anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lopinavir
Trial phase: Phase 4
ATC code: J05AR10
SMILES: Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients taking lopinavir/ritonavir and tenofovir once daily.

Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
Eligibility criteria:
Inclusion Criteria:

Male or female patients >18 years of age with documented HIV-1 infection
Naïve to antiretroviral therapy
Able and willing to provide written informed consent
No CD4 restriction
HIV-1 RNA levels >5000 c/mL

Female patients must meet these additional criteria

Non-childbearing potential
Negative serum pregnancy test at screen
Willingness to abstain from sexual intercourse or use double barrier contraception

Exclusion Criteria:

Presence of any of the following:

Aminotransferases >3xULN
Hemoglobin concentration <8.0g/dl
Absolute neutrophil count <800 cells/cubic mm
Platelet count <50,000 cells/cubic mm
Acute illness, or an acute illness ≤7 days
Presence of Opportunistic Infection, or an OI within 30 days of screening
Acute or chronic active Hepatitis B
Hepatitis C
Creatinine Clearance <50 mL/min
Pregnant or breast-feeding women
Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.
Intervention: rhEPO
Trial phase: Phase 2
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Eligibility criteria:
Inclusion Criteria

On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
Two consecutive hemoglobin values of ≥ 8.0 g/dL and < 11.0 g/dL within the 4 weeks prior to randomization.

Exclusion Criteria

Females who are pregnant or breast-feeding.
Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
Known bleeding or coagulation disorder.
Known hematologic disease or cause for anemia other than renal disease
Poorly controlled hypertension.
Evidence of active malignancy within one year.
A scheduled kidney transplant.
Intervention: Benfotiamine
Trial phase: Phase 4
ATC code: A11DA03
SMILES: CC(=C(CCOP(=O)(O)O)SC(=O)c1ccccc1)N(C=O)Cc1cnc(C)nc1N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Problem drinking in the last 30 days

Exclusion Criteria:

Prolonged abstinence
Serious medical problems
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Eligibility criteria:
Inclusion Criteria:

age 6 months-23 years
documented central line infection with bacteria or fungus (positive blood culture)

Exclusion Criteria:

allergy or intolerance to ethanol
pregnant or breastfeeding
central line tunnel or exit site infection
Intervention: EDETIC ACID
Trial phase: Phase 3
SMILES: O=C(O)CN(CCN(CC(=O)O)CC(=O)O)CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Eligibility criteria:
Inclusion Criteria:

age 6 months-23 years
documented central line infection with bacteria or fungus (positive blood culture)

Exclusion Criteria:

allergy or intolerance to ethanol
pregnant or breastfeeding
central line tunnel or exit site infection
Intervention: Testosterone
Trial phase: Not Applicable
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: +Testosterone, -Estrogen

Testosterone: Testosterone gel
Eligibility criteria:
Inclusion Criteria:

males age 60-85 years
non-diabetic fasting glucose and 2-hour oral glucose tolerance test (OGTT)
overall good general medical health and signed informed consent
willing to travel to West Los Angeles VA and University of California, Los Angeles in Los Angeles, California

Exclusion Criteria:

any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. prostate specific antigen > 4)
or other symptom or history of a significant underlying medical or psychiatric illness
BMI < 20 or > 40
subjects already on testosterone therapy or medications that might influence glucose regulation or hormone levels
subjects with a history of deep venous thromboses, pulmonary embolism, breast cancer, prostate cancer, polycythemia or other contraindications to estrogen or testosterone
Intervention: Estradiol
Trial phase: Not Applicable
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: -Testosterone, +Estrogen

Estrogen: Estrogen patch
Eligibility criteria:
Inclusion Criteria:

males age 60-85 years
non-diabetic fasting glucose and 2-hour oral glucose tolerance test (OGTT)
overall good general medical health and signed informed consent
willing to travel to West Los Angeles VA and University of California, Los Angeles in Los Angeles, California

Exclusion Criteria:

any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. prostate specific antigen > 4)
or other symptom or history of a significant underlying medical or psychiatric illness
BMI < 20 or > 40
subjects already on testosterone therapy or medications that might influence glucose regulation or hormone levels
subjects with a history of deep venous thromboses, pulmonary embolism, breast cancer, prostate cancer, polycythemia or other contraindications to estrogen or testosterone
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.

Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Eligibility criteria:
Inclusion Criteria:

Chief complaint of headache
Age 7-17 years

Exclusion Criteria:

Presence of fever
meningismus
headache that wakes the child at night
known organic brain disease, mass, or tumor
history of stroke
history of allergy to ropivacaine or other aminoacyl local anesthetics
history of liver disease
history of impaired cardiac function
abnormal neurologic signs
a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome
cognitive inability to communicate the intensity of pain.
history of shunt or other intracranial hardware
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.

Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Eligibility criteria:
Inclusion Criteria:

Chief complaint of headache
Age 7-17 years

Exclusion Criteria:

Presence of fever
meningismus
headache that wakes the child at night
known organic brain disease, mass, or tumor
history of stroke
history of allergy to ropivacaine or other aminoacyl local anesthetics
history of liver disease
history of impaired cardiac function
abnormal neurologic signs
a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome
cognitive inability to communicate the intensity of pain.
history of shunt or other intracranial hardware
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: These patients have IBS and are receiving the rifaximin 550mg twice a day
Eligibility criteria:
Inclusion Criteria:

Men and women age 32-75 years
Rome III criteria for diarrhea-predominant IBS
Symptom onset after an apparent episode of acute gastroenteritis
Symptoms of > 3 months duration
Normal endoscopic appearance of the colonic mucosa
Negative markers for celiac disease and inflammatory bowel disease.
Normal thyroid function and serum calcium levels.
Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)

Exclusion Criteria:

Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
History of/or presence of systemic malignancy
Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
Current effects of drug or alcohol abuse
Investigator perception of patients inability to comply with study protocol
Unstable psychiatric disease
Recent change in gastrointestinal medications
Subjects with a positive pregnancy test
Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Intervention: Alendronate Sodium
Trial phase: Phase 3
SMILES: NCCCC(O)(P(=O)([O-])O)P(=O)(O)O.O.O.O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 242
Group description: Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
Eligibility criteria:
Inclusion Criteria:

Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

Exclusion Criteria:

Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism
Intervention: PROPYLENE GLYCOL
Trial phase: Not Applicable
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
symptoms of dry eye
no other history of ophthalmic problems

Exclusion Criteria:

Use of any ocular lubricant or ointment in the past 36 hours
use of contact lenses or excessive eye lid cosmetics on the study day
Intervention: Quetiapine
Trial phase: Phase 2
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Eligibility criteria:
Inclusion Criteria:

Provision of signed informed consent.
Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

Woman with pre-existing psychotic disorder
Patients with alcohol or substance abuse or dependence
Patients who pose an imminent risk of suicide or danger to self or others
Intervention: Zinc
Trial phase: Phase 2
ATC code: C05AX04
SMILES: [Zn]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: 54 participants received Zinc first and 45 participants received Zinc after 1 month washout. The total number of participants at risk to Zinc is 99.
Eligibility criteria:
Inclusion Criteria:

60 years of age or older
Tinnitus for 6 months or more
Normal copper levels
Be generally healthy

Exclusion Criteria:

Have a treatable otological disorder
Involved in litigation
Have or are suspected of having a serious psychiatric problem
Involved in other treatments for tinnitus
Are taking drugs which might interact with zinc and result in tinnitus
Have copper deficiency
Have Zinc levels above normal
Are cognitively impaired.
Intervention: Diazoxide
Trial phase: Not Applicable
ATC code: C02DA01 | G01AE10 | V03AH01
SMILES: CC1=NS(=O)(=O)c2cc(Cl)ccc2N1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: PCOS subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days
Eligibility criteria:
Inclusion Criteria:

Obese women with PCOS and normal women aged 18-40,
PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
Normal regular monthly periods, no clinical evidence of androgen excess,
All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements

Exclusion Criteria:

DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
Intervention: Diazoxide
Trial phase: Not Applicable
ATC code: C02DA01 | G01AE10 | V03AH01
SMILES: CC1=NS(=O)(=O)c2cc(Cl)ccc2N1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Normal subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days
Eligibility criteria:
Inclusion Criteria:

Obese women with PCOS and normal women aged 18-40,
PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
Normal regular monthly periods, no clinical evidence of androgen excess,
All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements

Exclusion Criteria:

DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
Eligibility criteria:
Inclusion Criteria:

Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
Regular or steady menstrual cycle lasting from 24 to 36 days
Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

Documented endometriosis or active pelvic inflammatory disease
History of alcohol and/or drug abuse
Any history or diagnosis of gynecological cancer or cervical dysplasia
Use of an IUD

Use of prohibited concomitant medications:

Use of Depo-Provera must cease 10 months prior to first dose of study drug
Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
Eligibility criteria:
Inclusion Criteria:

Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
Regular or steady menstrual cycle lasting from 24 to 36 days
Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

Documented endometriosis or active pelvic inflammatory disease
History of alcohol and/or drug abuse
Any history or diagnosis of gynecological cancer or cervical dysplasia
Use of an IUD

Use of prohibited concomitant medications:

Use of Depo-Provera must cease 10 months prior to first dose of study drug
Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Intervention: Leuprolide Acetate
Trial phase: Phase 2
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
Eligibility criteria:
Inclusion Criteria:

Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
Regular or steady menstrual cycle lasting from 24 to 36 days
Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

Documented endometriosis or active pelvic inflammatory disease
History of alcohol and/or drug abuse
Any history or diagnosis of gynecological cancer or cervical dysplasia
Use of an IUD

Use of prohibited concomitant medications:

Use of Depo-Provera must cease 10 months prior to first dose of study drug
Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Intervention: Buprenorphine
Trial phase: Phase 2 | Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Buprenorphine Unobserved at home induction

Buprenorphine: Dose is determined according to the participants' individual need.
Eligibility criteria:
Inclusion Criteria:

DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
Recent opioid use
Individuals must describe opioids as their primary drug of abuse.
18-65 years of age
Able to give informed consent and comply with study procedures
Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)

Exclusion Criteria:

DSM-IV opioid dependence without physical dependence
Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
Individuals who are significant risk for suicide based on their current mental state or history.
DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
Unstable physical disorder that might make participation hazardous.
Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.
Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)
Current buprenorphine maintenance
Current long-acting opioid use (e.g., methadone)
Inability to read or understand the self-report assessment forms unaided