anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Enclomiphene
Trial phase: Phase 3
ATC code: G03GB02
SMILES: CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 207
Group description: Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Eligibility criteria:
Inclusion Criteria:

Secondary hypogonadal males between the ages of 18 and 65
Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men age 55-65
LH < 15mIU/mL (at Visit 1 only)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent.

Exclusion Criteria:

Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year
Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication.
Known hypersensitivity to Clomid
Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
Current or history of breast cancer
Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA > 3.6
Presence or history of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects know to be positive for HIV
End stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Enrollment in a previous Androxal study
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A)
Eligibility criteria:
Inclusion Criteria:

Healthy men and non-childbearing potential women
Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2)
Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

Taking over-the-counter or prescription medication with the exception of vitamins or minerals
Smoke more than 10 cigarettes per day
Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 140 mg LY2886721: single oral dose (Cohort C)
Eligibility criteria:
Inclusion Criteria:

Healthy men and non-childbearing potential women
Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2)
Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

Taking over-the-counter or prescription medication with the exception of vitamins or minerals
Smoke more than 10 cigarettes per day
Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
Eligibility criteria:
Inclusion Criteria:

Female
Age 18 or older
Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
Surgery being performed for benign disease

Exclusion Criteria:

Male
Women under 18 years old
Pregnancy
Suspected or known malignant disease
Immunocompromised
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
Eligibility criteria:
Inclusion Criteria:

Female
Age 18 or older
Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
Surgery being performed for benign disease

Exclusion Criteria:

Male
Women under 18 years old
Pregnancy
Suspected or known malignant disease
Immunocompromised
Intervention: Psilocybin
Trial phase: Phase 2
SMILES: CN(C)CCc1c[nH]c2cccc(OP(=O)(O)O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: This was a single-arm study. All participants were assigned to receive the same schedule of psychotherapy and psilocybin administration, as described in the Protocol section. Arms/Groups cannot be provided for each dose level separately because information was not collected.
Eligibility criteria:
Inclusion Criteria:

Males and females age 25-65 with diagnosis of alcohol dependence, as ascertained using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV version);
Concerned about their drinking, but not planning to pursue any other form of treatment at present (12-step meetings are not considered treatment);
Able to provide voluntary informed consent;
Having at least 2 heavy drinking days in the past 30 days;
Willing to commit to the goal of abstinence at least from the time of the first psilocybin administration session until the end of treatment.
At least 24 hours abstinence from alcohol at the time of the psilocybin administration sessions;
If female of childbearing potential, willing to use approved form of contraception from screening until after the psilocybin administration sessions;
Having a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions; and
Able to provide adequate locator information.

Exclusion Criteria:

Exclusionary medical conditions (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, uncontrolled hypertension, history of cerebrovascular accident, severe obesity (BMI greater than or equal to 35);
Exclusionary psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder, current major depression, current post-traumatic stress disorder, current suicidality);
A family history of schizophrenia, schizoaffective disorder, bipolar disorder, or suicide (first or second degree relatives);
Lifetime history of hallucinogen use on more than 10 occasions, or any use in the past 30 days;
Cocaine, psychostimulant, or opioid dependence (past 12 months) or current (past 30 days) use;
A history of medically significant suicide attempt or violent crime;
Significant alcohol withdrawal (CIWA-Ar score greater than 7);
Exclusionary laboratory abnormalities (any liver function test (LFT) greater than 5 times normal, ECG evidence of ischemia, serious abnormalities of complete blood count or chemistries);
Active legal problems with the potential to result in incarceration;
Pregnancy or lactation;
The need to take excluded medication (e.g., antidepressants, antipsychotics, psychostimulants, pharmacologic treatments for addictions).
High risk of adverse emotional reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of meaningful social support).
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Intravaginal insertion of 4mL 2% lidocaine gel

Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel
Eligibility criteria:
Inclusion criteria:

Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
No history of pregnancy in the last 6 weeks
Able to provide written informed consent in English and comply with all study procedures

Exclusion criteria:

Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
Prior failed IUD insertion
Prior IUD use
Use of narcotic or benzodiazepine medication within the last 24 hours
U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period
Intervention: Ketamine
Trial phase: Phase 1 | Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 27
Group description: 0.5 mg/kg of ketamine IV over 40 minutes

Ketamine: 0.5 mg/kg IV over 40 minutes
Eligibility criteria:
Inclusion Criteria:

Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening
Physically healthy
No adverse reactions to study medications
21-60 years of age
Capacity to consent and comply with study procedures, including sufficient proficiency in English
Seeking treatment

Exclusion Criteria:

Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score > 12.
Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
Current suicide risk or a history of suicide attempt within the past year
Pregnant or interested in becoming pregnant during the study period
Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), WBC < 3.5, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creatinine > 2, BUN >40), or untreated diabetes
Previous history of ketamine or benzodiazepine misuse or abuse, and a history of an adverse reaction/experience with prior exposure to ketamine or benzodiazepine
Recent history of significant violence (past 2 years)
First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
BMI > 32, or a history of documented obstructive sleep apnea
On psychotropic or other medications whose effect could be disrupted by participation in the study
Patients who cannot comply with study procedures during the initial hospitalization phase
Intervention: Midazolam
Trial phase: Phase 1 | Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 0.025 mg/kg IV over 40 minutes

Midazolam: 0.025 mg/kg IV over 40 minutes
Eligibility criteria:
Inclusion Criteria:

Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening
Physically healthy
No adverse reactions to study medications
21-60 years of age
Capacity to consent and comply with study procedures, including sufficient proficiency in English
Seeking treatment

Exclusion Criteria:

Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score > 12.
Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
Current suicide risk or a history of suicide attempt within the past year
Pregnant or interested in becoming pregnant during the study period
Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), WBC < 3.5, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creatinine > 2, BUN >40), or untreated diabetes
Previous history of ketamine or benzodiazepine misuse or abuse, and a history of an adverse reaction/experience with prior exposure to ketamine or benzodiazepine
Recent history of significant violence (past 2 years)
First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
BMI > 32, or a history of documented obstructive sleep apnea
On psychotropic or other medications whose effect could be disrupted by participation in the study
Patients who cannot comply with study procedures during the initial hospitalization phase
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Infusion of ketamine

Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case
Eligibility criteria:
Inclusion Criteria:

ASA I,II
Age 18-64
Females undergoing surgical procedures requiring sedation

Exclusion Criteria:

Pregnant subjects
Breastfeeding

Patients or surgeon request

---Drop Out:

Patient or surgeon request,
Conversion to general anesthesia
Inability to obtain data from Co2 monitor
Intervention: Acetylcysteine
Trial phase: Phase 1
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: N-acetylcysteine 600mg by mouth every 12 hours for 90 days. N-acetylcysteine 1200mg by mouth every 12 hours for 270 days

N-acetylcysteine: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.
Eligibility criteria:
Inclusion Criteria:

Patients with primary cardiac hypertrophy, non-dilated LV cavity and preserved LV systolic function, hence, the diagnosis of HCM, who have at least an LV end diastolic (LVSD) wall thickness of at least 15 mm on a 2D echocardiogram and
Known to have mutations in genes encoding sarcomeric proteins

Exclusion Criteria:

Hypersensitivity to NAC
Individuals younger than 18 years old (in the pilot study)
Phenocopy conditions, diagnosed clinically or genetically
Patients who have undergone transcatheter (alcohol) septal ablation within 6 months.
Individuals (typically family members) with causal mutations but an LVSD wall thickness of <15 mm

Patients with concomitant diseases such as:

Significant coronary artery disease >70% luminal diameter stenosis in ny of the major coronary arteries (if known);
Valvular heart diseases (more than mild aortic stenosis and mitral regurgitation, the latter judged to be due to primary mitral valve abnormalities);

Uncontrolled hypertension, defined as systolic blood pressure of

140 mmHg and diastolic blood pressure of ≥90 mmHg on medication, mean of three measurements at rest);
Other significant medical problems, such as moderate to severe chronic renal failure (GFR<45 ml/min/1.73m2), advanced liver disease, cancer, or other disabling conditions
Pregnant women, nursing mothers and those who plan pregnancy during the study period
Those with active asthma (albeit the concern is relevant to nebulizer form but not oral formulations)
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.

Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Eligibility criteria:
Inclusion Criteria:

Patients age 18-59 who present to the Brooke Army Medical Center Emergency Department with acute (less than 10 days) abdominal pain, flank/lumbar back pain and or/pain to the extremities, and of sufficient severity in the judgement of the ED treating physician or PA to warrant use of intravenous opioids

Exclusion Criteria:

Poor vital sign stability hypoxia: Sats<95% hypotension: SBP<90 hypertension: SBP>180 heart rate: <50 or >120 respiratory rate: <10 or >30
Altered mental status or intoxication
Patient is unwilling to participate or provide informed consent
History of chronic pain or pain syndrome with concurrent opioid medication use
fibromyalgia
Patient has received opioids and/or tramadol in the past 4 hours
Prescription pain medication use (to exclude muscle relaxants, acetaminophen or NSAIDs including toradol) in the past 4 hours
Allergy to morphine or ketamine
Sole provider status
Adverse reaction to morphine or ketamine in the past
Patients, who in the opinion of the triage nurse, require immediate analgesic relief
Patient is female of child-bearing age and unable to provide urine or serum for HCG analysis in triage
Pregnancy or breast feeding
Presence of oxygen dependent pulmonary disease, liver cirrhosis or Renal disease requiring dialysis. (as assessed by electronic chart review)
Presence of Ischemic heart disease, heart failure or unstable dysrhythmias (as assessed by electronic chart review)
Presence of intracranial mass or vascular lesion.
Presence of psychosis or hallucinations
Weight greater than 115kg or less than 45 kg
History of acute ocular/head trauma
History of increased intracranial pressure/hypertensive hydrocephalus
Non-English speaking patients
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.

Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Eligibility criteria:
Inclusion Criteria:

Patients age 18-59 who present to the Brooke Army Medical Center Emergency Department with acute (less than 10 days) abdominal pain, flank/lumbar back pain and or/pain to the extremities, and of sufficient severity in the judgement of the ED treating physician or PA to warrant use of intravenous opioids

Exclusion Criteria:

Poor vital sign stability hypoxia: Sats<95% hypotension: SBP<90 hypertension: SBP>180 heart rate: <50 or >120 respiratory rate: <10 or >30
Altered mental status or intoxication
Patient is unwilling to participate or provide informed consent
History of chronic pain or pain syndrome with concurrent opioid medication use
fibromyalgia
Patient has received opioids and/or tramadol in the past 4 hours
Prescription pain medication use (to exclude muscle relaxants, acetaminophen or NSAIDs including toradol) in the past 4 hours
Allergy to morphine or ketamine
Sole provider status
Adverse reaction to morphine or ketamine in the past
Patients, who in the opinion of the triage nurse, require immediate analgesic relief
Patient is female of child-bearing age and unable to provide urine or serum for HCG analysis in triage
Pregnancy or breast feeding
Presence of oxygen dependent pulmonary disease, liver cirrhosis or Renal disease requiring dialysis. (as assessed by electronic chart review)
Presence of Ischemic heart disease, heart failure or unstable dysrhythmias (as assessed by electronic chart review)
Presence of intracranial mass or vascular lesion.
Presence of psychosis or hallucinations
Weight greater than 115kg or less than 45 kg
History of acute ocular/head trauma
History of increased intracranial pressure/hypertensive hydrocephalus
Non-English speaking patients
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: GCSF 10mcg/kg/d SQ for 7 days

Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days
Eligibility criteria:
Inclusion Criteria:

Each patient must have the diagnosis of severe generalized recessive dystrophic EB (formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either of the following:

transmission electron microscopy
immunofluorescence antigenic mapping and type VII collagen monoclonal antibody staining
COL7A1 mutational analysis

Exclusion Criteria:

The patient must not have a history of squamous cell carcinoma or any internal malignancy.
Female patients who are pregnant.
Patients with active signs and symptoms of infection.