anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received SAD of 400 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received SAD of 600 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received SAD of 1000 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Participants in SAD received an oral dose of 2100 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received single oral dose of 150 mg M5717 (eight days after the administration of intravenous malaria inoculum) on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants received single oral dose of 400 mg M5717 (eight days after the administration of intravenous malaria inoculum) on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: CARTEOLOL
Trial phase: Phase 2
ATC code: C07AA15 | S01ED05 | S01ED55
SMILES: CC(C)(C)NCC(O)COc1cccc2c1CCC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Standard treatment with cART according to current HIV Therapy Mexican guidelines.

Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended

20 control patients included

1 eliminated

19 patients included finally
Eligibility criteria:
Inclusion Criteria:

Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who accept to participate and who sign the letter of informed consent.
The following are the KS severity criteria: pulmonary compromise, and/or digestive tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise with generalized lymphedema.

Exclusion Criteria:

Patients with another synchronic malignant neoplasm
Patients receiving corticosteroids
Patients with active hepatitis B and/or hepatitis C
Patients with KS limited to skin with less than 30 lesions.
Patients with APACHE II score ≥15 points.
Intervention: Perflutren
Trial phase: Early Phase 1
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.

Perflutren Lipid Microspheres: Given IV

Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging
Eligibility criteria:
Inclusion Criteria:

Be diagnosed with an adnexal mass
Be scheduled for surgery to remove the adnexal mass
Be clinically stable
If a female of child-bearing potential, must have a negative pregnancy test
Be conscious and able to comply with study procedures
Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study

Exclusion Criteria:

Females who are pregnant or nursing
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) afterwards
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment

Patients who are clinically unstable, patients who are seriously or terminally ill with a life expectancy of less than 1 month, and patients whose clinical course are unpredictable; for example:

Patients on life support or in a critical care unit
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
Patients with recent cerebral hemorrhage
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock
Patients with congenital heart defects
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with respiratory distress syndrome
Patients with thrombosis within the splenic vein
Intervention: Hydrocortisone
Trial phase: Early Phase 1
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition

Hydrocortisone

[C-11]NOP-1A
Eligibility criteria:
Inclusion Criteria:

Males or females between 18 and 40 years old

Exclusion Criteria:

Current DSM-5 psychiatric disorders
Binge drinking as defined in NIAAA criteria in the past month
Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use
Currently on any prescription medical or psychotropic medication;
Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses
Currently pregnant or breast-feeding;
History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months
Metallic objects in the body that are contraindicated for MRI;
First-degree relative with psychosis or mood disorders
Intervention: Fluoromisonidazole F-18
Trial phase: Phase 2
SMILES: O=[N+]([O-])c1nccn1CC(O)CF
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: FMISO imaging at baseline, post-TACE and post-SBRT

FMISO: FMISO PET/CT imaging at baseline

FMISO: FMISO PET/CT post TACE

FMISO: FMISO PET/CT post SBRT
Eligibility criteria:
Inclusion Criteria:

Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
The appropriate criteria for inclusion for this patient population are:
Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)
Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
Willingness to undergo PET/CT
Able to lie on the imaging table for up to 1 hour.
Able to provide signed informed consent.
Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure

Exclusion Criteria:

Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy
Unable to lie on the imaging table
Age less than 18 years.
Pregnancy or lactation
Inability or unwillingness to provide informed consent.
Weight >500 lbs (the weight limit of the tomograph gantry table)
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Usual care group

Saline Loading Dose (Low Dose, Slow Infusion) =

• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...

Fentanyl Loading Dose (UC, injection) =

• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.

Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.

FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.

Fentanyl: Information included in arm descriptions
Eligibility criteria:
Inclusion Criteria:

Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
English speaking
pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
estimated length of stay greater than or equal to 5 days

Exclusion Criteria:

requiring endotracheal intubation and sedation,
severe hearing impairment,
cognitive impairment status - Mini-Mental State Examination (MMSE) </=20,
diminished capacity unable to provide informed consent;
Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Metformin started at 500 mg po twice daily (BID), and then titrated up to 1000 mg po q morning (AM) and 500 po q evening (PM) over the course of 1 month, as tolerated.

Metformin: Total daily dose titrated up to 1500 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Adults with prediabetes (defined as an A1c of 5.7-6.4%)
BMI between 27 and 40 kg/m2 (inclusive).

Exclusion Criteria:

Prior treatment with metformin or other diabetes medications,
Pregnancy,
Significant renal dysfunction (Serum Creatinine > 1.3 mg/dl for women, > 1.4 mg/dl for men),
Severe hepatic dysfunction (aspartate amnotransferease [AST] or alanine aminotransferase [ALT] > 3 times the upper limit of normal),
Ongoing alcohol or substance abuse,
Inflammatory bowel disease,
Ongoing glucocorticoid therapy,
Or inability to render informed consent.
Intervention: Zerbaxa
Trial phase: Phase 1 | Phase 2
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)[O-])N2C(=O)C(NC(=O)C(=NOC(C)(C)C(=O)O)c3nsc(N)n3)C2SC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.

Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Eligibility criteria:
Inclusion Criteria:

Patients with any infection requiring treatment with ceftolozane/tazobactam and who have met the following criteria:

Age >18 years
The presence of an indwelling external ventricular drain (EVD) or requiring EVD insertion due to obstructive hydrocephalus/subarachnoid haemorrhage

Exclusion Criteria:

Known or suspected allergy to penicillins and cephalosporins
Pregnancy
Receiving renal replacement therapy
Glomerular filtration rate less than 10 mL/min
Receiving piperacillin/tazobactam or having received piperacillin/tazobactam in the past 7 days before enrolment
Intervention: Tretinoin
Trial phase: Phase 2
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks

13-cis retinoic acid: Accutane is used for the treatment of severe acne
Eligibility criteria:
Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated by at least one week, and no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse.

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Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin injections); use of anabolic steroids,illicit drugs, or consumption of more than 4 alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A- of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication containing tetracycline; personal history of serious psychiatric disorders, score of greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or other abnormal serum chemistry values; history of inflammatory bowel disease or bone disease; not living within catchment area; participation in another clinical trial

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