anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks
Eligibility criteria:
Key Inclusion Criteria:

Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.

Positive culture for dermatophytes and positive KOH.

Nail ≤ 3 mm thick at the distal end.

At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

Subjects must be able to swallow tablets.

Women of childbearing potential and males must use acceptable birth control methods throughout the study.

Key Exclusion Criteria:

Presence of subungual hematoma or melanonychia.

Presence of dermatophytoma/nail streaks and severe onychorrhexis.

Significant dystrophy or anatomic abnormalities of the great toenail.

Presence of any other infections of the foot.

Evidence of clinically significant major organ disease.

Poorly controlled diabetes mellitus.

Onychomycosis involving more than 8 toe nails.

Recent use of systemic antifungal therapy.

Recent of any topical antifungal nail therapy.

Recent use of systemic corticosteroid therapy.

Recent use of immunosuppressive medication.

History of prolonged QT intervals.

Known human immunodeficiency virus (HIV) infection.

Known significant renal or hepatic impairment.

Known history of intolerance or hypersensitivity to azole antifungal drugs.
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria:

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system corticosteroid therapies
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
Eligibility criteria:
Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria:

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system corticosteroid therapies
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria:

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system corticosteroid therapies
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
Eligibility criteria:
Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria:

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system corticosteroid therapies
Intervention: Dexmedetomidine Hydrochloride
Trial phase: Phase 4
SMILES: Cc1cccc(C(C)c2cnc[nH]2)c1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: participant who received dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery)

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

Refuse to participate;
Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
History of brain injury or neurosurgery;
Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker;
Severe hepatic dysfunction (Child-Pugh class C);
Severe renal dysfunction (requirement of renal replacement therapy);
Other conditions that are considered unsuitable for participation.
Intervention: Rapastinel
Trial phase: Phase 2
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.

Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)
Eligibility criteria:
Inclusion Criteria for Patients with No medication Washout:

Age 18-55
Physically healthy and not currently pregnant
Primary Diagnosis of OCD
currently off all psychotropic medications and other drugs
Able to provide informed consent

Exclusion Criteria for Patients with No Medication Washout:

Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance abuse in prior year[including nicotine], lifetime substance dependence disorder [except nicotine])
Female patients who are either pregnant or nursing
Enrolled in or planning to enroll in Cognitive Behavioral Therapy.
Medical conditions that make participation unsafe (e.g., high blood pressure, head injury)
Currently on medications that make participation unsafe
History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.

Inclusion Criteria for Patients with Medication Washout:

Age 18-55
Physically healthy and not currently pregnant
Primary Diagnosis of OCD
Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission and able to handle a medication washout.
Able to provide informed consent

Exclusion Criteria for Patients with Medication Washout:

Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance abuse in prior year[including nicotine], lifetime substance dependence disorder [except nicotine])
Female patients who are either pregnant or nursing
Enrolled in or planning to enroll in Cognitive-Behavioral Therapy.
Patient judged unlikely to be able to tolerated a medication washout.
Medical conditions that make participation unsafe (e.g., high blood pressure, head injury)
Currently on medications that make participation unsafe
History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.

Patient and family received standard education on concussion management in the Emergency department.

Ibuprofen: routine administration of medication for a 72 hour period
Eligibility criteria:
Inclusion Criteria:

diagnosed with a first time concussion
english speaking
presenting to Emergency with headache 24-48 hours post concussion
normal Glascow Coma Scale
8-18 years of age

Exclusion Criteria

postive findings on CT scan
patient with cervical injury
history of multiple concussions
positive neurology
Intervention: Dimethyl sulfone
Trial phase: Phase 3
SMILES: CS(C)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen

MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
Eligibility criteria:
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

DoD beneficiaries between the ages of 18-65 years old Symptoms of Low Back Pain greater than 12 weeks duration Patients with a history of lower back surgery may be included

Exclusion:

DoD beneficiaries less than 18 years old or greater than 65 years old

Lower back pain caused by any of the following:

Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process Cauda equina syndrome Treated or untreated central nervous system impairment

Meeting the criteria for surgery, including:

progressive motor deficit sphincter impairment from neurological cause disabling sciatic pain (in the absence of backache) lasting 6 weeks or more that is attributed to a compromised nerve root and demonstrated by magnetic resonance imaging or computed tomography Oncologic disease during the previous 5 years Unexplained weight loss, fever, or chills Diagnosed upper urinary tract infection within last 28 days Patients identified during standard of care interview to have a history of intravenous drug use.

Immunocompromised host

A severe comorbidity to include:

determining overall well-being (e.g. painful disabling arthritic hip joints) Cirrhosis Ongoing dialysis Radiating symptoms to lower extremities (sciatica) History of bleeding disorders History of high blood pressure History of heart, kidney, liver or ulcer disease Allergic to analgesics or Non-steroidal anti inflammatory agents (NSAIDs) Pregnant or breastfeeding Initial pain rating of greater than 8/10 on initial intake evaluation If any of the components of the comprehensive metabolic panel are outside the Nellis clinical laboratory reference ranges, the subject will be excluded from the study

If any of these four components of the complete blood count are outside of the Nellis clinical laboratory reference ranges, the subject will be excluded from the study:

White blood cell count Hemoglobin Hematocrit Platelets

Patients taking any of the following medications are excluded from participating, unless they agree to wash out for two weeks prior to entering the study:

Muscle relaxers of any type Non-steroidal anti-inflammatory agents (NSAIDs) * Patients taking naproxen must agree to wash out for two weeks prior to entering the study, but can begin taking it again, as prescribed, after Visit 1 where a baseline pain assessment is performed.

Tramadol Gabapentin Pregabalin Glucosamine Narcotic pain medications
Intervention: Ferric citrate
Trial phase: Phase 3
ATC code: V03AE08
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[Fe+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron
Eligibility criteria:
Inclusion Criteria:

Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
Age ≥18 years
CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)
Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
Must consume a minimum of 2 meals per day
Willing and able to give written informed consent

Exclusion Criteria:

Serum phosphate <3.5 mg/dL at Screening
Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening
Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
IV iron administered within 4 weeks prior to Screening
Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening
Blood transfusion within 4 weeks prior to Screening
Receipt of any investigational drug within 4 weeks prior to Screening
Cause of anemia other than iron deficiency or chronic kidney disease
Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
History of hemochromatosis
Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
Subjects with known allergic reaction to previous oral iron therapy
Previous intolerance to oral ferric citrate
Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.
Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
Inability to cooperate with study personnel
Intervention: Dalfampridine
Trial phase: Phase 3
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

dalfampridine-ER 10mg
Eligibility criteria:
Inclusion Criteria:

Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:

obvious slowness of movement assigned primarily to the stroke
use of an assistive walking device such as a cane or walker
Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability
Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT
≥ 6 months from occurrence of most recent stroke

Exclusion Criteria:

Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.
Woman who is pregnant, breastfeeding, or planning to become pregnant
History of seizures, except simple febrile seizures
Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
Botulinum toxin use within 2 months prior to the Screening Visit
Orthopedic surgical procedures in any of the extremities within the past 6 months
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.

Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo unilateral total knee arthroplasty.
American Society of Anesthesiology (ASA) Physical Class 1-3.
BMI <40 kg/m2

Exclusion Criteria:

Revision surgery.
Bilateral total knee arthroplasty.
Unicompartmental knee arthroplasty.
Patients with a contraindication to regional anesthesia. This includes abnormal clotting, skin infection in groin or near the back, the presence of neurological disorders or anatomical abnormalities of the vertebral column.
Contraindications or known drug interactions with dexamethasone.

Use of any of the following medications within the times specified before surgery:

Long-acting opioid medication within 3 days.
Any opioid medication within 24 hours.
Body weight less than 50 kilograms (~110 pounds).
Planned administration of another investigational product or procedure during the subject's participation in this study.
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function (Ejection fraction under 35%), epilepsy, myasthenia gravis), severe renal impairment (creatinine > 1.8), comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.