anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Participants were randomly assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg),

Midazolam: A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Eligibility criteria:
Inclusion:

MDD Cohort:

Meet DSM-5 criteria for Major Depressive Disorder by structured interview (MINI-KID)
CDRS-R score >40.
Failure to achieve remission with at least 1 adequate prior antidepressant trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.

Anxiety Cohort:

Meet DSM-5 criteria for any of the following anxiety disorders: Social Anxiety Disorders, Generalized Anxiety Disorder, Separation Anxiety Disorder and/or Panic Disorder by structured interview (MINI-KID)
ADIS Clinical Severity Rating ≥4 (moderately severe) for any of the 4 included anxiety disorders
Failure to achieve remission with at least 1 adequate prior anxiolytic medication trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.
Failure to achieve remission with previous CBT or subject declines current CBT therapy

Both cohorts:

Stable psychiatric medications and doses for the month prior to enrollment. Subjects may continue to engage in any ongoing psychotherapy.
Medically and neurologically healthy on the basis of physical examination and medical history.
Parents able to provide written informed consent and adolescents must additionally provide assent.

Exclusion:

Current inpatient hospitalization or active suicidal ideation requiring referral for inpatient hospitalization for safety.
History of psychotic disorder or manic episode diagnosed by MINI-KID
History of substance dependence diagnosis by MINI-KID (excluding tobacco) or positive urine toxicology.
Pregnancy (urine pregnancy tests on the day of scans for menstruating girls).
Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Eligibility criteria:
Inclusion Criteria:

age 18 years old or older;
onset of septic shock within 6 h

Exclusion Criteria:

Systemic corticosteroid therapy within the last 3 months before septic shock;
high-dose steroid therapy;
immunosuppression;
refusal of the attending staff or patient family.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Equivalent volume of saline given once

Normal saline
Eligibility criteria:
Inclusion Criteria:

Brain-dead organ donor being managed by OPO (organ procurement organization)
Lungs being considered for recovery and transplant
Baseline ABG (after authorization) with P/F ratio < 300

Exclusion Criteria:

No authorization for research
Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease [COPD], human immunodeficiency virus [HIV] infection)
Intervention: Lincomycin
Trial phase: Phase 3
ATC code: J01FF02
SMILES: [H][C@@]1(C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@@H](C)O)C[C@@H](CCC)CN1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Participants formed the Safety Set (SS).
Eligibility criteria:
Inclusion Criteria:

An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been treated with lacosamide monotherapy

Exclusion Criteria:

Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
Subject meets a "must" withdrawal criteria for SP0994
Subject is experiencing an ongoing Serious Adverse Event from SP0994
Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study
Intervention: Ibuprofen
Trial phase: Phase 4
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
Healthy volunteers: No
Participants at risk: 24
Group description: Ibuprofen, 10 mg/kg

Ibuprofen: Ibuprofen, 10 mg/kg
Eligibility criteria:
Inclusion Criteria:

Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
Have a clinical indication of pain or fever.
Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.

Exclusion Criteria:

Have inadequate intravenous access.
Have an uncorrected ductus dependent congenital heart disease.
Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
Have a current history of uncorrected hypovolemia or acute renal disease.
Have a current history of acute liver disease.
Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.

Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.
Eligibility criteria:
Inclusion Criteria:

24 males will be included in the study recruited from Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular ED proved by penile duplex.
Unable to develop erections sufficient for intercourse.
Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
Age between 40 to 70 years.

Exclusion Criteria:

Significant cardiovascular disease interfering with sexual activity
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Eligibility criteria:
Inclusion Criteria:

Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital.

Exclusion Criteria:

Non-English speaking.
Patient refusal to participate.
Weight exceeding 100kg.
Baseline hemoglobin of less than 10.
Repeat, revision, or bilateral surgery.
Known sensitivity or allergy to Tranexamic Acid.
Active intra-vascular clotting.
History of coagulopathy or congenital thrombophilia.
Thromboembolic event in the 12 months prior to enrollment.
Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment.
History of anticoagulant medication use unless stopped prior to surgery as recommended by and in accordance with the American Society of Regional Anesthesia Guidelines.
Use of a general anesthetic in the current anesthetic.
Blood transfusion for a hemoglobin value which deviates from the study's transfusion protocol.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Eligibility criteria:
Inclusion Criteria:

Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital.

Exclusion Criteria:

Non-English speaking.
Patient refusal to participate.
Weight exceeding 100kg.
Baseline hemoglobin of less than 10.
Repeat, revision, or bilateral surgery.
Known sensitivity or allergy to Tranexamic Acid.
Active intra-vascular clotting.
History of coagulopathy or congenital thrombophilia.
Thromboembolic event in the 12 months prior to enrollment.
Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment.
History of anticoagulant medication use unless stopped prior to surgery as recommended by and in accordance with the American Society of Regional Anesthesia Guidelines.
Use of a general anesthetic in the current anesthetic.
Blood transfusion for a hemoglobin value which deviates from the study's transfusion protocol.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Eligibility criteria:
Inclusion Criteria:

Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital.

Exclusion Criteria:

Non-English speaking.
Patient refusal to participate.
Weight exceeding 100kg.
Baseline hemoglobin of less than 10.
Repeat, revision, or bilateral surgery.
Known sensitivity or allergy to Tranexamic Acid.
Active intra-vascular clotting.
History of coagulopathy or congenital thrombophilia.
Thromboembolic event in the 12 months prior to enrollment.
Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment.
History of anticoagulant medication use unless stopped prior to surgery as recommended by and in accordance with the American Society of Regional Anesthesia Guidelines.
Use of a general anesthetic in the current anesthetic.
Blood transfusion for a hemoglobin value which deviates from the study's transfusion protocol.
Intervention: Ethanol
Trial phase: Not Applicable
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Alcohol -based spray as placebo will be administrated before arterial puncture.

Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
Eligibility criteria:
Inclusion Criteria:

age: 18-85 years old.
arterial gasometry determination needed
III, IV or V level classification on Manchester triage.

Exclusion criteria:

refusal to participate,
inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
skin disease associated with cold intolerance (Raynaud's phenomenon),
known allergy to spray contents,
Glasgow Coma Scale <15,
pregnancy,
under effects of alcohol or drugs,
Allen test +.
Intervention: Chloroethane
Trial phase: Not Applicable
ATC code: N01BX01
SMILES: CCCl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Ethyl choride will be administrated before arterial puncture.

Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
Eligibility criteria:
Inclusion Criteria:

age: 18-85 years old.
arterial gasometry determination needed
III, IV or V level classification on Manchester triage.

Exclusion criteria:

refusal to participate,
inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
skin disease associated with cold intolerance (Raynaud's phenomenon),
known allergy to spray contents,
Glasgow Coma Scale <15,
pregnancy,
under effects of alcohol or drugs,
Allen test +.
Intervention: LEVOMENTHOL
Trial phase: Phase 3
SMILES: CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)

Ingredients:

16mL of peppermint oil (provided by the NowFoods® company)
0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
1L prepackage sterile water
2.6mL of undyed simethicone

Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
Eligibility criteria:
Inclusion Criteria:

At least 50 years of age in Caucasians or 45 years of age in African-Americans.
Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.
Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.

Exclusion Criteria:

History of colectomy, partial or complete
Symptoms suggesting possible colorectal stenosis or cancer
Inflammatory bowel disease
Familial polyposis syndromes
History of, or current diagnosis of colorectal cancer
American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater
Non-correctable coagulopathy
Currently receiving anti-thrombotic therapy, with an INR > 1.5
Poor prep, total BBPS score < 6, or any part of the colon < 2.
Patients with known allergy to peppermint oil or peppermint containing products.
Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).
Intervention: CID 12303048
Trial phase: Phase 2
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.

Chlorhexidine gluconate: Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.
Eligibility criteria:
Inclusion Criteria:

History of skin or soft tissue infection that occurred between 1 month and 5 years ago, regardless of whether antibiotics were given, as per patient report
Age > 5 years and < 18 years.
Able to gargle as assessed by verbal question.
Willing and able to undergo nares and oropharyngeal swabbing.
Able to come to the research clinic for study follow-up visits for the study period.

Exclusion Criteria:

Current suspected or confirmed infection requiring systemic antibiotics.
Receipt of systemic antibiotics in the prior 28 days.
Plans for administration or likely receipt of systemic antibiotics in the next 28 days (e.g., if the patient suffers from recurrent infections such as otitis media or has a planned surgery that requires prophylactic antibiotics).
Plans for hospitalization or likely hospitalization in the next 28 days (e.g., if the patient suffers from recurrent infections)
Any of the following in the prior 6 months: hemodialysis, peritoneal dialysis, central venous catheter placement, and systemic chemotherapy for cancer, any immune-compromising condition.
Previous participation in the study.
Pregnancy (all female subjects of childbearing age will be given a pregnancy test prior to enrollment).
Intervention: Idelalisib
Trial phase: Phase 2
ATC code: L01EM01
SMILES: [H][C@@](CC)(Nc1ncnc2[nH]cnc12)c1nc2cccc(F)c2c(=O)n1-c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.

Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression.
Eligibility criteria:
Inclusion Criteria:

3.1.1 IgM paraprotein identified on serum immunofixation electrophoresis OR light chain-restricted CD20+ lymphoplasmacytic population on biopsy of bone marrow or lymph node (identified by H&E/immunohistochemistry or flow cytometry) OR positive myeloid differentiation primary response gene 88 (MYD88-L265P) OR CXCR4WHIM mutation (CXCR4 mutation - warts, hypogammaglobulinemia, infections, myelokathexis) on submitted samples

3.1.2 Biopsy-proven relapsed or refractory AL amyloidosis

3.1.3 Age ≥ 18 years

3.1.4 Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A.)

3.1.5 Difference between serum free light chains (FLC) of >30 mg/L or quantifiable IgM paraprotein >0.5 g/L

3.1.6 Participants must have normal organ and marrow function as defined below:

Absolute neutrophil count > 1,000/mm3
Platelets > 50,000/mm3

3.1.7 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

3.2.1 Previous treatment with idelalisib

3.2.2 Glomerular filtration rate (GFR) <15 ml/min

3.2.3 Cardiac biomarker Stage III disease as determined by B-type natriuretic peptide (BNP) >100 pg/mL and Troponin-I >0.1 ng/mL (Girnius 2014)

3.2.4 alanine-aminotransferase (ALT)/aspartate aminotransferase (AST) values >2.5x upper limit of normal, Bilirubin >1.5 upper limit of normal (ULN)

3.2.5 Central nervous system (CNS) malignancy or other active malignancy

3.2.6 Lactating or pregnant women

3.2.7 Exposure to another investigational drug within 4 weeks prior to start of study treatment

3.2.8 Ongoing alcohol or drug addiction as determined by investigator

3.2.9 Amyloid-directed therapy within the past 28 days

3.2.10 History of Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) (assessed by positive Hepatitis B polymerase chain reaction assay (PCR) or Hepatitis B Surface Antigen), and/or Hepatitis C Virus (HCV) infection

3.2.11 t(11,14) translocation identified on bone marrow cytogenetics or by Fluorescence in situ hybridization (FISH)

3.2.12 Known lytic bone lesions

3.2.13 Positive cytomegaly virus (CMV) Polymerase chain reaction (PCR)

3.2.14 Previously untreated AL amyloidosis (Newly diagnosed)

3.2.15 Unwilling or unable to comply with the protocol
Intervention: Melatonin
Trial phase: Phase 4
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: non-smoker oral melatonin

non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Healthy smokers：must above 10 cigarettes per day, at least 1 year
Healthy non-smokers

Exclusion Criteria:

Cardiovascular disease
Systolic blood pressure above 140 mm Hg
Diastolic blood pressure above 90 mmHg
Psychiatric disorders
Cancer
Pregnant
Lactating
Taking antipsychotic drugs orally during the 2 weeks of the trial
Intervention: Melatonin
Trial phase: Phase 4
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: smoker oral melatonin

smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Healthy smokers：must above 10 cigarettes per day, at least 1 year
Healthy non-smokers

Exclusion Criteria:

Cardiovascular disease
Systolic blood pressure above 140 mm Hg
Diastolic blood pressure above 90 mmHg
Psychiatric disorders
Cancer
Pregnant
Lactating
Taking antipsychotic drugs orally during the 2 weeks of the trial
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects will receive dapagliflozin 10mg

Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
Eligibility criteria:
Inclusion Criteria:

T2DM subjects
18 - 70 yrs old
BMI = 25-45 kg/m2
Must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
HbA1c <10.0%
Stable body weight (± 3 lbs) over preceding 3 months
Do not participate in excessively heavy exercise

Exclusion Criteria:

Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg