anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pomaglumetad methionil
Trial phase: Phase 2
SMILES: CSCCC(N)C(=O)NC1(C(=O)O)CS(=O)(=O)C2C(C(=O)O)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: 80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of schizophrenia
Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status
Intervention: Olanzapine
Trial phase: Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of schizophrenia
Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status
Intervention: Aripiprazole
Trial phase: Phase 2
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of schizophrenia
Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status
Intervention: Risperidone
Trial phase: Phase 2
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of schizophrenia
Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status
Intervention: Pioglitazone
Trial phase: Phase 4
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
Eligibility criteria:
Inclusion Criteria:

Diabetic patients must be on diet therapy alone or diet plus a sulfonylurea, or diet plus metformin, or diet plus sulfonylurea/metformin and have a HbA1c ≥ 7.0%.

Patients must have the following laboratory values:

Hematocrit ≥ 34 vol% Serum creatinine ≤ 1.8 mg/dl AST (SGOT) ≤ 2 times upper limit of normal ALT (SGPT) ≤ 2 times upper limit of normal Alkaline phosphatase ≤ 2 times upper limit of normal

Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
Body weight must be stable (± 3-4 pounds) over the three months prior to study
The normal healthy control group will be age, weight (BMI), and gender matched with the diabetic group and must have a normal OGTT according to ADA criteria.
Subjects with IFG/IGT will have a FPG (100-125mg/dl) and/or 2-h plasma glucose (140-199mg/dl) according to ADA criteria.

Exclusion Criteria:

Patients must not have type 1 diabetes.
Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c > 10.0%.
Patients must not have received a thiazolidinedione or insulin for more than one week during the year prior to randomization.
Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2.
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Exenatide: 15 subjects will be randomized to receive Exenatide
Eligibility criteria:
Inclusion Criteria:

Diabetic patients must be on diet therapy alone or diet plus a sulfonylurea, or diet plus metformin, or diet plus sulfonylurea/metformin and have a HbA1c ≥ 7.0%.

Patients must have the following laboratory values:

Hematocrit ≥ 34 vol% Serum creatinine ≤ 1.8 mg/dl AST (SGOT) ≤ 2 times upper limit of normal ALT (SGPT) ≤ 2 times upper limit of normal Alkaline phosphatase ≤ 2 times upper limit of normal

Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
Body weight must be stable (± 3-4 pounds) over the three months prior to study
The normal healthy control group will be age, weight (BMI), and gender matched with the diabetic group and must have a normal OGTT according to ADA criteria.
Subjects with IFG/IGT will have a FPG (100-125mg/dl) and/or 2-h plasma glucose (140-199mg/dl) according to ADA criteria.

Exclusion Criteria:

Patients must not have type 1 diabetes.
Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c > 10.0%.
Patients must not have received a thiazolidinedione or insulin for more than one week during the year prior to randomization.
Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2.
Intervention: Mefloquine
Trial phase: Phase 1
ATC code: P01BC02 | P01BF02
SMILES: OC(c1cc(C(F)(F)F)nc2c(C(F)(F)F)cccc12)C1CCCCN1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 49
Group description: Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
Eligibility criteria:
Inclusion Criteria:

Age: 18-55 years.
A Body mass Index (BMI) of 18 to 28 kg/m
Good physical and mental health status determined on the basis of the medical history and a general clinical examination
Electrocardiogram and clinical laboratory tests interpreted as "normal"
QuantiFERON-TB test negative
female subjects: medically accepted method of contraception

Exclusion Criteria:

prohibited concomitant medication
administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
history of significant disease, allergies
history of drug and/or alcohol abuse
hepatic enzyme inducing drug within 2 months before study drug administration
any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
known to be intolerant to PEG
previously received certolizumab pegol
previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
history of tuberculosis
have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive
Intervention: Mefloquine
Trial phase: Phase 1
ATC code: P01BC02 | P01BF02
SMILES: OC(c1cc(C(F)(F)F)nc2c(C(F)(F)F)cccc12)C1CCCCN1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 49
Group description: Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
Eligibility criteria:
Inclusion Criteria:

Age: 18-55 years.
A Body mass Index (BMI) of 18 to 28 kg/m
Good physical and mental health status determined on the basis of the medical history and a general clinical examination
Electrocardiogram and clinical laboratory tests interpreted as "normal"
QuantiFERON-TB test negative
female subjects: medically accepted method of contraception

Exclusion Criteria:

prohibited concomitant medication
administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
history of significant disease, allergies
history of drug and/or alcohol abuse
hepatic enzyme inducing drug within 2 months before study drug administration
any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
known to be intolerant to PEG
previously received certolizumab pegol
previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
history of tuberculosis
have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1718
Group description: Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
Eligibility criteria:
Inclusion Criteria:

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure

Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:

Smoking history of at least 10 pack years, both current and ex-smokers are eligible
A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria:

Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Males and females at least 18 years of age.
Evidence of nonalcoholic steatohepatitis (NASH) on a liver biopsy performed within six months of entry to this study.

Laboratory parameters indicative of decompensated liver disease including:

bilirubin less than 2 milligrams/decilitre (mg/dl).
stable albumin within normal limits.
prothrombin time less than 3 seconds prolonged.
Serum creatinine less than 1.5 times the upper limit of normal.
Diabetic patients must be stable on oral medication for diabetes or have had less than a 10 percent change in their insulin dose over the past two months.
Thyroid stimulating hormone (TSH) or Free Thyroxine Index (FTI) within the normal range.
Hepatitis C antibody negative.
Hepatitis B Surface Antigen (HBsAg) seronegative.
Antinuclear antibody (ANA) less than 1:320.
Patient provides written informed consent.

Exclusion Criteria:

Alcohol use exceeding 10 to 29 grams per day during the past six months.
Evidence of a cause of liver disease other than nonalcoholic steatohepatitis (NASH) on liver biopsy including: viral hepatitis, alcoholic liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or recent hepatoxic drug exposure.
Patients with cirrhosis.
Use of medications commonly associated with nonalcoholic steatohepatitis (NASH) including: glucocorticoids, estrogens, tamoxifen, methotrexate, nifedipine, diltiazem, chloroquine, isoniazid, or amiodarone within the past six months.
Use of non-steroidal antiinflammatory drugs, fibrates (fenofibrate or gemfibrozil) or warfarin within one month of entering the study.
Uncontrolled diabetes, defined as a glycated hemoglobin (A1C) level greater than 8%.
Patients with insulin-dependent diabetes.
History of jejunal-ileal bypass or extensive small bowel resection.
Substance abuse including, but not limited to, alcohol or intravenous and inhaled drugs within the past six months.
Use of chemotherapy within six months of enrollment.
Patients taking metformin.
Thyroid abnormality in which normal thyroid function cannot be maintained by medication.
Pregnancy, females who are breastfeeding.
Solid organ transplant recipient.
History of a medical condition, which could interfere with participation in and completion of the protocol.
Use of oral supplements of Vitamin E within one month of enrollment.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Placebo (saline) injections into 6 sites in the calf muscle
Eligibility criteria:
Inclusion Criteria:

Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
Ambulatory

Exclusion Criteria:

Active infection in the involved foot
Previous botulinum toxin injections
Ulcers on the dorsal surface of the foot
Ankle-brachial index <0.45
History of cerebral vascular accident or other neurological problems complicating their rehabilitation
Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
Current drug therapy that includes an anticoagulant
History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
Intervention: Oxaliplatin
Trial phase: Not Applicable
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin

Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed diagnosis of colorectal cancer.
ECOG Performance Status 0-2 (Appendix A).
Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.
Consent to donate 4 tubes of PBMC of 7 ml of blood each.
Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).

Adequate organ function as defined as:

Neutrophil count > 1500/μl
Platelets > 75,000/ μl
Hemoglobin > 8 g/dl
Bilirubin < 2.0 X upper limit of normal
Creatinine < 2 mg% or calculated clearance > 40 ml/mt
The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB

Exclusion Criteria:

No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.
Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.
Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).
Patients with grade 2 neuropathy will not be eligible for the study.
The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.