anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Histamine
Trial phase: Phase 2
ATC code: L03AX14 | V04CG03
SMILES: NCCc1c[nH]cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 253
Group description: Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are:

hypothyroidism,
stable hypertension except those subjects on beta blockers including ocular preparations,
seasonal/perennial allergic rhinitis if able to wash out of antihistamines,
stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage),
migraine if not taking excluded medications,
mild anxiety/depression if not taking excluded medications, and

mild arthritic conditions if not taking excluded medications.

Willingness and ability to sign an informed consent document;
18 - 80 years of age;
Intact skin at the forearm ;
Female participants are currently practicing effective birth control methods or abstinence.

Exclusion Criteria:

Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (EDTA);
Use of medications within a duration considered to interfere with skin testing.
Known dermographism which may interfere with skin testing.
Pregnant or lactating women.
Intervention: Calcitriol
Trial phase: Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Calcitriol 2mcg IV x 1

Calcitriol
Eligibility criteria:
Inclusion Criteria:

age ≥ 18
Severe sepsis or septic shock
Central venous catheter (for blood drawing)

Exclusion Criteria:

Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose
History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
Expected to die or leave the ICU within 48 hours
History of hypersensitivity or any allergic reaction to calcitriol
End stage renal disease
Acute Kidney Injury receiving intermittent renal replacement therapy
Enrolled in a competing study
Pregnancy
Intervention: Cholecalciferol
Trial phase: Phase 3
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
Eligibility criteria:
Inclusion Criteria:

Men and women;
18 years or older;
Scheduled for elective (non-emergent) colorectal surgery;
Cleared for anesthesia; and
Expected to stay overnight following surgery

Exclusion Criteria:

Scheduled for a purely laparoscopic procedure;
Diagnosis of a terminal illness and/or in hospice care;
Inability to sign informed consent;
Inability to comply with study protocol;
Intending to start vitamin D supplementation within 30 days of surgery;
Intending to leave the Boston area during the follow-up period;
History of renal stones or hypercalcemia;
Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma primary hyperparathyroidism)
History of hypercalcemia
History of severe anemia (Hematocrit <25%)
Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication); and
Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Intervention: Melatonin
Trial phase: Not Applicable
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Identical placebo given nightly for 12 months
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women between 55 and 75 years.
Osteopenia verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5)
Written informed consent after oral and written information

Exclusion Criteria:

Severely impaired renal function (plasma creatinine >60 eGFR ml/l).
Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the doubled compared to upper limit of reference value).
Coagulation factors PP <0.6
Hypercalcemia (p-ion calcium > 1.32 nmol/l)
Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
Diseases affecting the calcium homeostasis including untreated thyroid diseases.
Regular use of medicine affecting the calcium homeostasis; including diuretics, lithium, antiepileptica, glucosteroids.
SSRI-product with fluvoxamin.
Treatment with carbamazepin
Treatment with rifampicin
Severe malabsorption syndrome including gastric or intestinal resection.
Alcohol or drug abuse.
Smokers
Major medical or social problems that will be likely to preclude participation for one year.
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 227
Group description: Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.

Ketamine (0.5 mg/kg): Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Eligibility criteria:
Inclusion Criteria:

Patients 60 and older
Competent to provide informed consent
Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic surgery, abdominal surgery, open urological surgery, open gynecological surgery, major orthopedic surgery, major vascular surgery including endovascular procedures, major ear, nose and throat surgery).

Exclusion Criteria:

Patients with an allergy to ketamine
Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g., pheochromocytoma, aortic dissection)
Unable to provide informed consent
Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)
Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone, amisulpride, sertindole)
Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.

Ketamine (1 mg/kg): High dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Eligibility criteria:
Inclusion Criteria:

Patients 60 and older
Competent to provide informed consent
Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic surgery, abdominal surgery, open urological surgery, open gynecological surgery, major orthopedic surgery, major vascular surgery including endovascular procedures, major ear, nose and throat surgery).

Exclusion Criteria:

Patients with an allergy to ketamine
Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g., pheochromocytoma, aortic dissection)
Unable to provide informed consent
Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)
Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone, amisulpride, sertindole)
Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
Intervention: Ipratropium
Trial phase: Phase 4
ATC code: R01AX03 | R03AL01 | R03AL02 | R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.
Eligibility criteria:
Inclusion Criteria:

Athletes > 13 years of age

Exclusion Criteria:

History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea on exertion).
History of cardiac disease or taking cardioactive medications.
History of smoking.
History of glaucoma.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: All subjects will receive ketamine

Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
Eligibility criteria:
Inclusion Criteria:

18-65 years old
English speaking
No other Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) diagnosis present, besides required as below.

Inclusion criteria for depressed subjects

clinical diagnosis of a current or past depressive episode
medication free for at least 2 weeks
Score >16 on Hamilton Depression Rating Scale (HDRS) if currently depressed or <11 if not currently depressed
treatment or non-treatment seeking who understand that this study is for research purposes only

Inclusion criteria for healthy controls

no current, or history of, any DSM-IV diagnosis
no first-degree relative with history of psychotic, mood, or anxiety disorder

Inclusion criteria for PTSD subjects

current Post-Traumatic Stress Disorder, as determined by the Structured Clinical Interview for DSM-IV-Text Revision (TR) (SCID) patient research edition
Clinician Administered PTSD Scale for DSM-IV-TR (CAPS) score of 50 or higher

Inclusion criteria for trauma control subjects

-history of trauma (meeting the criterion A of PTSD but not a full diagnosis of PTSD)

Exclusion Criteria:

Current or past significant medical, neurological, or metabolic disorder or loss of consciousness for 5 minutes or more
active, significant suicidal ideation
implanted metallic devices or any Magnetic Resonance (MR) contraindications
women who are pregnant or breastfeeding
met DSM-IV criteria for alcohol/illicit substance dependence in their life-time or met alcohol/illicit substance abuse within past year
history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
blood donation within eight weeks of the start of the study
radiation exposure at work that precludes study participation
blood pressure >140/80
Intervention: Vanoxerine
Trial phase: Phase 2
SMILES: Fc1ccc(C(OCCN2CCN(CCCc3ccccc3)CC2)c2ccc(F)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: vanoxerine oral capsule, 200mg

Vanoxerine: single oral dose
Eligibility criteria:
Inclusion Criteria:

provide written informed consent,
male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria:

Systolic blood pressure <100 mmHg.
Average heart rate <50 bpm.
Average QTcF (Fridericia correction) >440 ms.
Average QRS interval >140 ms.
Paced atrial or ventricular rhythm on ECG.
Serum potassium <3.5 meq/L (may be corrected prior to randomization).
Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
received amiodarone (oral or IV) in prior 3 months.
Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
Rheumatic mitral stenosis with valve area of <1.5 cm2.
Untreated hyperthyroidism.
Acute pericarditis.
AF/AFL as a result of surgery within the last 7 days
History of failed electrical cardioversion
History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
History or family history of long QT syndrome.
History of ventricular tachycardia requiring drug or device therapy.
History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
Ejection fraction (EF) of 35% or less.
Intervention: Vanoxerine
Trial phase: Phase 2
SMILES: Fc1ccc(C(OCCN2CCN(CCCc3ccccc3)CC2)c2ccc(F)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: vanoxerine oral capsule, 300mg

Vanoxerine: single oral dose
Eligibility criteria:
Inclusion Criteria:

provide written informed consent,
male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria:

Systolic blood pressure <100 mmHg.
Average heart rate <50 bpm.
Average QTcF (Fridericia correction) >440 ms.
Average QRS interval >140 ms.
Paced atrial or ventricular rhythm on ECG.
Serum potassium <3.5 meq/L (may be corrected prior to randomization).
Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
received amiodarone (oral or IV) in prior 3 months.
Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
Rheumatic mitral stenosis with valve area of <1.5 cm2.
Untreated hyperthyroidism.
Acute pericarditis.
AF/AFL as a result of surgery within the last 7 days
History of failed electrical cardioversion
History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
History or family history of long QT syndrome.
History of ventricular tachycardia requiring drug or device therapy.
History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
Ejection fraction (EF) of 35% or less.
Intervention: Vanoxerine
Trial phase: Phase 2
SMILES: Fc1ccc(C(OCCN2CCN(CCCc3ccccc3)CC2)c2ccc(F)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: vanoxerine oral capsule, 400mg

Vanoxerine: single oral dose
Eligibility criteria:
Inclusion Criteria:

provide written informed consent,
male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria:

Systolic blood pressure <100 mmHg.
Average heart rate <50 bpm.
Average QTcF (Fridericia correction) >440 ms.
Average QRS interval >140 ms.
Paced atrial or ventricular rhythm on ECG.
Serum potassium <3.5 meq/L (may be corrected prior to randomization).
Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
received amiodarone (oral or IV) in prior 3 months.
Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
Rheumatic mitral stenosis with valve area of <1.5 cm2.
Untreated hyperthyroidism.
Acute pericarditis.
AF/AFL as a result of surgery within the last 7 days
History of failed electrical cardioversion
History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
History or family history of long QT syndrome.
History of ventricular tachycardia requiring drug or device therapy.
History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
Ejection fraction (EF) of 35% or less.
Intervention: Tenofovir disoproxil
Trial phase: Phase 2 | Phase 3
ATC code: J05AF07 | J05AF13 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR11 | J05AR12 | J05AR24 | J05AR27
SMILES: [H][C@@](C)(Cn1cnc2c(N)ncnc21)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 189
Group description: 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery

1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:

Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or
The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).
Eligibility criteria:
Inclusion Criteria:

Age 18 years and older
Women who previously participated in an ARV prevention study
Currently utilizing or agreeing to attend designated public sector family planning services
Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
Able and willing to provide adequate locator information for study retention purposes
Sexually active (at least one coital act in the last 3 months prior to screening)
HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
Negative pregnancy test performed by study staff within 21 days of enrollment
Agree to use a non-barrier form of contraceptive
Agree to adhere to study visits and procedures

Exclusion Criteria:

Has a creatinine clearance < 50ml/min
Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Intervention: Tenofovir disoproxil
Trial phase: Phase 2 | Phase 3
ATC code: J05AF07 | J05AF13 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR11 | J05AR12 | J05AR24 | J05AR27
SMILES: [H][C@@](C)(Cn1cnc2c(N)ncnc21)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 183
Group description: monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics

1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:

Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or
The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).
Eligibility criteria:
Inclusion Criteria:

Age 18 years and older
Women who previously participated in an ARV prevention study
Currently utilizing or agreeing to attend designated public sector family planning services
Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
Able and willing to provide adequate locator information for study retention purposes
Sexually active (at least one coital act in the last 3 months prior to screening)
HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
Negative pregnancy test performed by study staff within 21 days of enrollment
Agree to use a non-barrier form of contraceptive
Agree to adhere to study visits and procedures

Exclusion Criteria:

Has a creatinine clearance < 50ml/min
Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives