anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Varenicline
Trial phase: Not Applicable
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 163
Group description: For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
Eligibility criteria:
Inclusion Criteria:

18-60 years of age
Smoke at least 15 cigarettes daily
Expired-air carbon monoxide (CO) > 10 ppm
Medically eligible to receive Varenicline.

Exclusion Criteria:

Patients who are pregnant or lactating
Who show evidence of renal dysfunction (BUN > 25 mg/dL, or creatinine > 1.3 mg/dL)
Are using other smoking cessation medications
Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: patients treated with 1 ml of s.c. saline solution
Eligibility criteria:
Inclusion Criteria:

Males or females > 16 and < 80 years of age.
Blood pressure < 140/90 mmHg.
Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.
Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

Exclusion Criteria:

Biopsy of transplant kidney
Poorly controlled hypertension
Single kidney
Renal cancer
Hydro/pyonephrosis
Renal size significantly reduced
Severe obesity
Coagulation disorder
Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min
Intervention: Desmopressin
Trial phase: Phase 4
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Eligibility criteria:
Inclusion Criteria:

Males or females > 16 and < 80 years of age.
Blood pressure < 140/90 mmHg.
Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.
Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

Exclusion Criteria:

Biopsy of transplant kidney
Poorly controlled hypertension
Single kidney
Renal cancer
Hydro/pyonephrosis
Renal size significantly reduced
Severe obesity
Coagulation disorder
Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min
Intervention: (2-{7-[2-(4-Cyano-2-fluoro-phenoxy)-ethyl]-9-oxa-3,7-diaza-bicyclo[3.3.1]non-3-yl}-ethyl)-carbamic acid tert-butyl ester
Trial phase: Phase 2
SMILES: CC(C)(C)OC(=O)NCCN1CC2CN(CCOc3ccc(C#N)cc3F)CC(C1)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Eligibility criteria:
Inclusion Criteria:

Male patients and postmenopausal women
Mildly/moderately decreased heart function
Regular heart rhythm

Exclusion Criteria:

Potassium outside normal reference values
Child bearing potential
Severely decreased heart function
Intervention: Citalopram
Trial phase: Not Applicable
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 99
Group description: The depressed participants in this arm will be given Lexapro.

Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day.

At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded.
Eligibility criteria:
Depressed:

Inclusion Criteria:

Participant meets DSM-IV criteria for major depressive disorder
Minimum score greater than 18 on Hamilton Depression Inventory
Participant is right handed
Participant speaks English

Exclusion Criteria:

Significant limitations that would interfere with testing procedures, such as uncorrected visual or hearing loss
MRI contraindications, such as foreign metallic implants or a pacemaker
Known primary neurological disorders, including dementia, stroke, encephalopathy, Parkinson's disease, brain tumors, multiple sclerosis, or seizure disorder
Severe or unstable medical illness, such as a heart attack within the past 3 months, end stage cancer, or conditions or drugs that may cause depression (like systemic steroids or uncorrected hypothyroidism)
Currently at risk for suicide
Known allergy or hypersensitivity to escitalopram
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
Eligibility criteria:
Inclusion Criteria:

Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
Eligibility criteria:
Inclusion Criteria:

Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
Eligibility criteria:
Inclusion Criteria:

Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
Eligibility criteria:
Inclusion Criteria:

Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
Eligibility criteria:
Inclusion Criteria:

Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Eligibility criteria:
Inclusion Criteria:

Stage III, IV SCCHN
Completed curative treatment

Exclusion Criteria:

Prior chemotherapy or radiotherapy
Recurrent disease
Intervention: Denintuzumab mafodotin
Trial phase: Phase 2
SMILES: CCC(C)C(C(CC(=O)N1CCCC1C(OC)C(C)C(=O)NC(Cc1ccccc1)C(=O)O)OC)N(C)C(=O)C(NC(=O)C(C(C)C)N(C)C(=O)CCCCCN1C(=O)CC(SCC(N)C(=O)O)C1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
Eligibility criteria:
Inclusion Criteria:

Male or female older than 17 years.
Clinical diagnosis of probable multiple system atrophy
Provide written informed consent to participate in the study
Understand that they may withdraw their consent at any time

Exclusion Criteria:

Women who are pregnant or lactating
In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness.
In the investigator's opinion, the subjects are significantly dehydrated, as determined by clinical evaluation including measurement of skin turgor, blood urea nitrogen and creatinine values.
Intervention: Mirtazapine
Trial phase: Phase 3
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 184
Group description: Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Eligibility criteria:
Inclusion Criteria:

Sign written informed consent
Completed clinical trial 21106/P05701/MK-8265-002

Exclusion Criteria:

Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
Pregnancy
Intervention: Succinylcholine
Trial phase: Phase 3
ATC code: M03AB01
SMILES: C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects >=18 years of age;
ASA Class 1-3;
Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;
Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
Subjects who have given written informed consent.

Exclusion Criteria:

Subjects known to have ischemic heart disease or a history of myocardial infarction;
Subjects in whom a difficult intubation is expected because of anatomical malformations;
Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL per min);
Subjects known or suspected to have significant hepatic dysfunction;
Subjects known or suspected to have a (family) history of malignant hyperthermia;
Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
Female subjects who are pregnant;
Female subjects who are breast-feeding;
Subjects who have participated in a previous sugammadex trial;
Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 267
Group description: Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Relapsing multiple sclerosis,
Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
Pregnant or nursing woman,
Alcohol or drug abuse,
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
Human immunodeficiency virus (HIV) positive,
Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Relapsing multiple sclerosis,
Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
Pregnant or nursing woman,
Alcohol or drug abuse,
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
Human immunodeficiency virus (HIV) positive,
Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.