anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
Ability to complete questionnaire(s) by themselves or with assistance
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
Provide informed written consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Stable dose of corticosteroid >= 14 days prior to registration
Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
Ability to complete questionnaire(s) by themselves or with assistance
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
Provide informed written consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Stable dose of corticosteroid >= 14 days prior to registration
Intervention: Aggrenox
Trial phase: Not Applicable
SMILES: CC(=O)Oc1ccccc1C(=O)O.OCCN(CCO)c1nc(N2CCCCC2)c2nc(N(CCO)CCO)nc(N3CCCCC3)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks

extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with SLE meeting the 1997 ACR Classification Criteria
Evidence of positive ANA or anti-dsDNA within one year of screening
SLEDAI ≥4 or ≥1 BILAG A or B at screening, despite standard of care

Exclusion Criteria:

Leukopenia (WBC <2.000/mm3) or lymphopenia (lymphocytes < 300/mm3)
AST or ALT >3 times above normal cut off values
Acute lupus nephritis defined as class II, IV or V nephritis diagnosed within 6 months or prot/creat > 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
Active CNS lupus affecting mental status
Pregnancy or breast feeding
Current requirement for anticoagulation
Contraindication to aspirin or dipyridamole, including history of recent or severe GI bleeding, hemoglobin <9 mg/dL, platelet count of <30,000 /mm3 or unstable platelet count
Any other medical condition, whether or not related to lupus which, in the opinion of the investigator would render the patient inappropriate or too unstable to complete the study protocol
Inability or unwillingness to understand and/or sign informed consent
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: half a tablet of a 81mg aspirin twice daily for 24 weeks

81mg aspirin: half a tablet twice daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with SLE meeting the 1997 ACR Classification Criteria
Evidence of positive ANA or anti-dsDNA within one year of screening
SLEDAI ≥4 or ≥1 BILAG A or B at screening, despite standard of care

Exclusion Criteria:

Leukopenia (WBC <2.000/mm3) or lymphopenia (lymphocytes < 300/mm3)
AST or ALT >3 times above normal cut off values
Acute lupus nephritis defined as class II, IV or V nephritis diagnosed within 6 months or prot/creat > 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
Active CNS lupus affecting mental status
Pregnancy or breast feeding
Current requirement for anticoagulation
Contraindication to aspirin or dipyridamole, including history of recent or severe GI bleeding, hemoglobin <9 mg/dL, platelet count of <30,000 /mm3 or unstable platelet count
Any other medical condition, whether or not related to lupus which, in the opinion of the investigator would render the patient inappropriate or too unstable to complete the study protocol
Inability or unwillingness to understand and/or sign informed consent
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 297
Group description: Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).

High Risk Cohort Criteria (one or more of the following has to be met):

No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
STI diagnosis during the last 12 months.
Previous PEP use during the last 12 months (* see exclusion criteria)
Has at least one HIV infected sexual partner for ≥4 weeks.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Able to understand and provide consent in English or Spanish
Self identified MSM, MSM/W, or Transfemale
At least one male sex partner for anal intercourse in the prior 12 months
HIV negative by enzyme immunoassay (EIA) and viral load (VL)
CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
No signs or symptoms suggestive of primary HIV infection (PHI).

Exclusion Criteria:

Participants <18 years of age
Unable to understand and provide consent in English or Spanish
Known or found on testing to be HIV positive
Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
Signs or symptoms suspicious for PHI.
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Able to understand and provide consent in English or Spanish
Self identified MSM, MSM/W, or Transfemale
At least one male sex partner for anal intercourse in the prior 12 months
HIV negative by enzyme immunoassay (EIA) and viral load (VL)
CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
No signs or symptoms suggestive of primary HIV infection (PHI).

Exclusion Criteria:

Participants <18 years of age
Unable to understand and provide consent in English or Spanish
Known or found on testing to be HIV positive
Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
Signs or symptoms suspicious for PHI.
Intervention: Esmolol
Trial phase: Not Applicable
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min

Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Eligibility criteria:
Inclusion Criteria:

- Female patients Undergoing outpatient hysteroscopic myomectomy surgery ASA PS I and II Age between 18 and 64 years Fluent in English

Exclusion Criteria:

History of allergy to beta-blocker History of chronic opioid use Pregnant patients BMI greater than 35 History of EKG abnormalities or cardiac arrhythmias Beta-blocker medication usage.

Dropout criteria: Patient or surgeon request, Conversion of the surgery from laparoscopic to open.
Intervention: Dextrose Monohydrate
Trial phase: Phase 2 | Phase 3
SMILES: O.O=CC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 72
Group description: Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.

5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients.
Eligibility criteria:
Inclusion Criteria:

Infants born at equal to or less than 30 weeks gestation and with birth weight < 1250 grams
Less than 72 hours of age
Signed parental consent

Exclusion Criteria:

Critically ill infants with life expectancy less than 72 hours
Inability to obtain consent within 72 hours of birth
Potentially life-threatening congenital anomalies
Known hereditary metabolic disorders
Known chromosomal abnormalities
Terratogen exposure with symptomatic substance withdrawal
Congenital viral infections
Microcephaly
Grade IV intraventricular hemorrhage or seizures documented within the first 72 hours of life
Intervention: Levocarnitine
Trial phase: Phase 2 | Phase 3
ATC code: A16AA01
SMILES: C[N+](C)(C)CC(O)CC(=O)[O-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 72
Group description: Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.

L-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.
Eligibility criteria:
Inclusion Criteria:

Infants born at equal to or less than 30 weeks gestation and with birth weight < 1250 grams
Less than 72 hours of age
Signed parental consent

Exclusion Criteria:

Critically ill infants with life expectancy less than 72 hours
Inability to obtain consent within 72 hours of birth
Potentially life-threatening congenital anomalies
Known hereditary metabolic disorders
Known chromosomal abnormalities
Terratogen exposure with symptomatic substance withdrawal
Congenital viral infections
Microcephaly
Grade IV intraventricular hemorrhage or seizures documented within the first 72 hours of life
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 362
Group description: BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit (SV).
A documented history of PAR to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study Screening Visit (SV).
A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
Other criteria apply.

Exclusion Criteria:

History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV]).
History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-In Period.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.
Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial.
Other criteria apply.
Intervention: Caffeine
Trial phase: Phase 4
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.

Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
Eligibility criteria:
Inclusion Criteria:

Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria:

Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
Intervention: Caffeine
Trial phase: Phase 4
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.

Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
Eligibility criteria:
Inclusion Criteria:

Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria:

Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.

Testosterone
Eligibility criteria:
Inclusion Criteria:

Female, age 21-75
Major depressive disorder including MADRS>/=12
Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.

Exclusion Criteria:

Serious suicide or homicide risk, as assessed by evaluating clinician
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
Currently treated with typical or atypical antipsychotic medications, or lithium
Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos
Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
Any investigational psychotropic drug within the last thirty days
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (>50%) in the past year)
ALT > 3x upper limit of normal or creatinine> 3x upper limit
History of a hormone-responsive cancer
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Phase 1 | Phase 2
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: 250 mg intravenous injection of Methylprednisolone for 3 days.
Eligibility criteria:
Inclusion Criteria:

Having indirect traumatic optic neuropathy, not more than 3 weeks between trauma and treatment, normal fundoscopy

Exclusion Criteria:

Having other injuries that effect on visual function, direct optic neuropathy, glaucoma, diabetic retinopathy, uncontrolled hypertension, polycythemia, creatinin more than 3 mg/dl, sensitivity to EPO, hyperkalemia, women who use contraceptive pill, pregnant and breast feeding women, history of stroke and cardiovascular diseases, having malignancy