anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tadalafil
Trial phase: Phase 2 | Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 40 mg daily
Eligibility criteria:
Inclusion Criteria:

Biopsy proven sarcoidosis
Mean pulmonary artery pressure > 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
Pulmonary capillary wedge pressure ≤ 15 mmHg
PVR values ≥ 3.0 Woods units
Forced vital capacity (FVC) > 40% predicted
Forced expiratory volume in 1 second (FEV1) > 40% predicted
WHO functional class II or III
Stable sarcoidosis treatment regimen for three months prior to entry into study
6 minute walk distance between 150-450 meters
Stable dose of antihypertensive medications
On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study
Non-pregnant females

Exclusion Criteria:

Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
Severe systemic hypertension > 170/95
Severe systemic hypotension < 90/50
History of priapism
Patients with congestive heart failure (left ventricular dysfunction) LVEF < 45% by echocardiogram
Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli)
Use within 1 month of an sildenafil or vardenafil
WHO functional class IV status
Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
Subjects with liver function abnormalities (ALT or AST > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
Advanced kidney failure (GFR < 30 ml/min at screening or at baseline)
History of hypersensitivity reaction or adverse effect related to tadalafil
Pregnant or lactating women
Concomitant use of nitrates (any form) either regularly or intermittently
Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 124
Group description: This group will receive Oxycodone with Acetaminophen orally
Eligibility criteria:
Inclusion Criteria:

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion Criteria:

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Intervention: Naropin
Trial phase: Not Applicable
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 124
Group description: This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Eligibility criteria:
Inclusion Criteria:

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion Criteria:

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 104
Group description: 0.5 mg in capsules for oral administration once daily
Eligibility criteria:
Inclusion Criteria:

Patients with relapsing-remitting forms of MS defined by 2005 revised McDonald criteria.
Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months.
Patients with cognitive impairment at screening, defined as at least one test of the Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the normative data.

Exclusion Criteria:

Patients who had already been treated with multiweekly interferon (interferon beta 1b, or beta 1a multiweekly) and had an unsatisfactory response according to the judgment of the investigator.
Patients with hyperactive forms of the MS disease according to the judgment of the investigator.
Patients with an EDSS score higher than 5.
Patients with a prior or current diagnosis of Major Depression according to DSM-IV.
Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Metformin 1000 mg once daily by mouth for 9 months

Metformin: Metformin 1000 mg once daily by mouth for 9 months
Eligibility criteria:
Inclusion Criteria:

A. General inclusion criteria

Ten to 20 years of age.
Pubertal (Tanner stages 2-5, by examination).
Hemoglobin A1c level of > 8.0% in the 6 months prior to enrollment.
All subjects must have access to a computer.

B. Specific inclusion criteria: [Subjects could have either #1, or #2].

Subjects with clinical and biochemical features of T2DM of > 6mo duration who also have positive T1DM antibodies

Clinical features: acanthosis nigricans, BMI >85%
Biochemical: evidence of insulin resistance at diagnosis
fasting insulin >27 uIU/mL(normal range 6-27) at a fasting blood glucose of ≥ 126 mg/dL, or
fasting c-peptide level of > 7.1 ng/mL (normal range 0.9 - 7.1), or
Homeostasis model of insulin resistance of >3.16

Patients with T1DM of > one yr duration with BMI >85%

Presentation with ketoacidosis at diagnosis
C-peptide <0.9 ng/mL (normal range 0.9 - 7.1),or (insulin < 6 uIU/mL) (NR 6-27) at diagnosis (when blood glucose is ≥ 126 mg/dL)
Can be antibody positive or negative
Increased insulin requirement (>2 Units/kg/day)

Exclusion Criteria:

Subjects on weight altering medications, such as orlistat.
Subjects with eating disorder
Subjects on medications other than insulin and or metformin that may affect blood glucose level.
Subjects with abnormal hepatic function tests.
Subjects with nephropathy, defined in this case as an overnight albumin excretion rate of >200 mcg/min using a first morning urine sample collection.
Subjects with recurrent diabetes ketoacidosis (more than 2 episodes in the past 12 months), or recurrent severe hypoglycemia (more than 2 episodes of hypoglycemia with altered level of consciousness, requiring assistance to treat in the past year).
Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
Known or suspected allergy to metformin.
The receipt of any investigational drug within 6 months prior to this trial.
Active malignant neoplasms.
No access to a computer.
Subjects currently taking metformin for clinical purposes are not eligible to be enrolled in this study.
Intervention: Ganaxolone
Trial phase: Phase 2
ATC code: N03AX27
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 59
Group description: active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6 months
Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
Negative urine drug screen for drugs of abuse
Negative urine pregnancy test for females of childbearing potential
Sexually active participants are required to use a medically acceptable form of birth control

Key Exclusion Criteria

Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)
Females who are pregnant or currently breast feeding
Current or past psychotic disorder, bipolar Type I disorder, or dementia
Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
Participants unwilling to comply with the required alcohol prohibition during the trial
Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
Participants with pending litigation related to the traumatic event
Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
Participants receiving psychotherapy without a stable paradigm for at least 3 months
Non-English speaking participants.
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Metformin

Metformin: Oral metformin QD for two weeks, then BID
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed stage I-III colorectal or breast cancer
Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment
Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.
Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.
Less than 120 minutes of exercise per week
Approval by oncologist or surgeon
English speaking and able to read English
No planned surgery anticipated in the 3 month intervention period
At least one month from any major surgery to start of intervention including colostomy reversal

Exclusion Criteria:

Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)
Metastatic disease
Scheduled to receive any form of further adjuvant cancer therapy
Currently on medication for diabetes treatment
Pregnant or breast-feeding
Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Known hypersensitivity or intolerance to metformin
Intervention: Methotrexate
Trial phase: Phase 3
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Intravenous bolus injection of Methotrexate Starting dose 40 milligram per square meter mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
Eligibility criteria:
Inclusion criteria:

Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
Measurable disease according to RECIST
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
Any other than one previous platinum based systemic regimen given for R/M disease
Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
Pregnancy or breast feeding
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Metformin only
Eligibility criteria:
Inclusion Criteria:

Age 40 to 75 years
Male or postmenopausal female
BMI ≥ 30 kg/m2
One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

Congestive heart failure
Renal impairment
History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
Type I diabetes mellitus
Weight loss > 10% in the past 6 months
Recurrent nephrolithiasis
Current treatment for seizure disorder
Hepatic cirrhosis
Current use of study medications
Current use of oral estrogen
History of smoking cessation in the past three months
Current cholestasis or malabsorption syndrome
Planned use of any herbal or over-the-counter supplements for weight loss
History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
Participation in another clinical drug study within four weeks prior to this investigation.
Participation in any other weight loss or rigorous exercise program.
Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Intervention: Topiramate
Trial phase: Phase 2
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Topiramate only
Eligibility criteria:
Inclusion Criteria:

Age 40 to 75 years
Male or postmenopausal female
BMI ≥ 30 kg/m2
One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

Congestive heart failure
Renal impairment
History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
Type I diabetes mellitus
Weight loss > 10% in the past 6 months
Recurrent nephrolithiasis
Current treatment for seizure disorder
Hepatic cirrhosis
Current use of study medications
Current use of oral estrogen
History of smoking cessation in the past three months
Current cholestasis or malabsorption syndrome
Planned use of any herbal or over-the-counter supplements for weight loss
History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
Participation in another clinical drug study within four weeks prior to this investigation.
Participation in any other weight loss or rigorous exercise program.
Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Intervention: Morphine sulfate pentahydrate
Trial phase: Not Applicable
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: This group will receive 3mg of preservative free morphine epidurally during the procedure.

Preservative free morphine: 3mg given epidurally during the Cesarean section.
Eligibility criteria:
Inclusion Criteria:

Patients having an elective Cesarean section
Healthy women (ASA I or II)
Regional anesthesia candidates

Exclusion Criteria:

Morbid obesity (BMI>40)
Sleep apnea
Age under 18
Intolerance or addiction to opioids
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.

Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
Eligibility criteria:
Inclusion Criteria:

Patients having an elective Cesarean section
Healthy women (ASA I or II)
Regional anesthesia candidates

Exclusion Criteria:

Morbid obesity (BMI>40)
Sleep apnea
Age under 18
Intolerance or addiction to opioids
Intervention: Cabazitaxel
Trial phase: Phase 2
ATC code: L01CD04
SMILES: [H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity

jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Eligibility criteria:
Inclusion Criteria:

Patients are required to have histologically or pathologically confirmed metastatic gastric or esophageal adenocarcinoma.
Patients must demonstrate relapse or progression after at least one prior line of chemotherapy for metastatic disease.
Patients must have measurable disease by CT scan or MRI
Absolute neutrophil count ≥ 1,500/uL, platelet ≥ 100,000/uL and Hgb > 8.0 g/dl.
Total bilirubin ≤ upper institutional limit of normal (ULN), and AST or ALT ≤ 3x ULN; if liver metastases then AST or ALT < 5x ULN
Peripheral neuropathy must be ≤ Grade 1
Creatinine < 2 x ULN
ECOG performance status 0 to 2
Minimum life expectancy of 12 weeks.
Age older than 18 years.
Voluntary, signed written informed consent.
Women of childbearing potential must have a negative pregnancy test Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

History of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
Patients with known, untreated brain metastasis
Any uncontrolled severe, intercurrent illness.
Women who are breast-feeding.
Patients who have undergone major surgery, chemotherapy, or radiotherapy within the last 3 weeks.
Patients on concurrent anticancer therapy