anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: GED-0507-34-Levo
Trial phase: Phase 2
SMILES: CO[C@@H](Cc1ccc(N)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: GED-0507-34-Levo 160 mg BID
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 and over at the time of signing the informed consent.
Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

Exclusion Criteria:

Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
Clinical signs suggestive of fulminant colitis or toxic megacolon.
Evidence of pathogenic enteric infection.
History of colorectal cancer or colorectal dysplasia.
Prior use of any TNF inhibitor (or any biologic agent).
Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
Use of budesonide-MMx within the last 8 weeks.
Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.
Intervention: D-JNKI-1
Trial phase: Phase 3
SMILES: CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H]1CCCN1C(=O)[C@@H](CCC(N)=O)NC(=O)[C@H](NC(=O)[C@H]1CCCN1C(=O)[C@@H](CCCNC(=N)N)NC(=O)[C@@H](CO)NC(=O)[C@@H](CCC(N)=O)NC(=O)[C@H](N)CC(=O)O)C(C)C)C(=O)N[C@H](CC(N)=O)C(=O)N[C@H](CC(C)C)C(=O)N[C@@H](C(=O)N[C@@H](C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCCN)C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N1CCC[C@@H]1C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCC(N)=O)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCNC(=N)N)C(=O)NCC(=O)O)[C@H](C)O)[C@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
Eligibility criteria:
Inclusion Criteria:

Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
Age ≥ 18 years on the day of screening;

Exclusion Criteria:

Bilateral ISSNHL;
Acute hearing loss from noise trauma, barotrauma or head trauma;
Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
History of otosclerosis in the affected ear;
Suspected perilymph fistula or membrane rupture in the affected ear;
Congenital hearing loss;
History of ISSNHL in the past 2 years;
Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
Intervention: D-JNKI-1
Trial phase: Phase 3
SMILES: CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H]1CCCN1C(=O)[C@@H](CCC(N)=O)NC(=O)[C@H](NC(=O)[C@H]1CCCN1C(=O)[C@@H](CCCNC(=N)N)NC(=O)[C@@H](CO)NC(=O)[C@@H](CCC(N)=O)NC(=O)[C@H](N)CC(=O)O)C(C)C)C(=O)N[C@H](CC(N)=O)C(=O)N[C@H](CC(C)C)C(=O)N[C@@H](C(=O)N[C@@H](C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCCN)C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N1CCC[C@@H]1C(=O)N1CCC[C@@H]1C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCC(N)=O)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCNC(=N)N)C(=O)NCC(=O)O)[C@H](C)O)[C@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
Eligibility criteria:
Inclusion Criteria:

Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
Age ≥ 18 years on the day of screening;

Exclusion Criteria:

Bilateral ISSNHL;
Acute hearing loss from noise trauma, barotrauma or head trauma;
Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
History of otosclerosis in the affected ear;
Suspected perilymph fistula or membrane rupture in the affected ear;
Congenital hearing loss;
History of ISSNHL in the past 2 years;
Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.

Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
Eligibility criteria:
Inclusion Criteria:

Ischemic stroke and measurable deficit on the initial NIHSS (> 1)
Cognitive impairment within the 5th and 50th percentiles for age, race, and education based on Montreal Cognitive Assessment (MoCA) or 2 out of 5 delayed recall or less on the MoCA.
Able to sign informed consent, have a caregiver, and live within a reasonable driving distance from Wake Forest Baptist Medical Center.

Exclusion Criteria:

Patients under age 40 or 90 years or older
Living in skilled nursing facility
Severe stroke deficits at 4 weeks that prohibit participation in cognitive testing (global or receptive aphasia, or severe expressive aphasia)
Diabetes requiring insulin
Psychiatric disorders
Severe head trauma
Alcoholism
Neurologic disorders other than stroke
Renal disease
hepatic disease
chronic obstructive pulmonary disease
unstable cardiac disease
those with prior deficits in ADLs and IADLs
Intervention: Acetic acid C-11
Trial phase: Phase 2
ATC code: G01AD02 | S02AA10
SMILES: CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients with Mild Cognitive Impairment (MCI) (up to 14) will be recruited primarily from the Penn Memory Center (PMC). Clinical diagnostic criteria (described in further detail in Study Procedures section) will be used to identify subjects who are meet criteria for amnestic MCI. Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.

11C-acetate: Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.
Eligibility criteria:
Inclusion Criteria for amnestic MCI cohort:

Participants will be at least 65 years of age
Positive brain amyloid PET/CT scan within 6 months of study screening
Mini-mental status examination (MMSE) score ≥ 24 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of 11C-Acetate PET/CT and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must identify a study partner who is willing to accompany the patient to study visits
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.

Inclusion Criteria for Control cohort:

Participants will be at least 65 years of age
History of negative brain amyloid PET/CT scan within 6 months of study screening OR negative cerebrospinal fluid (CSF) analysis for AD biomarkers within 6 months of study screening
Mini-mental status examination (MMSE) > 27 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria for both cohorts:

Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
History of stroke or other neurological disease that in the opinion of the investigator might interfere with evaluation of the 11C-Acetate scan
Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Intervention: Acetic acid C-11
Trial phase: Phase 2
ATC code: G01AD02 | S02AA10
SMILES: CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Normal control subjects in the same age range (up to 6) will be recruited from a current ongoing study investigating neuroinflammation in late life depression and healthy controls, from the control group in which all subjects receive MRI and LP and from the PMC research cohort. Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.

11C-acetate: Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.
Eligibility criteria:
Inclusion Criteria for amnestic MCI cohort:

Participants will be at least 65 years of age
Positive brain amyloid PET/CT scan within 6 months of study screening
Mini-mental status examination (MMSE) score ≥ 24 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of 11C-Acetate PET/CT and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must identify a study partner who is willing to accompany the patient to study visits
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.

Inclusion Criteria for Control cohort:

Participants will be at least 65 years of age
History of negative brain amyloid PET/CT scan within 6 months of study screening OR negative cerebrospinal fluid (CSF) analysis for AD biomarkers within 6 months of study screening
Mini-mental status examination (MMSE) > 27 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria for both cohorts:

Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
History of stroke or other neurological disease that in the opinion of the investigator might interfere with evaluation of the 11C-Acetate scan
Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Intervention: Tofacitinib
Trial phase: Phase 2
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU
Stable hair loss present for 6 months or longer
No treatment for alopecia areata in the past 1 month
No evidence of spontaneous hair regrowth

Exclusion Criteria:

Patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study
Patients whose current episode of AT or AU is more than 5 years
Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
Patients known to be HIV or hepatitis B or C positive
Patients with positive tuberculin skin test or positive QuantiFERON® TB test
Patients with leukopenia or anemia
Patients with renal or hepatic impairment
Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors
Women who are pregnant or nursing
Intervention: Efinaconazole
Trial phase: Phase 4
ATC code: D01AC19
SMILES: C=C1CCN([C@H](C)[C@](O)(Cn2cncn2)c2ccc(F)cc2F)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Efinaconazole

Efinaconazole: Solution
Eligibility criteria:
Key Inclusion Criteria:

Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male or female subjects of any race, 12 to 16 years of age (inclusive).
Verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian.
Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.
Target great toenail for all subjects, and both great toenails for subjects in the PK subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed.
Subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation).

Key Exclusion Criteria:

Females who are pregnant, nursing an infant, or planning a pregnancy during the study period.
History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection.
History of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject).
Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).
Intervention: Cannabidiol
Trial phase: Phase 1 | Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.

12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring

Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with Dravet syndrome or Lennox-Gastaut syndrome
Patients who are planning to obtain medical cannabidiol
Patients who are already taking medical cannabidiol and are planning to stop taking it

Exclusion Criteria:

Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome
Intervention: Descovy
Trial phase: Phase 4
ATC code: J05AR17
SMILES: CC(C)OC(=O)C(C)NP(=O)(COC(C)Cn1cnc2c(N)ncnc21)Oc1ccccc1.Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks

tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
Eligibility criteria:
Inclusion Criteria:

Biological female aged 40-60
Documented HIV-1 infection
Peri-menopausal ( as documented by history).
Signed Informed Consent Form and willing to comply with the protocol.
Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks.
Stable viral suppression (plasma HIV-RNA<50 copies/mL for > 24 weeks). Single viral blip <500/ml allowed if re-suppresses.
If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.

Exclusion Criteria:

HIV-2
High 10-year fracture risk at baseline ( > 20%) based on country specific FRAX
Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
Acute viral hepatitis
Chronic hepatitis C with liver transaminases >5 x ULN or expected to require treatment for hepatitis C during the trial period.
Any investigational ARV within 30 days.
Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ 3 x ULN and bilirubin ≥ 1.5 x ULN with > 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices.
Pregnant or breastfeeding
Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, creatinine phosphokinase, or lipid elevation.
Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator's opinion, interfere with assessments or completion of the trial.