anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Melphalan
Trial phase: Phase 2
ATC code: L01AA03
SMILES: N[C@@H](Cc1ccc(N(CCCl)CCCl)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma

- Relapsed disease

Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously

Measurable disease, defined by ≥ 1 of the following:

Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Absolute neutrophil count ≥ 1,000/μL
Platelet count ≥ 75,000/μL
Hemoglobin ≥ 8.0 g/dL
CD4 > 100/μL
Creatinine ≤ 3 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical or breast cancer
No uncontrolled infection
No other co-morbidity that would interfere with patient's ability to participate in trial

PRIOR CONCURRENT THERAPY:

No limit to prior therapy
At least 4 weeks since prior melphalan or other myelosuppressive agents
At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)

No concurrent high-dose corticosteroids

Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent) allowed if they are being given for disorders other than amyloid (e.g., adrenal insufficiency or rheumatoid arthritis)
Concurrent continuation of low level/stable steroid doses for replacement or inhalation therapy allowed
Concurrent bisphosphonates allowed
No concurrent immunosuppressive medications such as cyclosporine
No other concurrent investigational treatment
No concurrent cytotoxic chemotherapy or external-beam radiotherapy>
No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)
Intervention: Tri-sprintec
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.C#CC1(OC(C)=O)CCC2C3CCC4=CC(=NO)CCC4C3CCC21CC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 137
Group description: Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Eligibility criteria:
Inclusion Criteria:

over 18
student enrolled in college or graduate program
Not have used the contraceptive patch or oral contraceptives within the last month
Never have used a contraceptive vaginal ring
Interested in using hormonal contraceptives, specifically NuvaRing and oral contraceptive pills for next 3 months
In general good health
Premenopausal with the ability to menstruate

Exclusion Criteria:

Known or suspected pregnancy
Pregnancy within 2 months of trial medication
Past use of any contraceptive vaginal ring
Hypersensitivity or allergy to NuvaRing or Oral Contraceptives
Use of investigational drug within 2 months of start of trial medication
Use of the contraceptive patch or oral contraceptives within past month
Use of any injectable contraception within 6 months of trial medication
Planning pregnancy in next 6 months
Intervention: Ziprasidone
Trial phase: Phase 2
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 24
Group description: ziprasidone: 20-160 mg/d
Eligibility criteria:
Inclusion Criteria:

Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
clinically referred

Exclusion Criteria:

prolonged corrected QT interval
history of syncope
Intervention: (7r)-14-Cyclohexyl-7-{[2-(Dimethylamino)ethyl](Methyl)amino}-7,8-Dihydro-6h-Indolo[1,2-E][1,5]benzoxazocine-11-Carboxylic Acid
Trial phase: Phase 1
SMILES: CN(C)CCN(C)C1COc2ccccc2-c2c(C3CCCCC3)c3ccc(C(=O)O)cc3n2C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
Eligibility criteria:
Inclusion Criteria:

Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Participant has a clinical diagnosis of chronic HCV infection (for Part II only).

Exclusion Criteria:

Participant has a history of stroke, chronic seizures, or major neurological disorder
Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
Participant has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
Participant has a history of documented Human Immunodeficiency Virus (HIV) infection
Intervention: Montelukast
Trial phase: Phase 1
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Participants receiving Montelukast 0.1 mg inhalation powder
Eligibility criteria:
Inclusion Criteria:

Male or female between the ages of 18 and 65
Must have mild or moderate asthma (Part III only)
Nonsmoker for at least 6 months

Exclusion Criteria:

History of stroke, chronic seizures or major neurological disorder
You are nursing
Drink more than 3 glasses of alcohol a day
Have allergy to or not able to tolerate lactose
Have a history of drug abuse in the last 5 years
Drink more than 6 beverages containing caffeine a day
Have had surgery, donated blood or participated in another investigational study in the last 4 weeks
Intervention: Montelukast
Trial phase: Phase 1
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Participants receiving Montelukast 10 mg inhalation powder
Eligibility criteria:
Inclusion Criteria:

Male or female between the ages of 18 and 65
Must have mild or moderate asthma (Part III only)
Nonsmoker for at least 6 months

Exclusion Criteria:

History of stroke, chronic seizures or major neurological disorder
You are nursing
Drink more than 3 glasses of alcohol a day
Have allergy to or not able to tolerate lactose
Have a history of drug abuse in the last 5 years
Drink more than 6 beverages containing caffeine a day
Have had surgery, donated blood or participated in another investigational study in the last 4 weeks
Intervention: Indacaterol
Trial phase: Phase 2
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects,
40 to 80 years of age,
with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
Subjects who demonstrate a plethysmographic functional residual capacity >120% predicted normal

Exclusion Criteria:

No COPD exacerbations within 6 weeks prior to dosing,
no concomitant lung disease such as asthma,
no requirement for long term oxygen treatment or history of lung reduction surgery.
No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Lansoprazole and dietary control

Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Healthy children with a diagnosis of dysphonia age 3-18 years.
Dysphonia must be present for at least one month duration.
May have vocal cord nodules present.
Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.
Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
Caregiver must be able to read, write, and understand English.
Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.

Exclusion Criteria:

Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy.
Dysphonia must not be due to an acute upper respiratory infection.
Must not have been treated with proton pump inhibitor medication in the past 12 months.
Inability of child to cooperate with recording of voice for analysis.
Inability of caregiver to read, write, and understand English.
Mental retardation, cognitive impairment, or developmental delay.
History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
Intervention: Mifepristone
Trial phase: 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: 141
Group description: Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
Eligibility criteria:
Inclusion Criteria:

Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
Have not been taking excluded medication for at least 7 days prior to randomization
Have a negative pregnancy test
If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed

Exclusion Criteria:

Have any primary psychiatric diagnosis other than psychotic depression.
Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
Have undergone electroconvulsive therapy within 3 months prior to randomization
Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
Are female and are pregnant or lactating
Are currently taking excluded medications
Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others
Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
Have previously participated in a clinical trial of mifepristone
Have a history of an allergic reaction to mifepristone
Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics
Intervention: MEGESTROL ACETATE
Trial phase: Phase 2
ATC code: G03AA04 | G03AB01 | G03AC05 | G03DB02 | G03FA08 | G03FB04 | L02AB01
SMILES: [H][C@@]12C=C(C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Subjects were treated with 575 mg per day as single dose for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Capable of and willing to provide informed consent
Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator)
An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weight for frame size, or a recent history of unintentional weight loss of 10% from the subjects baseline
Weight losses was clinically associated with AIDS-related wasting and not related to any other disease process
Women of childbearing potential had to agree to use effective contraception for the duration of the study and for two weeks after the last dose
Clinical laboratory values had to be within normal limits or out-of-range limits must be designated as not clinically significant (some exceptions per protocol)
Able to read and write in the study related documents translated into the primary local language
Capable of and willing to return to the clinic regularly for study visits
Must have been taking a stable regimen of accepted HIV anti-retroviral treatments for at least two weeks prior to study entry
Capable of completing a 3-day food intake diary with instruction
Willing to abstain from any illegal or recreational drug substances for the duration of the trial
Willing to abstain from taking any other medications or substances known to affect appetite or weight gain (eg, steroids [other than those inhaled for treatment of asthmatic conditions], nutritional supplements [other than vitamins or minerals], dronabinol, recombinant human growth hormone, etc.)

Exclusion Criteria:

Weight loss due to factors other than AIDS-related wasting
Enrollment in any other clinical trial
Lack of access to regular meals
Women of childbearing potential could not be pregnant or nursing
Clinically severe depression evidenced by a baseline score of 17 or more on the Hamilton Depression Rating Scale (GRID-HAMD-17)
Recent evidence of or history of significant psychiatric illness that may have compromised the subject's ability to comply with the study requirements
Intractable or frequent vomiting that regularly interfered with eating
Clinically significant diarrhea that would have interfered with absorption of foods or medications
Clinically significant oral lesions or dental conditions that would have interfered with eating a regular diet
History or evidence of thromboembolic events or any first degree relative with a history of thromboembolic events
Active AIDS-defining illness or other clinically significant or uncontrolled medical problems
Current evidence of or history of diabetes mellitus or hypoadrenalism
Systemic treatment with glucocorticoids within the 12 months prior to study entry
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Memantine 10 mg bid
Eligibility criteria:
Inclusion Criteria:

Multiple sclerosis by McDonald Criteria.
Spasticity. A minimum score of two on the Ashworth spasticity scale in at least one lower extremity muscle group and a total score of at least four in the lower extremity muscles tested.
Age 18-70.
Normal renal function (estimated CrCl > 50 ml/min).
Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods (including barrier methods, IUD, and oral contraceptives) for the duration of the study.
Willing and able to perform all procedures related to the clinical trial and to provide informed consent.

Exclusion Criteria:

Evidence of clinically significant thyroid, gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, neoplastic, endocrine (including diabetes mellitus), neurologic (other than MS), or other medical or psychiatric disorder at screening.
Women must not be pregnant or lactating. Serum or urine pregnancy tests will be required prior to randomization for women of childbearing potential unless the last menstrual period started less than 28 days prior to randomization.
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Eligibility criteria:
Inclusion Criteria:

Patients belonging to ASA class I to II classification who are undergoing abdominal gynecologic surgery will be included in the study.

Exclusion Criteria:

Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer, sepsis, or coagulation problems will be excluded from the study.
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
Eligibility criteria:
Inclusion Criteria:

Diagnosis of metastatic breast cancer.
Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
No clinical sign of brain progression.
At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Life expectancy ≥3 months.
Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
Serum creatine <1.5 x ULN.
Effective contraception if the risk of conception exists.

Exclusion Criteria:

Concurrent chronic systemic immune therapy not indicated in the study protocol.
Any investigational agent(s) within 4 weeks prior to entry.
Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
Known drug abuse/alcohol abuse.
Legal incapacity or limited legal capacity.
Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
Women who are pregnant or breastfeeding.
Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
Intervention: Levemir
Trial phase: Phase 2 | Phase 3
SMILES: CCCCCCCCCCCCCC(=O)NCCCCC(NC(=O)C1CCCN1C(=O)C(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(Cc1ccccc1)NC(=O)C(Cc1ccccc1)NC(=O)CNC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C1CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C2CSSCC(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(NC(=O)CN)C(C)CC)C(C)C)C(=O)NC(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)N1)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)N2)C(C)O)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:

No hospital admission for six weeks or more before the study
No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids).

Exclusion Criteria:

Use of oral or intravenous corticosteroid medications within six weeks of the study.
Evidence of clinically significant liver disease.
Colonization with Burkholderia cepacia.
Colonization with Aspergillus.
Pregnancy.
Medically unstable (stability defined above).