anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oxcarbazepine
Trial phase: Phase 1
ATC code: N03AF02
SMILES: NC(=O)N1c2ccccc2CC(=O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9

Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)
Eligibility criteria:
Inclusion Criteria:

Healthy subjects
Aged 18-55 years
Body mass index (18.5-29 kg/m3)
Intervention: Eltrombopag
Trial phase: Phase 2
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Ten participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.
Eligibility criteria:
Inclusion Criteria:

Subject has signed and dated a written informed consent
Male or female adults (≥18 years) diagnosed with either primary ITP according to the American Society for Hematology or British Committee for Standards in Haematology (ASH/BCSH) guidelines [Blood, 1996; British Journal of Haematology, 2003] for at least three months prior to study entry or with ITP secondary to Evans syndrome, systemic lupus erythematosus (SLE), or Common Variable Immunodeficiency (including hypogammaglobulinemia).
Subjects must have responded with a platelet count > 30,000/µL to a previous ITP therapy including thrombopoietic agents.
Platelet count < 30,000/µL
Female subjects of childbearing potential are practicing an acceptable method of contraception or are completely abstinent from intercourse.

Exclusion Criteria:

Active infection
Previously treated with thrombopoietic agents IF either no response at a therapeutic dose (peak platelet count < 50k) OR treatment with the agent within the past 4 weeks
Currently treated with concomitant ITP medication that has not been stable in dose for at least 2 weeks - only prednisone, azathioprin, and danazol are allowed.
Female subjects who are nursing or pregnant
Thrombosis of any kind within past 6 months or on blood thinners because of thrombosis.
Intravenous Immunoglobulin (IVIG), IV anti-D, bolus corticosteroids or vinca alkaloids within the past week
Other cytotoxic or immunosuppressive ITP therapy within the past 8 weeks or rituximab within the past 12 weeks
Active non-dermatologic malignancy defined as presence of known tumor ie. visible by radiography or evident on blood or bone marrow testing OR receiving chemotherapy within past 2 months
Hemoglobin < 10 gm/dl or white blood cell count < 2,500/ul
Liver function tests (ALT, Aspartate Aminotransferase (AST), or total bilirubin) > three times upper limit of normal (ULN)
Creatinine > two times upper limit of normal (ULN)
Intervention: Palonosetron Hydrochloride
Trial phase: Phase 2
SMILES: Cl.O=C1c2cccc3c2C(CCC3)CN1C1CN2CCC1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma

Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen

Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2
No brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
Able to complete questionnaire(s) alone or with assistance
Willing to return to NCCTG enrolling institution for follow-up
Able to reliably take oral medication (for purposes of rescue medication)
No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists
No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No nausea ≤ 48 hours prior to study enrollment
No history of dystonic reactions to prochlorperazine or haloperidol or related agents

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

More than 7 days since prior agents known to have significant effects on emesis, including the following:

Ondansetron
Sedating antihistamines
Antipsychotics
Cannabinoids
Corticosteroids
Metoclopramide
Narcotic analgesics
Benzodiazepines
More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer
More than 7 days since of prior cetuximab
More than 7 days since prior and no concurrent oral steroids
No prior palonosetron hydrochloride
Intervention: Palonosetron Hydrochloride
Trial phase: Phase 2
SMILES: Cl.O=C1c2cccc3c2C(CCC3)CN1C1CN2CCC1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma

Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen

Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2
No brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
Able to complete questionnaire(s) alone or with assistance
Willing to return to NCCTG enrolling institution for follow-up
Able to reliably take oral medication (for purposes of rescue medication)
No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists
No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No nausea ≤ 48 hours prior to study enrollment
No history of dystonic reactions to prochlorperazine or haloperidol or related agents

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

More than 7 days since prior agents known to have significant effects on emesis, including the following:

Ondansetron
Sedating antihistamines
Antipsychotics
Cannabinoids
Corticosteroids
Metoclopramide
Narcotic analgesics
Benzodiazepines
More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer
More than 7 days since of prior cetuximab
More than 7 days since prior and no concurrent oral steroids
No prior palonosetron hydrochloride
Intervention: Etravirine
Trial phase: Phase 2
ATC code: J05AG04
SMILES: Cc1cc(C#N)cc(C)c1Oc1nc(Nc2ccc(C#N)cc2)nc(N)c1Br
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
Eligibility criteria:
Inclusion Criteria:

Documented HIV-1 infection
In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection
Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection
HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)
Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening

Exclusion Criteria:

Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance
Known infection with HIV-2 or with HIV-1 group O
Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive
Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured
Specific grade 3 or 4 laboratory abnormalities
Intervention: Liothyronine
Trial phase: Not Applicable
ATC code: H03AA02 | H03AA03
SMILES: NC(Cc1cc(I)c(Oc2ccc(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 51
Group description: All participants receive placebo, followed by 25 mcg of T3.
Eligibility criteria:
Inclusion Criteria:

Age 18-50
Meet american college of rheumatology criteria for fibromyalgia
at baseline report an average pain of 4 or more on a brief Pain Inventory.
can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

new medication change in the last 2 months
any cardiac disease at all
known thyroid disease before or after thyroid screening bloodwork
unstable medical or psychiatric disease.
Known inflammatory or rheumatic disease other than fibromyalgia
substance abuse in the last year
suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
concomitant herbal medications
multiple severe medication allergies
the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
diabetes
smoking
Known uncontrolled hypertension
known uncontrolled hypercholesterolemia
Intervention: Eltrombopag
Trial phase: Phase 1
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Eltrombopag: dose escalation
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18
Able to give written informed consent for a clinical trial
Scheduled to undergo an autologous or an allogeneic stem cell transplantation from a sibling, related donor, or unrelated donor using a conditioning regimen containing at least 400 cGy TBI

Transplantation is being performed for one of the following medical conditions:

Acute myelogenous leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia in chronic, accelerated, or blastic phase
Myelodysplastic syndrome
Myeloproliferative diseases such as chronic myelomonocytic leukemia, agnogeneic myeloid metaplasia with myelofibrosis, polycythemia vera, or essential thrombocythemia
Hodgkin's lymphoma
Non-Hodgkin's lymphoma
Multiple myeloma
Chronic lymphocytic leukemia
Other malignancies or marrow disease such as aplastic anemia where transplant would be appropriate with approval of principal investigator
Patients with therapy-related AML or MDS may be included if their prior malignancy has been in remission for at least 12 months. If the remission is less than 12 months, approval of the principal investigator is required. Entry could be allowed if the malignancy is controlled and not expected to relapse e.g. localized prostate cancer treated with XRT.
Patients must meet all other pre-transplantation criteria of the transplant center including acceptable tests of heart, liver, kidney, and lung function (Standard screening for HSCT per PI, and co-investigators).
Karnofsky performance status must be ≥70%.

Exclusion Criteria:

TBI dose less than 400 cGY
Cord blood transplantation
HIV infection
Pregnancy or breastfeeding
Creatinine or bilirubin or ALT or AST greater than two times the upper limit of normal, unless the abnormal bilirubin is due to Gilbert's syndrome
Active infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents
Concomitant enrollment in another therapeutic clinical study except with PI approval
Must not have previously received eltrombopag
Patients with moderate or severe liver disease (ALT, AST, or bilirubin ≥ 2X the upper limit of normal, unless the abnormal bilirubin is due to Gilbert's syndrome) will be excluded
Patients with high risk of thromboembolism based on genetic syndromes , or past thromboembolic disease in the past 6 months will be excluded from the study, with the exception of those with catheter related clots
Intervention: Calcitriol
Trial phase: Phase 1 | Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Vitamin D: up to 2400 mg; oral tablet
Eligibility criteria:
Inclusion Criteria:

3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (XRT) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).

3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.

3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.

3.1.5 Participants will have a life expectancy of at least 5 years.

3.1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.

3.1.7 Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use > 5 mg/day prednisone or equivalent, teriparatide).

3.2.2 Use of any investigational drug within past 90 days.

3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD < -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio >0.20) History of renal stones Renal failure with creatinine over 2.0

3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.

3.2.5 Recent history of excessive alcohol or drug use.

3.2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.

3.2.8 This study is designed to study women after completing primary therapy for breast cancer. Survivors of previous cancers and HIV-positive subjects will not be excluded.
Intervention: Voriconazole
Trial phase: Phase 3
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
Age >/= 18 years.
Patients must sign an informed consent.

Exclusion Criteria:

Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole
Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (European Organisation for Research and Treatment of Cancer (EORTC) criteria).
Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT)> 5 times upper limit normal.
Patients receiving any medication that is contraindicated with the use of voriconazole. Voriconazole is contraindicated with the co-administration of the following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h), carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and efavirenz), St. John's Wort.
Patients currently receiving voriconazole for antifungal prophylaxis.
Intervention: Voriconazole
Trial phase: Phase 3
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
Age >/= 18 years.
Patients must sign an informed consent.

Exclusion Criteria:

Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole
Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (European Organisation for Research and Treatment of Cancer (EORTC) criteria).
Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT)> 5 times upper limit normal.
Patients receiving any medication that is contraindicated with the use of voriconazole. Voriconazole is contraindicated with the co-administration of the following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h), carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and efavirenz), St. John's Wort.
Patients currently receiving voriconazole for antifungal prophylaxis.
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
Eligibility criteria:
Inclusion Criteria:

The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia

Exclusion Criteria:

The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
Intervention: Dorzolamide Hydrochloride
Trial phase: Phase 4
SMILES: CCNC1CC(C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Cosopt 1 drop two times daily was administered for 6 weeks.

Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Eligibility criteria:
Inclusion Criteria:

Early OAG, as determined by a comprehensive ophthalmic examination
Greater than or equal to 18 years of age
Either gender
Any race
Both eyes meet eligibility criteria
Cup to disc ratio less than 0.8 determined by fundoscopy and confirmed by disc photos
Visual field parameters in the study eye: Pattern Standard Deviation (PSD) greater than 1.0 dB but less than 6.0 dB
Ability to cooperate for an outpatient study involving at least five visits over a four month study period
Ability to comply with Cosopt treatment regimen

Exclusion Criteria:

Less than or equal to 18 years old
Refusal to be genotyped or sign Informed Consent for Protocol 1991-144
Pregnant or lactating women
Medical conditions of severe pulmonary compromise with asthma or emphysema or cardiac contraindications to beta-blockers
Ocular disease of chronic angle-closure glaucoma, iridocorneal endothelial disease, posterior polymorphous corneal dystrophy, epithelial downgrowth, uveitic glaucoma, or neovascular glaucoma
Ocular surgery for glaucoma, including trabeculectomy, other glaucoma filtration surgery, glaucoma drainage implant, or laser cyclophotocoagulation
Current use of systemic steroids or chemotherapeutic agents that non-selectively inhibit dividing cells
Proliferative diabetic retinopathy, history of panretinal photocoagulation treatment, diabetic macular edema, or history of macular grid laser treatment
History of changing treatment involving the use oral beta-blockers, angiotensin converting enzyme inhibitors, calcium channel blockers, or oral alpha 2-agonists in the prior two months or in the next month (i.e., must be on stable treatment with any of these drugs for at least two months)
Patients taking erectile dysfunction drugs (i.e., Viagra, Cialis, Levitra)

Contradictions:

bronchial asthma or a history of bronchial asthma
severe chronic obstructive pulmonary disease
sinus bradycardia
second or third degree atrioventricular block
overt cardiac failure
cardiogenic shock
hypersensitivity to any component of Cosopt
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 174
Group description: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.

Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
Eligibility criteria:
Inclusion Criteria:

Clinical decision to augment labor
Gestational age > than or equal to 36 weeks
Singleton gestation
Cephalic presentation
Reassuring fetal heart rate tracing
Cervical dilation between 4 and 8 cm
Ruptured membranes with clear amniotic fluid
Intrauterine pressure catheter in place
Less than 200 MVUs in a 10 minute period
5 or fewer contractions in a 10 minute period
English or Spanish speaking patient

Exclusion Criteria:

Non-reassuring fetal heart rate tracing at time of enrollment
Meconium stained amniotic fluid
Previous uterine incision
Maternal fever (defined as greater than 37.9 C)
Known fetal anomalies
Placenta previa or unexplained vaginal bleeding
Estimated fetal weight of 4,500 grams or more
Abnormal maternal bony pelvis
Grandmultiparity