anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Desoximetasone
Trial phase: Phase 3
ATC code: D07AC03 | D07XC02
SMILES: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1(F)[C@@H](O)C[C@]1(C)[C@@H](C(=O)CO)[C@H](C)C[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days

Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating female 18 years of age or older.
Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion.
Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion.
The Target Lesion must have an area of at least 5 cm².
Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp.
Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy.
In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
Receipt of any drug as part of a research study within 30 days prior to first dosing.
Intervention: Iloperidone
Trial phase: Phase 4
ATC code: N05AX14
SMILES: COc1cc(C(C)=O)ccc1OCCCN1CCC(c2noc3cc(F)ccc23)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 240
Group description: Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Males or females, 18 to 64 years of age, inclusive
DSM-IV diagnosis of schizophrenia
Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects

Exclusion Criteria:

Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
Acutely psychotic or patient's symptom severity requires hospitalization
Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Iloperidone
Trial phase: Phase 4
ATC code: N05AX14
SMILES: COc1cc(C(C)=O)ccc1OCCCN1CCC(c2noc3cc(F)ccc23)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 260
Group description: Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Males or females, 18 to 64 years of age, inclusive
DSM-IV diagnosis of schizophrenia
Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects

Exclusion Criteria:

Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
Acutely psychotic or patient's symptom severity requires hospitalization
Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Hydromorphone
Trial phase: Phase 4
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Eligibility criteria:
Inclusion Criteria:

individuals with chronic pain of more than 6 months duration
pain is determined to be secondary to a documented neuropathy
patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week)
male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement
female patients of child-bearing potential must be using an acceptable form of birth control

Exclusion Criteria:

pregnant or lactating women
allergy to morphine or its derivatives
history of alcohol or substance abuse in the last 3 yrs
participation in any other clinical trial in the last 30 days
uncontrolled pain
patient who is deemed to be medically unstable by principal investigator
history of severe lung disease or asthma that is deemed medically significant by principal investigator
Intervention: PROPYLENE GLYCOL
Trial phase: Not Applicable
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Artificial tear emulsion

Systane Balance: Artificial tear emulsion drop
Eligibility criteria:
Inclusion Criteria:

Schein symptom score (all 6 questions) of greater than 5,
evidence of MGD changes in both eyes (i.e.,
lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale).

Exclusion Criteria:

contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded),
unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery,
diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of < 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs.

-Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above. -
Intervention: Picropodophyllin
Trial phase: Phase 1 | Phase 2
SMILES: COc1cc(C2c3cc4c(cc3C(O)C3COC(=O)C23)OCO4)cc(OC)c1OC
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: IGF-1 plus standard steroid treatment

IGF-1: IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months.
Eligibility criteria:
Inclusion Criteria:

DMD diagnosed with mutational testing and/or complete absence of dystrophin on muscle biopsy
Proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor and going up steps)
Male
Age > 5 years of age
Bone maturation (assess by bone age x-ray): </= 11 years of age
Daily GC (prednisone or deflazacort) therapy for > 12 months
Ambulatory
Informed consent
Willingness and ability to comply with all protocol requirements and procedures

Exclusion Criteria:

Current or prior treatment with growth hormone or IGF-1 therapy
Non-ambulatory
Pubertal (based on clinical Tanner staging examination)
Congestive cardiac failure
History of intracranial hypertension
Daytime ventilatory dependence (non-invasive or tracheostomy)
Concomitant therapy - any other medications/supplements that would be considered, in the opinion of the investigators, to affect muscle function, need to have been started 3 months prior to enrollment
Patients enrolled in other clinical drug trials
Any physical or mental conditions which may, in the investigators'opinions, render the subject unable to complete the tasks of the study appropriately
There will be no selection by ethnicity
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks

Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Eligibility criteria:
Inclusion Criteria:

healthy postmenopausal women
45 to 70 years of age
on HRT and willing to continue the same HRT regimen for the next 6 months
are in a stable relationship which was started at least 6 months ago
continue on any concomitant medications without any change during the study
give informed consent.

Exclusion Criteria:

have dyspareunia
have received testosterone implants within the last 12 months or other androgen therapy within the last 6 months
have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS)
have a significant psychiatric disorder
have a history of breast cancer
have diabetes, thromboembolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
are on tibolone (due to its androgenic effect).
Intervention: Ciprofloxacin
Trial phase: Phase 3
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 415
Group description: Ciprofloxacin 500 mg capsules

Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent,
Men or women between 18 and 85 years of age,
History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control

Exclusion Criteria:

Residency in any country with high incidence rate of TD within the past 6 months,
Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
Known or suspected infection with non-bacterial pathogen,
Presence of diarrhoea of >72 hours duration,
Presence of grossly bloody stool,
Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
History of inflammatory bowel disease or celiac disease,
Intervention: Epiduo
Trial phase: Phase 4
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2.O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, aged 16 to 25 years inclusive;
Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
Subjects who agree to be photographed at each visit;
Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion Criteria:

Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
Subjects with a wash-out period for topical acne treatment on the face less than 30 days
Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
Subjects who are currently being treated with antibiotics;
Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Gabapentin titrated to 2400 mg daily PO for 5 weeks
Eligibility criteria:
Inclusion Criteria:

Potential participants must:

Be between the ages of 21 and 55 years of age.
DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
Be compliant in methadone treatment
On a stable dose of methadone at least 6 weeks.
Have provided random urine samples absent of any non-prescribed drugs of abuse x 2 months
Be in good physical health or in the case of a medical condition needing ongoing treatment, be in the care of a physician who is willing to take responsibility for such treatment. The same conditions apply in cases of patients with a psychiatric disorder needing ongoing treatment.
Be agreeable to and capable of signing an informed consent.

Exclusion Criteria:

Potential participants must not:

Have known sensitivity to gabapentin.
Be substance dependent on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
Have any acute medical condition that would make participation medically hazardous, (e.g., acute hepatitis, unstable cardiovascular disease, liver or renal disease) or have liver enzyme values (AST or ALT) greater than 5 times normal range.
Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
Have a neurological or psychiatric illness (i.e., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses.
Be currently taking opioid analgesic medication for a painful condition on a regular basis.
Be a nursing or pregnant female. Female of childbearing potential must agree to use a medically acceptable method of birth control, (e.g. oral contraceptives, barrier (diaphragm or condom) with or without spermicide, levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection) or to complete abstinence. Females who become pregnant during the course of the study will be dropped from the study.
Have a current or past history of high blood pressure, heart disease, stroke or currently have a pacemaker.
Intervention: Zolmitriptan
Trial phase: Phase 4
ATC code: N02CC03
SMILES: CN(C)CCc1c[nH]c2ccc(C[C@H]3COC(=O)N3)cc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 92
Group description: ZOMIG nasal spray
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
Established diagnosis of migraine.
History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria:

Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.
Intervention: Zolmitriptan
Trial phase: Phase 4
ATC code: N02CC03
SMILES: CN(C)CCc1c[nH]c2ccc(C[C@H]3COC(=O)N3)cc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 81
Group description: ZOMIG nasal spray
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
Established diagnosis of migraine.
History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria:

Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.
Intervention: Ziprasidone
Trial phase: Phase 3
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 190
Group description: Ziprasidone

Ziprasidone: Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.
Eligibility criteria:
Inclusion Criteria:

adult patients (≥18 years old)
in a medical and/or surgical ICU
on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
delirious (according to the CAM-ICU)

Exclusion Criteria:

Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
Ongoing maintenance therapy with typical or atypical antipsychotics
History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.
Intervention: Methylprednisolone
Trial phase: Phase 4
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
Eligibility criteria:
Key Inclusion Criteria:

Must have been receiving natalizumab for multiple sclerosis (MS) prior to the diagnosis or suspicion of Progressive multifocal leukoencephalopathy (PML).
Subject must be willing to undergo or have completed plasma exchange (PLEX) prior to initiating study treatment.

Key Exclusion Criteria:

History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Intervention: Levemir
Trial phase: Phase 4
SMILES: CCCCCCCCCCCCCC(=O)NCCCCC(NC(=O)C1CCCN1C(=O)C(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(Cc1ccccc1)NC(=O)C(Cc1ccccc1)NC(=O)CNC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C1CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C2CSSCC(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(NC(=O)CN)C(C)CC)C(C)C)C(=O)NC(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)N1)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)N2)C(C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Insulin treatment to target blood glucose at 140 mg/dl

Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Eligibility criteria:
Inclusion Criteria:

Require Liver Transplantation
Age 18 - 80
Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
Expected survival following transplantation for > 1 year.
Glucose level over 180 mg/dL postoperatively

Exclusion Criteria:

Inability of patient or family member to give informed consent
Not expected to survive for > 1 year following liver transplantation.
Previous liver transplantation
Acute liver failure
Living related donor