anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CO-TRIMOXAZOLE
Trial phase: Phase 4
ATC code: J01EE01
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC.Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, age >18 years, of all racial and ethnic origins.
We are recruiting 12 normal or underweight (BMI <25kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of sulfamethoxazole and trimethoprim on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of sulfamethoxazole and trimethoprim, so that the pregnancy and post-partum state would be a confounding variable.
Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
History of allergies to sulfones, sulfonamides or trimethoprim.
Sulfones, sulfonamides or trimethoprim are contraindicated for any reason.
Volunteers unwilling to comply with study procedures.
Current suspected or documented ear infection, urinary tract infection, bronchitis, traveler's diarrhea, Pneumocystis carinii pneumonia, or any other bacterial infection.
Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
Current use of medications contraindication with sulfamethoxazole/trimethoprim use: Bepridil, Cisapride, Dofetilide, Levomethadyl, Mesoridazine, Pimozide, Terfenadine, and Thioridazine. Other medications will be screened by study investigators to ensure the safety of research participants and maintain the quality of the study.
Intervention: ASCORBIC ACID
Trial phase: Phase 4
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.

Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
Eligibility criteria:
Inclusion Criteria:

Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.

Exclusion Criteria:

History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
Eligibility criteria:
Inclusion Criteria:

surgery for unilateral ankle arthrodesis
surgery for open reduction and internal fixation of bi/tri malleolar fracture

Exclusion Criteria:

coagulation abnormalities
history of opioid addiction
current chronic pain therapy with high dsoe opioid
allergy to study medication
failure of the sciatic nerve catheter
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Active ziprasidone administered double-blind.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 years.
If female, nonpregnant/nonlactating
If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)
Currently meets DSM-IV criteria for a major depressive episode, non-psychotic.
Having at least 3 of the following criteria listed for predictors of depressive response to neuroleptics: a family history of bipolar disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression, early age of onset of depression (< age 20), failure to respond to antidepressants, and antidepressant tolerance (initial response followed by later loss of response). Inadequate response to antidepressants is identified as follows: having a score of ≥14 on the 17-item HAMD or a CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single antidepressant (defined as a ≥ 6-week trial of acceptable therapeutic dose [≥ 40 mg of fluoxetine, paroxetine or citalopram, 20 mg of escitalopram, 60 mg of duloxetine, 37.5 mg of paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR, 30 mg of mirtazapine, 300 mg of bupropion, 75 mg of nortriptyline, 20 mg of protriptyline, 100 mg of amitriptyline or imipramine)

Exclusion Criteria:

Bipolar depression
Sensitivity to or failure to respond to ziprasidone by history or ziprasidone use in previous 3 months
Active substance abuse or dependence in the previous 3 month
Psychotic disorders
Serious suicidality as evidenced by score of 3 or greater on suicide item of MADRS
Medically unstable as judged by study investigators
Lack of capacity to provide informed, written, consent to investigators
Previous diagnosed cardiac arrhythmias
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: No
Participants at risk: 23
Group description: Starting dose 75 mg by mouth (PO) daily for 28 day cycle.

Eltrombopag: Starting dose 75 mg by mouth (PO) daily for 28 day cycle
Eligibility criteria:
Inclusion Criteria:

Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Age >/= 18 years
PLT transfusion-dependent, defined as need for transfusion to maintain PLT count >/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of the screening period </=50K/µL, with no individual count >55K/µL
Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
ECOG performance status (PS) </=2
Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5* ULN)
Adequate renal function (serum creatinine Cr </=2.2 mg/dL)
For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered in patients responding to eltrombopag
Able to provide informed consent

Exclusion Criteria:

Concurrent chemotherapy for CLL
Diagnosis of Richter's transformation
Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not controlled with treatment such as corticosteroids or cyclosporine. This would include patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB) due to ongoing hemolysis.
Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
Active infection or significant medical illness as determined by the treating physician
Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions
Intervention: Dexmedetomidine Hydrochloride
Trial phase: Phase 3
SMILES: Cc1cccc(C(C)c2cnc[nH]2)c1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
Eligibility criteria:
Inclusion Criteria:

Admitted to Duke University Neuro Critical Care Unit (NCCU)
Adult (18 years of age or older)
Expected Mechanical Ventilation for >48 hours with sedation
Intraventricular catheter in situ

Exclusion Criteria:

Hypersensitivity to study drugs
Prisoners
Moribund state or death expected within 24 hours
Surgery planned within 24 hours of subject enrollment
Receiving study drug, Precedex, prior to entering study
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Diabetic patients with constipation.
Patient must be on stable oral or subcutaneous hypoglycemic medication for 6 months.

Exclusion Criteria:

Acute infections
Ischemic bowel syndrome
Gastrointestinal obstruction
Intervention: Olanzapine
Trial phase: Not Applicable
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Group receiving olanzapine

Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Anorexia Nervosa
Body Mass Index (BMI) between 14.0 and 18.5 kg/m2
Between 18-75 years old
Patient not pursuing intensive treatment (inpatient or day treatment) for weight restoration if BMI less than 18 kg/m2
serum potassium > 2.5 mEq/L

Exclusion Criteria:

Any medical or psychiatric problem requiring medical or psychiatric attention, significant metabolic disturbance upon psychiatrist presentation, and/or significant co-morbid illnesses that are not likely to benefit from proposed treatments or that need specialized treatments for non-eating disorder symptoms.
Diabetes mellitus
QTc > 480 msec at baseline or increase in QTc of > 35 msec since baseline ECG
Significant hyperlipidemia (cholesterol, triglycerides > 1.5 x upper limit of normal)
Current diagnosis of substance abuse or dependence
Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I)
Presence of movement disorder, tardive dyskinesia
History of seizure disorder
Dementia (subjects over age 55 will be assessed by an MMSE administered by a psychiatrist; those who receive an MMSE score >25 will be excluded)
Allergy to olanzapine
Documented treatment with 10 mg/day olanzapine x 8 weeks or known inability to tolerate olanzapine 10 mg/day
Taking psychotropic (antidepressant, antianxiety, mood stabilizer, antipsychotic) medication within the 4 weeks prior to randomization, other than stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin/Norepinephrine Reuptake Inhibitor (SNRI), or use of benzodiazepine or non-benzodiazepine sleep agents. These permissible medications may be continued during the trial if they have been in use by the patient for a period of > 4 weeks at an unchanged dose without any evidence of consistent weight gain (i.e., > 3 lbs/months)
Taking other medication within the last four weeks prior to randomization, known to affect weight (e.g., steroids)
Participation in a psychotherapeutic intervention associated with consistent weight gain (i.e. > 3 lbs/month). (Subjects may participate in the study if they are receiving stable outpatient psychotherapy for the 4 weeks prior to randomization as long as there have been no changes in therapy intensity and the psychotherapy has not been associated with weight gain > 3 lbs over the previous 4 weeks. Subjects may also participate if they recently received partial weight restoration treatment in an intensive inpatient or day program as long as they can document that they have not consistently gained weight in their current treatment setting for the 4 weeks prior to baseline screening.)
Intervention: Linezolid
Trial phase: Phase 3
ATC code: J01XX08
SMILES: CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 335
Group description: Oral linezolid 600 mg twice daily for 10 days
Eligibility criteria:
Inclusion Criteria:

Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: None Reported
Eligibility criteria:
Inclusion Criteria:

pediatric patients age 2 to 17 years old
have a laceration of 4 cm on the face or 7 cm on the remainder of the body
Require procedural sedation to repair the laceration

Exclusion Criteria:

Patients with abnormal nasal physiology which would not allow for adequate medication delivery
Unable to have a guardian present to consent on their behalf
Allergy to ketamine
Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
Presenting with a head injury associated with possible intracranial hypertension
Pregnancy
Lacerations that require repair from a consult service
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: None report
Eligibility criteria:
Inclusion Criteria:

pediatric patients age 2 to 17 years old
have a laceration of 4 cm on the face or 7 cm on the remainder of the body
Require procedural sedation to repair the laceration

Exclusion Criteria:

Patients with abnormal nasal physiology which would not allow for adequate medication delivery
Unable to have a guardian present to consent on their behalf
Allergy to ketamine
Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
Presenting with a head injury associated with possible intracranial hypertension
Pregnancy
Lacerations that require repair from a consult service
Intervention: Ovral
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
Eligibility criteria:
Inclusion Criteria:

Age 18-35
BMI > 30kg/m2
Proof of a normal breast and pelvic exam within last 9 months
Self reported normal menstrual periods (24-35 days)
Good general health
In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
Single progesterone level during screening visit ≥ 3ng/mL
Hematocrit ≥ 36%

Exclusion Criteria:

Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
Smoker (must smoke 0 cigarettes)
Actively seeking/involved in a weight loss program
Currently pregnant/seeking pregnancy in the next 6 months
Currently breast-feeding
Past or current diagnosis of polycystic ovarian disease
Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: TAP Block utilizing 15mL of 0.9% normal saline per side

0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Eligibility criteria:
Inclusion Criteria:

ASA II-III patient
> 18 years of age who is pregnant
presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2.

Exclusion Criteria:

< 18 years of age
contraindication to placement of a spinal anesthetic
contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs)
patients receiving medical therapies considered to result in tolerance to opioids
patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient
patients with a history of diabetes mellitus
patients undergoing a vertical midline skin incision
patients who are undergoing a cesarean delivery after a failed vaginal trial of labor
patients who had a prior epidural placed for labor analgesia during the same hospital encounter.
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: TAP Block utilizing 15ml of 0.2% ropivacaine per side

0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Eligibility criteria:
Inclusion Criteria:

ASA II-III patient
> 18 years of age who is pregnant
presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2.

Exclusion Criteria:

< 18 years of age
contraindication to placement of a spinal anesthetic
contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs)
patients receiving medical therapies considered to result in tolerance to opioids
patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient
patients with a history of diabetes mellitus
patients undergoing a vertical midline skin incision
patients who are undergoing a cesarean delivery after a failed vaginal trial of labor
patients who had a prior epidural placed for labor analgesia during the same hospital encounter.
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: TAP Block utilizing 15ml of 0.5% ropivacaine per side

0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Eligibility criteria:
Inclusion Criteria:

ASA II-III patient
> 18 years of age who is pregnant
presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2.

Exclusion Criteria:

< 18 years of age
contraindication to placement of a spinal anesthetic
contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs)
patients receiving medical therapies considered to result in tolerance to opioids
patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient
patients with a history of diabetes mellitus
patients undergoing a vertical midline skin incision
patients who are undergoing a cesarean delivery after a failed vaginal trial of labor
patients who had a prior epidural placed for labor analgesia during the same hospital encounter.