Tolperisone
Trial phase: Phase 2
ATC code: M02AX06 | M03BX04
SMILES: Cc1ccc(C(=O)C(C)CN2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: TID (150 mg/day)

Tolperisone: TID
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
Pain localized below the neck and above the inferior gluteal folds.
Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
Chronic pain for the previous 3 months or longer, on more days than not.
Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
Concomitant severe pain in a region other than the back.
Spinal surgery within 1 year of study entry.
Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
Subjects who test positive for alcohol by breathalyzer test.
Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
Intervention: Tolperisone
Trial phase: Phase 2
ATC code: M02AX06 | M03BX04
SMILES: Cc1ccc(C(=O)C(C)CN2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: TID (300 mg/day)

Tolperisone: TID
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
Pain localized below the neck and above the inferior gluteal folds.
Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
Chronic pain for the previous 3 months or longer, on more days than not.
Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
Concomitant severe pain in a region other than the back.
Spinal surgery within 1 year of study entry.
Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
Subjects who test positive for alcohol by breathalyzer test.
Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
Intervention: Tolperisone
Trial phase: Phase 2
ATC code: M02AX06 | M03BX04
SMILES: Cc1ccc(C(=O)C(C)CN2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: TID (450 mg/day)

Tolperisone: TID
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
Pain localized below the neck and above the inferior gluteal folds.
Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
Chronic pain for the previous 3 months or longer, on more days than not.
Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
Concomitant severe pain in a region other than the back.
Spinal surgery within 1 year of study entry.
Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
Subjects who test positive for alcohol by breathalyzer test.
Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).