anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sodium stibogluconate
Trial phase: Phase 1 | Phase 2
ATC code: P01CB02
SMILES: O.O.O.O.O.O.O.O.O.[H][C@]1([C@H](O)CO)O[Sb]2([O-])(O[Sb]34(O)O[C@@H](C(=O)[O-])[C@@]([H])(O3)[C@@]([H])([C@H](O)CO)O4)O[C@@H](C(=O)[O-])[C@@]1([H])O2.[Na+].[Na+].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Eligibility criteria:
Inclusion Criteria:

DoD healthcare beneficiary of any age and gender.
Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.
Able to provide informed consent or assent (children).
All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG.

Exclusion Criteria:

Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.
History of hypersensitivity to pentavalent antimonials.

Any of the following on screening examination:

QTc interval greater or equal to 0.5 sec
Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)
History of recurrent pancreatitis
Liver failure or active hepatitis with transaminases > 3x upper limit of normal
Renal failure or creatinine > 2.5 mg/dL
Thrombocytopenia (platelets <100,000/mm^3)
White blood cell count < 2000 / mm^3
Hematocrit < 30 %
Intervention: Deferoxamine
Trial phase: Not Applicable
ATC code: V03AC01
SMILES: CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Histologically confirmed acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome
Planned allogeneic stem cell transplantation with myeloablative conditioning regimen; the planned date of transplantation must be at least 4 weeks from time of enrollment
Severe iron overload as defined by BOTH: Ferritin greater than 1000ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 5mg/g dry weight by MRI (at the time of donor availability)
Patients with a history of prior autologous transplantation will be eligible for this study

Exclusion Criteria:

Contraindication to magnetic resonance imaging (MRI)
Creatinine >2.0mg/dl or creatinine clearance <50ml/min
Active uncontrolled bacterial or fungal infection
History of mucormycosis
Pre-existing clinically apparent retinal neuropathy. If patients have clinically apparent visual loss at the time of screening, they will be excluded if either they have known retinal neuropathy or if this cannot be excluded by further testing
Pre-existing clinically apparent sensorineural hearing loss. If patients have auditory loss at the time of screening, they will be excluded if either they have known sensorineural hearing loss, or if this cannot be excluded by further testing
Pregnancy or inability or unwillingness to use contraception during the time of the study
Lactating patients
Inability to provide informed consent
Intervention: Nepicastat
Trial phase: Phase 2
SMILES: NCc1c[nH]c(=S)n1[C@H]1CCc2c(F)cc(F)cc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Arm 2

Nepicastat: 100-800mg
Eligibility criteria:
Inclusion Criteria:

Signed informed consent
Patient understands the risks and benefits and agrees to visit frequency and procedures
Male or female
Any race or ethnic origin
Served in OIF/OEF or Afghanistan conflicts or other Southwest Asia conditions
Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
Diagnosis of PTSD (by MINI (Mini International Neuropsychiatric Interview) and CAPS-DX (Clinician Administered PTSD scale- Diagnostic Form) using Rule of Fours and total CAPS-DX score of 45)
No substance use disorders in the previous 2 weeks and no substance dependence disorders in the past 4 weeks (except for nicotine and caffeine)
Free of psychotropic medication for 2 weeks prior to randomization
Physical and laboratory panel are within normal limits or not clinically significant
Women of childbearing potential must be using medically-approved methods of birth control
≥19 to 65 years of age

Exclusion Criteria:

Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
Actively considering plans of suicide or homicide
Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
Unstable general medical conditions or a contraindication to the use of nepicastat
Women planning to become pregnant or breastfeed during the study
Current or pending incarceration
Terminal Illness
Intervention: Morphine Sulfate
Trial phase: Not Applicable
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: morphine given traditionally (IV, pill, patch)

morphine sulfate: This is morphine given in the traditional methods.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

Histologically confirmed adenocarcinoma of the pancreas

Mixed adenocarcinoma tumors allowed provided the predominant invasive component of the tumor is adenocarcinoma
Locally advanced, unresectable, or metastatic disease
Patients must be within two months of diagnosis or have started chemotherapy within 60 days of study
Average pain score ≥ 4/10 over a 7-day period on a verbal numerical rating scale

Exclusion criteria:

Known brain metastases
Tumor with clinically significant obstruction of the spinal canal

PATIENT CHARACTERISTICS:

Inclusion criteria:

Karnofsky performance status 60-100%
ANC ≥ 1,500 cells/mm³
Hematocrit ≥ 28%
WBC ≥ 3,500 cells/mm³
Platelets ≥ 90,000/mm³
Serum creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.5 mg/dL
AST/ALT ≤ 5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times ULN
INR ≤ 1.5
Not pregnant or nursing
Negative pregnancy test
Mini-mental status exam score ≥ 22

Exclusion criteria:

Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Active peptic ulcer disease
Active infections
Insensitive to opioid medication for cancer pain
Insufficient tissue or decubitus ulcer near device implantation site
Current history of substance abuse

PRIOR CONCURRENT THERAPY:

Minor procedures (i.e., dental work or skin biopsy), tumor biopsies, and biliary stent placement are allowed
No prior surgical procedures affecting absorption
Prior or other concurrent pain medications are allowed
Concurrent chemotherapy or radiotherapy allowed at the discretion of the treating physician
Intervention: Efavirenz
Trial phase: Not Applicable
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
Eligibility criteria:
Inclusion Criteria:

willing to sign consent form
no known GI pathology
no anticipated antiretroviral therapy adjustments or changes
males & females between the ages of 18 & 50 years
no active opportunistic infections (OI) or therapy for OI within 30 days of entry
can be on secondary prophylaxis with a history of AIDS defining illness
per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study

Exclusion Criteria:

abnormal coagulation parameters (PT > or equal to 1.2 ULN)
thrombocytopenia (platelet count < 50,000 within 6 weeks)
contra-indications to upper endoscopy or conscious sedation
anemia (> or equal to grade 1)
aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy
Intervention: Minocycline hydrochloride
Trial phase: Phase 3
SMILES: CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: 1 mg microspheres of minocycline hydrochloride
Eligibility criteria:
Inclusion Criteria:

21 years of age and good general health
appropriately documented Informed Consent
willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
female subjects must meet the pregnancy and contraceptive requirements
must have oral health appropriate for study inclusion

Exclusion Criteria:

oral health inappropriate for study inclusion
females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
reporting any of the following conditions:
allergy to a tetracycline-class drug
systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Eligibility criteria:
Inclusion Criteria:

Clinically proven MGUS associated neuropathy with a Total Neuropathy Score (TNS) ≥5 (determined by exam, history and confirmatory EDX testing in association with MGUS (IgM,IgG,IgA))
Disease duration less than or equal to 8 years
Able to take Plavix 75mg/day or aspirin 325 mg daily as prophylactic anticoagulation. (patients currently taking warfarin with a stable INR may stay on current dose)

Exclusion Criteria:

Patients previously treated with thalidomide
Patients previously treated with lenalidomide
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Known positive for HIV or infectious hepatitis, type A, B or C
Medical history of deep venous thrombosis or hyper-coagulable state
Gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
Patients with dementia, other serious neurological diseases, uncompensated medical illness, substance abuse and debilitating psychiatric illness.
A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.
Medical conditions associated with neuropathy such as active thyroid disease, diabetes mellitus, and lupus, nutritional deficiencies, malignancy, human immunodeficiency virus infection, alcohol dependence, amyloidosis, or connective tissue diseases and Guillain-Barre Syndrome. Medications or toxic exposures known to cause neuropathy, or a family history of neuropathy will also be grounds for exclusion.
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
Subjects who are allergic to aspirin or Plavix (clopidogrel)
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 20-80 mg orally daily for 12 weeks
Eligibility criteria:
Inclusion criteria:

At least 18 years of age
Have major depression and are currently in a severe depressive episode
Have a degree of understanding such that patient can communicate with the investigator and study staff
All females must test negative for pregnancy
Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

Have not responded to duloxetine for depression in the past
Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
Are at significant risk for suicide
Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
Have a serious, unstable medical condition
Have a current or recent history of substance abuse or dependence
Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
Have started psychotherapy within 6 weeks prior to study entry
Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Intervention: Efavirenz
Trial phase: Not Applicable
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 73
Group description: Intermediate metabolizer
Eligibility criteria:
Inclusion Criteria:

Male and female subjects between 18 and 49 years old.
HIV negative. All potential subjects will be HIV tested at screening visit.
Healthy individuals without any significant medical condition.
Adherence to the study dietary restrictions.
Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study lasts for 30 days.
Ability to commit the time requested for this study.

Exclusion Criteria:

History or current HIV infection.
Life style that places you at a higher risk for contracting HIV (e.g. drug abuse, excessive alcohol drinking, and having multiple sexual partners).
Does not consent to HIV testing.
Underweight (weigh less than 52 kg or 114 lb) or overweight (body mass index (BMI) greater than 32).
History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).
History of intolerance or allergic reaction (e.g. rash) to efavirenz, midazolam, tolbutamide, caffeine, or omeprazole.
History or current significant health conditions such as heart, liver, or kidney.
History or current psychiatric illness such as depression, anxiety, or nervousness.
History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
Individuals having a serious infection within the last month.
Donation of blood within the past two months.
Blood hemoglobin less than 12.5 mg/dl.
Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intera-uterine device with hormones).
Females with a positive pregnancy test.
Breastfeeding.
Females of child-bearing potential who are unable or unwilling to either practice abstinence or use two non-hormonal forms of birth control (e.g. condom, contraceptive foams) up until the study completion, which will take a total of 30 days.
Participation in a research study or use of an investigational drug in the last two months.
An employee or student under supervision of any of the investigators of this study.
Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
Individuals with a gene type (DNA) that does not match one of the available genetic slot categories.
Intervention: Efavirenz
Trial phase: Not Applicable
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 73
Group description: Slow metabolizer
Eligibility criteria:
Inclusion Criteria:

Male and female subjects between 18 and 49 years old.
HIV negative. All potential subjects will be HIV tested at screening visit.
Healthy individuals without any significant medical condition.
Adherence to the study dietary restrictions.
Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study lasts for 30 days.
Ability to commit the time requested for this study.

Exclusion Criteria:

History or current HIV infection.
Life style that places you at a higher risk for contracting HIV (e.g. drug abuse, excessive alcohol drinking, and having multiple sexual partners).
Does not consent to HIV testing.
Underweight (weigh less than 52 kg or 114 lb) or overweight (body mass index (BMI) greater than 32).
History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).
History of intolerance or allergic reaction (e.g. rash) to efavirenz, midazolam, tolbutamide, caffeine, or omeprazole.
History or current significant health conditions such as heart, liver, or kidney.
History or current psychiatric illness such as depression, anxiety, or nervousness.
History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
Individuals having a serious infection within the last month.
Donation of blood within the past two months.
Blood hemoglobin less than 12.5 mg/dl.
Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intera-uterine device with hormones).
Females with a positive pregnancy test.
Breastfeeding.
Females of child-bearing potential who are unable or unwilling to either practice abstinence or use two non-hormonal forms of birth control (e.g. condom, contraceptive foams) up until the study completion, which will take a total of 30 days.
Participation in a research study or use of an investigational drug in the last two months.
An employee or student under supervision of any of the investigators of this study.
Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
Individuals with a gene type (DNA) that does not match one of the available genetic slot categories.
Intervention: Carvedilol Phosphate
Trial phase: Phase 4
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12.COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12.O.O=P(O)(O)O.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion Criteria:

Secondary forms of hypertension (including sleep apnea)
Patients currently treated with two or more antihypertensive drugs
Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
Isolated systolic hypertension
Other diseases requiring treatment with blood pressure lowering medications
Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
Known diabetes mellitus (Type 1 or 2)
Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
Primary renal disease
Pregnancy or lactation
History of Raynaud's syndrome
Alcoholism and recreational drug use (due to compliance concerns)
Intervention: Dicetrorelix pamoate
Trial phase: Phase 3
SMILES: CC(=O)NC(Cc1ccc2ccccc2c1)C(=O)NC(Cc1ccc(Cl)cc1)C(=O)NC(Cc1cccnc1)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(N)=O.CC(=O)NC(Cc1ccc2ccccc2c1)C(=O)NC(Cc1ccc(Cl)cc1)C(=O)NC(Cc1cccnc1)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(N)=O.O=C(O)c1cc2ccccc2c(Cc2c(O)c(C(=O)O)cc3ccccc23)c1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 528
Group description: Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Eligibility criteria:
Inclusion Criteria:

Benign Prostatic Hyperplasia, based on medical history
Voiding symptoms
Uroflow (max) 5-15mL/sec

Exclusion Criteria:

Urgent need for prostate surgery
History of allergic reaction to peptide
Major organ dysfunction
Prior surgical treatment of the prostate or bladder
Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months