anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Loxapine
Trial phase: Phase 3
ATC code: N05AH01
SMILES: CN1CCN(C2=Nc3ccccc3Oc3ccc(Cl)cc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Eligibility criteria:
Inclusion Criteria:

Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

Agitation caused primarily by acute intoxication
History of drug or alcohol dependence
Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Intervention: Ademetionine
Trial phase: Phase 2 | Phase 3
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
Eligibility criteria:
Inclusion Criteria:

Is at least 18 years of age;
Has smoked more than 10 cigarettes/day for ≥6 months;
Is willing to make a quit attempt;
Is able to participate fully in all aspects of the study;
Has been provided with, understand, and have signed the informed consent.
Is in good health as determined by the physician investigator.

Exclusion Criteria:

Is clinically significant levels of current depression as assessed by CESD (Score >16) and determined by the physician; or have a life-time diagnosis of bipolar disorder, schizophrenia or dementia as determined by physician investigator;
Has an unstable medical condition.
Is using other tobacco product and the primary use is NOT cigarettes.
Is currently (within the past 30-days) using antipsychotics or antidepressants;
Is currently (within the past 30-days) using any treatments for tobacco dependence (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline);
Is currently using another investigational drug at the time of study enrollment;
Is currently (within the past 30 days) using an herbal product or dietary supplement for tobacco abstinence;
Has recent history (in the past 3-months) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators;
Has a recent history of drug abuse as assessed by physician interview;
Is pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence;
Is a history of any major cardiovascular events in the past 3-months including unstable angina, acute MI or coronary angioplasty;
Has clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease;
Is currently on medications interacting with SAMe, including but not limited to, antidepressants, MAO inhibitors, levodopa, meperidine, dextromethorphan, pentazocine and tramadol;
Has another household member or relative participating in the study;
Has known allergy to SAMe.
Intervention: Ademetionine
Trial phase: Phase 2 | Phase 3
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
Eligibility criteria:
Inclusion Criteria:

Is at least 18 years of age;
Has smoked more than 10 cigarettes/day for ≥6 months;
Is willing to make a quit attempt;
Is able to participate fully in all aspects of the study;
Has been provided with, understand, and have signed the informed consent.
Is in good health as determined by the physician investigator.

Exclusion Criteria:

Is clinically significant levels of current depression as assessed by CESD (Score >16) and determined by the physician; or have a life-time diagnosis of bipolar disorder, schizophrenia or dementia as determined by physician investigator;
Has an unstable medical condition.
Is using other tobacco product and the primary use is NOT cigarettes.
Is currently (within the past 30-days) using antipsychotics or antidepressants;
Is currently (within the past 30-days) using any treatments for tobacco dependence (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline);
Is currently using another investigational drug at the time of study enrollment;
Is currently (within the past 30 days) using an herbal product or dietary supplement for tobacco abstinence;
Has recent history (in the past 3-months) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators;
Has a recent history of drug abuse as assessed by physician interview;
Is pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence;
Is a history of any major cardiovascular events in the past 3-months including unstable angina, acute MI or coronary angioplasty;
Has clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease;
Is currently on medications interacting with SAMe, including but not limited to, antidepressants, MAO inhibitors, levodopa, meperidine, dextromethorphan, pentazocine and tramadol;
Has another household member or relative participating in the study;
Has known allergy to SAMe.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)

Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr

Patients are randomized to TXA or saline. This group is the TXA group.
Eligibility criteria:
Inclusion Criteria:

The inclusion of the patients will depend on the following criteria:

All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
Patients will be between the ages of 6 months and 18 years old.
They will be > than 5 kg.
All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification.

Exclusion Criteria:

Patients that will be excluded from the study include the following:

Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
History of thrombotic episodes in the patient
Renal failure or hepatic failure.
Infants less than 5 kg
Age < 6 months or > 18 years old
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Saline

saline: Placebo
Eligibility criteria:
Inclusion Criteria:

The inclusion of the patients will depend on the following criteria:

All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
Patients will be between the ages of 6 months and 18 years old.
They will be > than 5 kg.
All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification.

Exclusion Criteria:

Patients that will be excluded from the study include the following:

Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
History of thrombotic episodes in the patient
Renal failure or hepatic failure.
Infants less than 5 kg
Age < 6 months or > 18 years old
Intervention: Terconazole
Trial phase: Phase 3
ATC code: G01AG02
SMILES: CC(C)N1CCN(c2ccc(OC[C@@H]3CO[C@@](Cn4cncn4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
Eligibility criteria:
Inclusion Criteria:

Female Subjects 18-45 years of age who have achieved spontaneous menarche.
A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control.
A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined.
Maximum of 5 nodules.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

Exclusion Criteria:

Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
Use of oral antibiotics within 30 days.
Use of systemic corticosteroids within 4 weeks.
Use of oral contraceptives within 12 weeks.
Use of isotretinoin in past six months.
Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week.
Use of tanning booths or lamps within 1 week prior to baseline.
BMI >30
History of renal insufficiency
History of hepatic dysfunction
History of adrenal Insufficiency
History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
History of hypertension
Diabetes mellitus with vascular involvement
Migraine headaches with focal neurological symptoms
Recent major surgery with prolonged immobilization
Known or suspected carcinoma of the breast
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Liver tumor (benign or malignant) or active liver disease
Smoking > ½ pack of cigarettes/week
Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II receptor antagonists, heparin and aldosterone antagonists.
Hypersensitivity to any component of the study drug
Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Subjects who are known to be pregnant or planning a pregnancy.
Intervention: Gianvi
Trial phase: Phase 2
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.CC12CCC(=O)C=C1C1CC1C1C2CCC2(C)C1C1CC1C21CCC(=O)O1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Eligibility criteria:
INCLUSION CRITERIA

Female Subjects 14-45 years of age who have achieved spontaneous menarche.
Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley scale.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

EXCLUSION CRITERIA

Change is use of oral or topical antibiotics in past 90 days.
Use of intralesional steroids within 30 days.
Use of isotretinoin in past six months.
Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the past 3 months or 5 half lives (whichever is shorter).
History of renal insufficiency
History of hepatic dysfunction
History of adrenal Insufficiency
History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
History of hypertension
History of Diabetes mellitus with vascular involvement
Migraine headaches with focal neurological symptoms
Major surgery with prolonged immobilization
Known or suspected carcinoma of the breast
History of Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
History of Liver tumor (benign or malignant) or active liver disease
Smokers
Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II receptor antagonists, heparin and aldosterone antagonists.
Hypersensitivity to any component of the study drug
Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Subjects who are known to be pregnant or planning a pregnancy.
Intervention: Risperidone
Trial phase: Not Applicable
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: Female
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Kabuki Syndrome
Medication Naive
Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

Inability to wear actigraphy device
Intervention: Atenolol
Trial phase: Phase 3
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Atenolol: Atenolol 50mg PO QD
Eligibility criteria:
Inclusion Criteria:

Age greater than 25 years
Clinical Marfan Syndrome

Exclusion Criteria:

Previous aortic or cardiac surgery
Pregnancy
Renal Insufficiency
Medication intolerance
Intervention: Losartan
Trial phase: Phase 3
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Losartan: Losartan 100mg PO QD
Eligibility criteria:
Inclusion Criteria:

Age greater than 25 years
Clinical Marfan Syndrome

Exclusion Criteria:

Previous aortic or cardiac surgery
Pregnancy
Renal Insufficiency
Medication intolerance
Intervention: Clofarabine
Trial phase: Phase 2
ATC code: L01BB06
SMILES: [H][C@]1(F)[C@H](O)[C@@H](CO)O[C@H]1n1cnc2c(N)nc(Cl)nc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days

Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.
Eligibility criteria:
Inclusion Criteria:

Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

Adequate hepatobiliary function as indicated by the following laboratory values:

SGOT/SGPT <=2.5 x upper limit of normal
Alkaline phosphatase <=2.5 x upper limit of normal
Serum bilirubin < 1.5 mg/dl
Adequate renal function as indicated by the following laboratory values:
Creatinine Clearance >50 ml/min
Age >/=18 years
Zebroid performance status </= 2 (See Appendix A)
Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
No evidence of chronic active hepatitis or cirrhosis.
HIV-negative
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.

Exclusion Criteria:

Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Pregnant or lactating patients.
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 315
Group description: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Eligibility criteria:
Inclusion Criteria:

Confirmed IBS diagnosis per Rome II criteria for diagnosis of IBS.
Colonoscopy within 2 years as part of IBS diagnostic evaluation.
Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

Symptoms of constipation.
History of other gastrointestinal diseases.
Type 1 or 2 diabetes.
Lactose intolerance not controlled by lactose-free diet.
Intervention: Mifepristone
Trial phase: Phase 2 | Phase 3
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients will be randomized to mifepristone
Eligibility criteria:
Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder. Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.
Intervention: Ambrisentan
Trial phase: Not Applicable
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Ambrisentan

Ambrisentan
Eligibility criteria:
Inclusion Criteria:

Diagnosis of limited or diffuse systemic sclerosis (SSc) according to American College of Rheumatology or LeRoy criteria
Age greater than 18 years of age
At least one digital ulcer located on the volar or lateral surface at or distal to the proximal interphalangeal joints
At least one new DU that developed within 12 weeks prior to screening
Vasodilator therapies, including calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, nitroglycerin, and angiotensin receptor blockers, are permitted as long as the doses are stable for 2 weeks prior to screening and throughout the study
Treatment with omeprazole or other proton pump inhibitors must be stable for 2 weeks prior to screening and throughout the study

Exclusion Criteria:

Patients with pulmonary arterial hypertension, NYHA Class III or IV
Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary failure
Concurrent malignancy except non-melanoma skin cancers
Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of screening
Patients receiving phosphodiesterase-5 inhibitors, endothelin receptor antagonists, or prostanoids within 4 weeks of screening
Patients receiving cyclosporine within 6 weeks of screening
Patients who have participated in any investigational study within 30 days of screening
Pregnant or nursing women
Patients with a history of drug or alcohol abuse within 6 months of screening
History of hepatitis B, hepatitis C, or HIV infection
Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
Inability to comply with study and follow-up procedures
Transaminase elevation > 3X the upper limit of normal at screening
Hemoglobin less than 8.5 g/dL
Platelet count less than 100 X 109/L
White blood cell count less than 3.0 X 109/L
Serum creatinine less than 2.0 mg/dL