anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hematoporphyrin
Trial phase: Phase 3
SMILES: CC1=C(CCC(=O)O)c2cc3nc(cc4[nH]c(cc5[nH]c(cc1n2)c(C)c5C(C)O)c(C)c4C(C)O)C(C)=C3CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Group that receives actual liposomal bupivacaine injections

Exparel
Eligibility criteria:
Inclusion Criteria:

Isolated distal radius fracture

Exclusion Criteria:

No Access to a telephone
Intervention: Glucagon
Trial phase: Phase 4
ATC code: H04AA01
SMILES: CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.

Glucagon: injection of 50 micrograms of glucagon
Eligibility criteria:
Inclusion Criteria:

Age 21 to 80 years old with type 1 diabetes for at least one year.
Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), or insulin glulisine (Apidra) for at least one week prior to enrollment.
Alcohol exposure on at least one occasion in the last year consisting of at least 4 drinks in one sitting.

Exclusion Criteria:

Unable to provide informed consent.
Unable to comply with study procedures.
Unable to refrain from the consumption of alcohol at least 24 hours prior to study start.
Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
Aldehyde dehydrogenase deficiency as determined by a screening questionnaire
End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
History of pheochromocytoma (because glucagon has been reported to precipitate hypertensive crisis in the setting of pheochromocytoma). Fractionated metanephrines will be tested in patients with a history increasing the risk for a catecholamine secreting tumor:
Paroxysms of tachycardia, pallor, or headache. Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease, Episodic or treatment of refractory (requiring 4 or more medications to achieve normotension) hypertension.
History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
Inadequate venous access as determined by study nurse or physician at time of screening.
Liver failure or cirrhosis
Hemoglobin < 12 gm/dl.
History of problem drinking or alcoholism, regardless of whether active or in remission.
Use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness
Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
Intervention: Lidocaine
Trial phase: Not Applicable
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: 18
Group description: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.

Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by preventing pain signals before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered.
Eligibility criteria:
Inclusion Criteria:

All women aged greater than 18 years of age scheduled to undergo cystoscopy with hydrodistention
who are literate,
English speaking and
can provide written informed consent will be included in this study.

Exclusion Criteria:

Patients who have intolerance or known allergies to local analgesia will be excluded.
In addition, patients who have coagulation disorders will also be excluded as this may increase their risks of complication from bleeding.
Patient will also be excluded if they have a history of dementia as this may impair their ability to follow instructions.
Patients who are non-ambulatory and who have an inability to fully assess pain will also be excluded.
Patients receiving additional surgical procedures will be excluded from the study, as the source of their pain may be difficult to decipher in the immediate post-operative period.
Intervention: Revefenacin
Trial phase: Phase 3
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 364
Group description: 88 mcg

TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Intervention: Revefenacin
Trial phase: Phase 3
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 335
Group description: 175 mcg

TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 356
Group description: 18 mcg

Tiotropium: Active comparator
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Intervention: Goserelin
Trial phase: Phase 3
ATC code: L02AE03
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.

GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Premenopausal women 18 to 49 years of age are eligible for enrollment
Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
Human chorionic gonadotropin negative by urine test before entering the group.
Informed consent, understanding and compliance with the requirements of the study.
No significant chronic disease and any organ dysfunction.

Exclusion Criteria:

Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Two patients did not complete the TRACTOR Trial protocol due to adverse medication side effects, and five other patients had mild systemic symptoms which were potentially related to ticagrelor. Five additional patients reported unusual bruising while on ticagrelor but had no other clinical issues and completed the trial protocol. There were no significant bleeding issues in any patient treated with ticagrelor. All adverse medication effects were evaluated by the TRACTOR Trial DSMB. None were deemed to be a serious adverse event.
Eligibility criteria:
Inclusion Criteria:

At least one year history of Episodic or Chronic migraine headache symptoms
At least 6 headache days per month
Subject able to complete online daily headache log

Exclusion Criteria:

Inability to understand the study or history of non-compliance with medical advice
Currently taking a P2Y12 inhibitor
Known hypersensitivity to Brilinta/ticagrelor
History of stroke/transient ischemic attack (TIA) in the previous 6 months
Active bleeding from any site
Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6) months
Migraine onset after 50 years of age
Renal impairment: Creatinine Clearance < 60 cc/min
Severe hepatic impairment with total bilirubin > 3.0 mg/dL
Thrombocytopenia with platelet count < 100,000 / ul
History of intracranial hemorrhage
Contraindications to blood thinner therapy or history of major bleeding episode while taking blood thinner therapy
Need for chronic oral anti-coagulation therapy (i.e. Atrial Fibrillation)
Need for chronic anti-platelet therapy (i.e. drug-eluting (DE) Stent), including daily aspirin use
Need for daily nonsteroidal anti-inflammatory drug (NSAID) use
Need for daily carbamazepine therapy or other strong CYP3A inhibitors or potent CYP3A inducers
Need for simvastatin or lovastatin greater than 40 mg daily
Symptomatic bradycardia or syncope
Pregnancy or currently breast-feeding, or plan to become pregnant during the study period
Planned surgery during the study time-frame
Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD), pacemaker, inferior vena cava filter, or left atrial appendage closure device
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.

Naproxen: Naproxen 440mg 1x bid
Eligibility criteria:
Inclusion Criteria:

• Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all ages request TCu380A. While we recognize that some women approaching menopause (median age = 51.4 years) may have changes in their baseline menstruation, we trust that clinicians enrolling the patients into the study will ensure that these women meet all inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis of menorrhagia).

Requesting to have TCu380A IUD inserted as contraceptive method.
English-speaking.
Regular menstrual cycles ranging 21-35 days apart.
Generally healthy.
Willing to attend a 4- to 6-week follow-up visit and complete surveys.

Exclusion Criteria:

Known or suspected pregnancy.

Contraindications to NSAID use. This includes underlying heart failure, chronic renal disease, chronic liver disease, peptic ulcer disease, or history of upper gastrointestinal bleed, and allergy to NSAIDs.
Current regular use of a NSAID.
Unwilling to avoid use of NSAIDs (except for study medication) for the duration of the study.
Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyps.
Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing intrauterine device (LNG IUD) within the previous 3 months.
Postpartum in the past 4 weeks. The average day in which non-breastfeeding postpartum women ovulate is 25 days after birth, indicating that menstrual cycles can resume after the 4th postpartum week.
Existing medical condition for which placement of TCu380A IUD is a contraindication according to the Centers for Disease Control and Prevention Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).
Currently breastfeeding.
Previous use of the TCu380A.
Intervention: SILVER NITRATE
Trial phase: Phase 3
ATC code: D08AL01
SMILES: O=[N+]([O-])[O-].[Ag+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.

Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Any patient falling within age group with granulation tissue around G tube site

Exclusion Criteria:

Patients falling outside of age group range
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: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.

Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
Eligibility criteria:
Inclusion Criteria:

Any patient falling within age group with granulation tissue around G tube site

Exclusion Criteria:

Patients falling outside of age group range
Intervention: Oliceridine
Trial phase: Phase 2
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Drug: TRV130
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years, inclusive
Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
Able to understand and comply with study procedures and requirements, and provide written informed consent

Exclusion Criteria:

Significant concomitant head, chest, or abdominal trauma
Multiple extremity trauma
Open fracture
Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration

Sertraline: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
Eligibility criteria:
Inclusion Criteria:

Victim of a traumatic event leading to personal injury
Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.

Exclusion Criteria:

Age < 18
Pregnant women, lactating women, or women not using acceptable form of birth control
Epilepsy or head trauma resulting in seizures
Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
Current/previously diagnosed PTSD
History of hypersensitivity to sertraline
Trauma occurring > 7 days prior to likely first treatment in the randomization phase of the trial.
Unable to provide informed consent for participation in the study protocol.
Patient at high risk of recurrent bleeding despite surgical stabilization
Patient with a history of serotonin syndrome
Patient non-fluent in English
Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)
Intervention: Hydroxyurea
Trial phase: Phase 4
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years.
Male or female.
Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (DNA) analysis.
Affiliation to a social security system.
Having freely consented in writing after being informed of the objective, programme and potential risks incurred.

These criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion during the last 6 months before inclusion:

Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men.
Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2.

Glomerular renal hyperfiltration: GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.

Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes.

Exclusion Criteria:

Refusal to consent.
Patients that do not comply.
Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.
Patients having had an exchange transfusion in the 15 days before inclusion in the study.
Patients participating in another clinical trial or in the exclusion period of a previous clinical trial.
Patients treated with a diuretic.
Dialysis patient.
Patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month.
Pregnant or breast-feeding women.
Patients deprived of liberty or under legal protection.
Patients who cannot understand the objective and the course of the study, incapable of giving their consent.
In the event of severe hepatic failure.
In the event of severe renal failure (creatinine clearance < 30 ml/min).
Patients who show toxic signs of bone marrow suppression.