anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Iloprost
Trial phase: Phase 4
ATC code: B01AC11
SMILES: CC#CCC(C)C(O)C=CC1C(O)CC2CC(=CCCCC(=O)O)CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Each patient will receive 40 ppm inhaled nitric oxide and 2.5-5 mcg inhaled iloprost in the catheterization laboratory with assessment of hemodynamic response. Patients will also receive 2.5-5 mcg iloprost during echocardiographic assessment.

Illoprost and nitric oxide administration: Iloprost will be administered by the I-neb ultrasonic nebulizer (Respironics, Cedar Grove, New Jersey) with a disposable attachment that allows for administration to a supine patient at a concentration of 10 µg/ml with a 10 minute dose of 2.5 µg and then repeated to a cumulative dose of 5.0 µg if tolerated.
Eligibility criteria:
Inclusion Criteria:

Adult patients no younger than 18 years of age
Recently diagnosed pulmonary hypertension (defined by RV systolic pressure of ≥ 40 mmHg as measured by echocardiography), going for invasive hemodynamic assessment for pulmonary hypertension
Normal left ventricular function defined as a left ventricular ejection fraction (LVEF) greater than or equal to 50%

Exclusion Criteria:

Heart failure (LVEF < 50%, diastolic dysfunction > stage 1, history or symptoms of left heart failure) - Group II pulmonary hypertension
2+ or higher MR or AI
Inadequate echocardiographic windows
Pregnancy
Systolic blood pressure ≤ 90 mmHg
Intervention: Kenalog
Trial phase: Phase 3
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: 208
Group description: Single intra-articular injection

FX006 32 mg: Single intra-articular injection
Eligibility criteria:
Inclusion Criteria:

Written consent to participate in the study
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
Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening
Qualifying score for WOMAC A at Screening and Day 1/Baseline
Index knee pain for >15 days over the last month (as reported by the patient)
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health
Willingness to abstain from use of protocol-restricted medications during the study

Exclusion Criteria:

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index knee joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Presence of surgical hardware or other foreign body in the index knee
Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Any other IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection)
Prior administration of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Each participant will self-administer 40 IU intranasal Oxytocin

Oxytocin: 40 IU oxytocin nasal spray
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria indicate that participants must
aged 18 or over
fluent in English
endorse at least one instance of mild or moderate physical IPA with their partner in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2)
both partners must be willing to participate
one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders (e.g., marijuana) is acceptable provided alcohol is the participant's primary substance of choice.

Exclusion Criteria:

Exclusion criteria include
pregnancy or breastfeeding
current or history of psychiatric or medical condition that could interfere with neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease; synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating disorders)
Body Max Index (BMI) ≥ 39
current suicidal ideation and intent
severe physical or sexual IPA in the past six months as defined by the Conflict Tactics Scale (CTS-2)
initiation of psychotropic medication in the past 4 weeks
acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).
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: No
Participants at risk: 20
Group description: Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
Eligibility criteria:
Inclusion Criteria:

Male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent.
Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment score which includes erythema in the assessment).
Access to a computer and the internet.

Exclusion Criteria:

Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
Use of topical therapy for rosacea within 2 weeks of baseline.
Use of systemic corticosteroids within 4 weeks of baseline. Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein.
Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Subjects with severe cardiovascular disease or vascular insufficiency.
Intervention: Desoximetasone
Trial phase: Phase 4
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: 24
Group description: Participants with atopic dermatitis will receive desoximetasone and no calls.

Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
Eligibility criteria:
Inclusion Criteria:

Male or female ≥18 years of age at baseline visit.

Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or more clinical features

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

No access to a phone throughout the day

Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias our results (Such as Alzheimer's or dementia)

Patient had a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
Intervention: Desoximetasone
Trial phase: Phase 4
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: 24
Group description: Participants with psoriasis will receive desoximetasone and no calls.

Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
Eligibility criteria:
Inclusion Criteria:

Male or female ≥18 years of age at baseline visit.

Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or more clinical features

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

No access to a phone throughout the day

Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias our results (Such as Alzheimer's or dementia)

Patient had a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
Intervention: Tozadenant
Trial phase: Phase 3
SMILES: COc1ccc(N2CCOCC2)c2sc(NC(=O)N3CCC(C)(O)CC3)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: 120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.

Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
Eligibility criteria:
Inclusion Criteria:

Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
Minimum of 3 years since diagnosis.
Meet Hoehn and Yahr PD stage
Good response to levodopa
Stable regimen of anti-PD medications
Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
Patient has documented a minimum amount of Off time.
If of childbearing potential (male and female) must use an acceptable method of contraception

Exclusion Criteria:

Previous tozadenant study participation
Current or recent participation in another study.
Secondary or atypical parkinsonism
Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening)
Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
Treatment with excluded medications
Untreated or uncontrolled hyperthyroidism or hypothyroidism
Clinically significant out-of-range laboratory
MMSE out of range
Current episode of major depression (stable treatment for depression is permitted).
Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Women lactating or pregnant
Hypersensitivity to any components of tozadenant or excipients
Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
History of hepatitis or cholangitis
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1084
Group description: QAW039 450 mg
Eligibility criteria:
Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

Informed consent and assent (if applicable).
Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

Written informed consent.
A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 of ≤85% of the predicted normal value.
An ACQ score ≥1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
Inability to comply with all study requirements.
Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
Intervention: Tolnaftate
Trial phase: Phase 4
ATC code: D01AE18
SMILES: Cc1cccc(N(C)C(=S)Oc2ccc3ccccc3c2)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
Patients will be discharged home with PO Tylenol and PO toradol PRN.

Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
Eligibility criteria:
Inclusion Criteria:

The inclusion criteria are the following:
Consenting, English speaking women between ages 18 and 80 who will undergo same day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
Ability to read VAS Scores

Specific vaginal procedures include, but are not limited to:

Periurethral bulking
Perineoplasty
Complete vaginectomy
Le Forte colpocleisis
Anterior repair
Posterior repair
Enterocele repair
Anterior and posterior repair
Anterior, posterior and enterocele repair
Transvaginal mesh use
Sacrospinous ligament fixation
Uterosacral ligament suspension
Vaginal paravaginal defect repair
Midurethral Sling
Sphincteroplasty
Vaginal hysterectomy, for uterus 250 g or less
Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s)
Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele
Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele
Vaginal hysterectomy, for uterus greater than 250 g
Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s)
Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele
Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele

Exclusion Criteria:

The exclusion criteria are the following:
History of chronic pelvic pain
Abdominal surgery
Laparoscopic surgery
History of psychiatric disease
Currently taking analgesic medications
Currently taking sedatives
Liver disease
Renal disease with CrCl < 60cc/min.
History of burns from application of ice.
Women who did not consent for the study.
Intraoperative concern for increased blood loss
Unable to speak English
Unable to understand VAS Scores
Undergoing concomitant abdominal or laparoscopic procedures.
Allergy to motrin, toradol, Percocet, Tylenol
Active or history of peptic ulcer disease
History of GI bleeding or perforation
Hemorrhagic diathesis
Severe uncontrolled heart failure
Inflammatory bowel disease
Intervention: Bivalirudin
Trial phase: Phase 4
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Drug: Titrated midazolam + normal saline placebo

Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.
Eligibility criteria:
Inclusion Criteria:

Patients met inclusion criteria if they were between 18- and 80-years-old and undergoing elective cataract surgery performed by a single ophthalmologist (KW).

Exclusion Criteria:

Patients younger than 18, older than 80, those with a serum creatinine >3 mg/dl, advanced liver disease (liver enzymes twice the normal range or higher), and those with an allergy to any of the study medications were excluded from the study.
Intervention: MAGNESIUM OXIDE
Trial phase: Phase 4
ATC code: A02AA02 | A06AD02 | A12CC10
SMILES: O=[Mg]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 153
Group description: MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.

Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg
Eligibility criteria:
Inclusion Criteria:

Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:

Two or fewer defecations per week.
At least one episode per week of incontinence after acquiring toileting skills.
History of excessive stool retention.
History of painful or hard bowel movements.
Presence of a large fecal mass in the rectum.
History of large-diameter stools that may obstruct the toilet. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month.

Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:

Two or fewer defecations in the toilet per week.
At least one episode of fecal incontinence per week.
History of retentive posturing or excessive volitional stool retention.
History of painful or hard bowel movements.
Presence of a large fecal mass in the rectum.
History of large diameter stools that may obstruct the toilet. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week

Exclusion Criteria:

gastroesophageal reflux disease
inflammatory bowel disease
cardiopulmonary diseases
liver disease
renal disease
genetic diseases
endocrinal diseases
received abdominal surgeries
Intervention: Reserpine
Trial phase: Phase 2
ATC code: C02AA02 | C02AA52 | C02LA01 | C02LA51 | C02LA71
SMILES: [H][C@]12C[C@@H](OC(=O)c3cc(OC)c(OC)c(OC)c3)[C@H](OC)[C@@H](C(=O)OC)[C@@]1([H])C[C@]1([H])c3[nH]c4cc(OC)ccc4c3CCN1C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).

Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
Eligibility criteria:
Inclusion Criteria:

Between the age of ≥ 6 months or ≤ 7 years old
Undergoing a laceration repair
Treating physician has determined that patient requires intranasal midazolam to facilitate the laceration repair

Exclusion Criteria:

Weight < 5 kg
Known allergy to Lidocaine or Midazolam
Does not speak English or Spanish
Nasal injury precluding IN medication delivery
Presence of intranasal obstruction (mucous/blood) not easily cleared with suction or nose blowing
Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)
Developmental delay, autism, autism spectrum disorder
Intervention: Dextromethorphan
Trial phase: Phase 4
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

patients who were allergy to medication in the research regimen
preoperative left ventricular ejection fraction less than 30%
body mass index more than 35 kg/m2
preoperative mean arterial pressure less than 60 mmHg
preoperative heart rate less than 45/min
patients with impaired renal function (serum creatinine more than 1.5 mg/dl in female and 2 mg/dl in male)
active liver disease, and who had history of symptomatic cerebrovascular disease
psychiatric problem and other neurological diseases
patients who cannot read
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 59
Group description: 0.9% Sodium Chloride

Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
Eligibility criteria:
Inclusion Criteria:

Major surgical procedure requiring arterial access

Exclusion Criteria:

Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.