anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hexose
Trial phase: Phase 2 | Phase 3
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.

D-Mannose: A total of 2 g D-mannose daily
Eligibility criteria:
Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

≥ 2 symptomatic, culture-proven UTI in 6 months OR

≥ 3 symptomatic, culture-proven UTI in 12 months

ii. Postmenopausal defined as no menses for at least 12 months or surgical menopause

b. At least one documented prior uropathogen susceptible to D-mannose

c. Using VET for a minimum of four weeks prior to study day 1

Inclusion criteria for the Observational arm of the study are the same with the exception of item 'c.' above (using VET for a minimum of four weeks) as participants will not be on vaginal estrogen therapy.

Exclusion Criteria:

For the RCT arms of the study, the exclusion criteria are as follows:

Not postmenopausal
Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
History of interstitial cystitis/painful bladder syndrome
Urothelial cancer
Non-English speaking
Enrolled in other clinical trials for UTIs
Currently using D-mannose or Methenamine for UTI prevention

Exclusion criteria for the Observational arm of the study are the same with the exception of item 'e.' above (known contraindication to VET) as participants will not be on vaginal estrogen therapy.
Intervention: Glucagon Emergency Kit
Trial phase: Phase 3
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(CCCN=C(N)N)NC(=O)C(CCCN=C(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)Cc1c[nH]cn1)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: 71
Group description: A single dose of 3 mg glucagon nasal powder was administered intranasally
Eligibility criteria:
Inclusion Criteria:

Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
Intervention: Glucagon (hydrochloride)
Trial phase: Phase 3
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.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: A single dose of 1 mg glucagon hydrochloride solution was administered IM
Eligibility criteria:
Inclusion Criteria:

Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 183
Group description: Hydroxychloroquine compound for oral use

Hydroxychloroquine: Hydroxychloroquine for oral administration, dosed by weight
Eligibility criteria:
Inclusion Criteria:

Participant in TrialNet Pathway to Prevention Study (TN01)
Age 3 years or greater at the time of randomization
Willing to provide informed consent
Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
Two or more diabetes-related autoantibodies present on two separate samples
Weight of 12 kg or greater at screening
If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
Anticipated ability to swallow study medication.

Exclusion Criteria:

Abnormal Glucose Tolerance or Diabetes
History of treatment with insulin or other diabetes therapies
Ongoing use of medications known to influence glucose tolerance
Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
Known hypersensitivity to 4-aminoquinoline compounds
G6PD deficiency
History of retinopathy
Have an active infection at time of randomization
Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Be pregnant or breastfeeding.
Intervention: Levetiracetam
Trial phase: Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Enrolled subjects will be randomized to receive Levetiracetam.

Levetiracetam: LEV 1000mg twice a day.
Eligibility criteria:
Inclusion Criteria:

Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);
Safe for surgery per treating neurosurgeon;
Due to the potential implications of the treatment on the developing central nervous system (CNS), all patients must be ≥ 18 years of age at the time of entry into the study;

Laboratory Studies:

Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
Creatinine ≤ 1.5
A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men.

Exclusion Criteria:

Pregnant or need to breast feed during the study period (Negative urine β-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED;
Patients already on AED(s);
Known history of epilepsy/seizure disorder;
Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;
Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate therapy, per the discretion of the treating investigator;
Known allergy to LCM or LEV.
Intervention: Povidone iodine
Trial phase: Phase 4
SMILES: C=CN1CCCC1=O.II
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal

Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
Male
Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal

Exclusion Criteria:

Patients planned for discharge with an indwelling catheter in place
Patients unable to report urinary symptoms accurately
Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
Clinical signs or symptoms of urinary tract infection at the time of consent
Patients currently being treated for UTI
Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
Patients unable to comply with study requirements
Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Patients randomized to the thiamine arm will receive thiamine 500mg in 100mL of normal saline intravenously every 12 hours for 5 doses. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.

Thiamine 500 mg IV: Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.
Eligibility criteria:
Inclusion Criteria:

Adult patient (age ≥ 18 years)
Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous circulation (ROSC)
Within 4.5 hours of cardiac arrest event
Lactate >/=3

Exclusion Criteria:

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Traumatic etiology of arrest
Comfort measures only or anticipated withdrawal of support within 24 hours
Protected populations (pregnant women, prisoners)
Known allergy to thiamine
Intervention: Perampanel
Trial phase: Phase 4
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.

Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
Eligibility criteria:
Inclusion Criteria:

Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
Subjects aged 18 to 75.
Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
Can be safely treated, in the opinion of the investigator, with Fycompa.
Able and agrees to follow the specified titration schedule.
Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion Criteria:

Any history of non-epileptic or psychogenic seizures.
Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
Subjects with a suicidal attempt in the 12 months prior to Visit 1
Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
Intervention: Perampanel
Trial phase: Phase 4
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.

Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
Eligibility criteria:
Inclusion Criteria:

Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
Subjects aged 18 to 75.
Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
Can be safely treated, in the opinion of the investigator, with Fycompa.
Able and agrees to follow the specified titration schedule.
Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion Criteria:

Any history of non-epileptic or psychogenic seizures.
Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
Subjects with a suicidal attempt in the 12 months prior to Visit 1
Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
Intervention: IVERMECTIN
Trial phase: Early Phase 1
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Ivermectin will be administered once at 150mcg/kg, orally.

Ivermectin: 150 mcg/kg ivermectin, by mouth.
Eligibility criteria:
Inclusion Criteria:

Weight over 110 pounds and under 185 pounds

Exclusion Criteria:

Pregnancy or nursing mothers.
Immunosuppressed individuals.
Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).
Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present
Hepatitis/HIV
Currently taking warfarin
Lactose intolerance (Lactose present in placebo)
Currently taking Steroid medications (inhaled, oral or injection)
Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)
Liver or renal dysfunction
Intervention: Dichloro[(1,2,3,4,5-eta)-pentamethylcyclopentadienyl]rhodium
Trial phase: Phase 3
SMILES: Cc1c(C)c(C)[c-](C)c1C.Cl[Rh]Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 124
Group description: ORS: ORS
Eligibility criteria:
Inclusion Criteria:

Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
Children and adolescents, both genders, age from 3 months to < 18 years of age
Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

Known allergy to Racecadotril or any of its ingredients
Subjects suffering from renal or hepatic impairment
Subjects who need treatment for diarrhea other than ORS alone
Subjects with fever > 39 degrees Celsius
Subjects with bloody and/or purulent stools
Subjects suffering from antibiotic-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
Subjects with alternating bouts of diarrhea and constipation
Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease or pancreatic exocrine insufficiency
Cystic fibrosis or coeliac disease
Subjects suffering from prolonged or uncontrolled vomiting
Subjects with rare hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency
Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study
Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
Subjects with severe dehydration required for intravenous/parenteral rehydration
Subjects who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
Subjects with combined diseases or medical situations that would prevent to be enrolled depending in the judgment of the investigator
Intake of experimental drug within 30 days prior to study start
Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply
Adolescents (≥ 60 kg) not able to swallow capsules
Pregnancy and lactation