anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Eligibility criteria:
Inclusion Criteria:

Is of American Society of Anesthesiologists (ASA) class 1 - 3;
Is at least 20 years but under 65 years of age;
Japanese participants;
Is scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of neuromuscular blocking agents (NMBAs), with an anticipated duration of about 1.5-3 hours;
Has given written informed consent.

Exclusion Criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Is known or suspected to have neuromuscular disorders impairing the effect of NMBAs and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Is known or suspected to have a (family) history of malignant hyperthermia;
Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Females who were pregnant;
Females not using birth control or using only oral contraception as birth control continuously;
Were breast-feeding;
Has already participated in P05956, or in another trial with sugammadex;
Has participated in another clinical trial within 6 months of entering into P05956
Intervention: Venlafaxine Hydrochloride
Trial phase: Phase 4
SMILES: COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 69
Group description: venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Eligibility criteria:
Inclusion Criteria:

Spinal cord injury (ASIA A-D)
At least one month post injury
Meets DSM IV criteria for major depression or dysthymia on the SCID
At least moderately severe depression (PHQ-9 score >= 10)
Within reasonable travel distance to one of the study sites

Exclusion Criteria:

Current DSM IV alcohol or drug dependence
History of bipolar disorder or psychosis
History of >= 2 suicide attempts or suicide attempt with 5 years
Current suicidal intent or plan
Medical contraindications
Non-English speaker
Clinically significant cognitive/language impairment
History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks
Current use of antidepressant medications (will not exclude if on low dose of a tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for depression, or electroconvulsive therapy
Pregnant or lactating women or women of childbearing potential who are not willing to use a reliable form of contraception
Unstable medical condition, as determined by physical examination, CBC w/ platelets (including hematocrit, hemoglobin, WBC, differential), serum chemistry panel (serum sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), liver transaminases (AST, ALT), thyroid stimulating hormone (TSH), urinalysis, supine diastolic blood pressure (SDBP) > 90 mm Hg, or near terminal illness (primary care physician estimates that patient has < 1 year to live)
Anticipated major surgical procedures within the 12 weeks of randomization
Use of an investigational drug within 30 days
Use of psychoactive medications, including corticosteroids and anticonvulsants, that have not been at a stable dose for at least 2 weeks
Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance (including St. John's Wort) within 7 days of start of double-blind treatment. If the patient is taking a sedative deemed necessary for sleep induction or spasticity, the dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are permitted if at a stable dose for at least 2 weeks.
Refusal to participate
Intervention: Conivaptan
Trial phase: Phase 2
ATC code: C03XA02
SMILES: Cc1nc2c([nH]1)CCN(C(=O)c1ccc(NC(=O)c3ccccc3-c3ccccc3)cc1)c1ccccc1-2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Eligibility criteria:
Inclusion Criteria:

Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Subject has a history of bleeding from esophageal varices within three months before the start of the study
Intervention: Conivaptan
Trial phase: Phase 2
ATC code: C03XA02
SMILES: Cc1nc2c([nH]1)CCN(C(=O)c1ccc(NC(=O)c3ccccc3-c3ccccc3)cc1)c1ccccc1-2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Eligibility criteria:
Inclusion Criteria:

Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Subject has a history of bleeding from esophageal varices within three months before the start of the study
Intervention: Modafinil
Trial phase: Phase 1 | Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: One 100 mg orally administered dose of Armodafini before PET scan.
Eligibility criteria:
Inclusion Criteria:

Signed written informed consent to participate in the study.
Age: 18 - 35
If female, non-pregnant, non-nursing with a negative serum pregnancy test and using an adequate form of birth control.
Supine and standing blood pressure within the range 110/60 to 150/95 mmHg.
Heart rate, after resting for 5 minutes, within the range 46-90 beats/min.
Right-handed.

Exclusion Criteria:

Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism.

Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.

Scores of Baseline Scales:

Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)(Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)(Beck, Ward et al. 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)

Tics or Tourette's Syndrome.
History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
Any clinically significant chronic medical condition, in the judgment of the investigator.
Mental impairment as evidenced by an I.Q. <75.
Exposure to dopamine receptor antagonists within the previous three (3) months.
Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
Subjects receiving psychotropic medication.
Any clinically significant abnormality in the screening laboratory tests, vital signs, or 11-lead ECG, outside of normal limits.
Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: OROS = Osmotic-controlled Release Oral delivery System
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, 12-17 years of age.
ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.
Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.
Each subject and his/her authorized legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents.
Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures.

Exclusion Criteria:

Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Organic brain disorders or mental retardation (I.Q. <75).
Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session.
Severe phobia of being in small, enclosed spaces.
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study.
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Dextromethorphan 0.25 mg/kg per day

Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.

Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial.
Eligibility criteria:
Inclusion Criteria:

those who have classic or atypical RTT with a proven mutation in the MeCP2 gene;
those with documented EEG evidence of spike activity who may or may not have clinical seizures;
subjects must be between 2years -14.99 years of age.

Exclusion Criteria:

those without an established mutation in the MeCP2 gene;
those who do not have EEG evidence of spike activity;
those with mutations in the MeCP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
those on medications that could interact with DM, e.g. monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitor (SSRI), sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the Cytochrome P450 (CYP450) isoform cytochrome P450 2D6 (CYP2D6) (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;
those whose pregnancy test is positive; and,
those showing poor compliance with any aspect of the study;
foster children
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Dextromethorphan 2.5 mg/kg/day

Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.

Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial.
Eligibility criteria:
Inclusion Criteria:

those who have classic or atypical RTT with a proven mutation in the MeCP2 gene;
those with documented EEG evidence of spike activity who may or may not have clinical seizures;
subjects must be between 2years -14.99 years of age.

Exclusion Criteria:

those without an established mutation in the MeCP2 gene;
those who do not have EEG evidence of spike activity;
those with mutations in the MeCP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
those on medications that could interact with DM, e.g. monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitor (SSRI), sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the Cytochrome P450 (CYP450) isoform cytochrome P450 2D6 (CYP2D6) (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;
those whose pregnancy test is positive; and,
those showing poor compliance with any aspect of the study;
foster children
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Dextromethorphan 5mg/kg/day

Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.

Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial.
Eligibility criteria:
Inclusion Criteria:

those who have classic or atypical RTT with a proven mutation in the MeCP2 gene;
those with documented EEG evidence of spike activity who may or may not have clinical seizures;
subjects must be between 2years -14.99 years of age.

Exclusion Criteria:

those without an established mutation in the MeCP2 gene;
those who do not have EEG evidence of spike activity;
those with mutations in the MeCP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
those on medications that could interact with DM, e.g. monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitor (SSRI), sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the Cytochrome P450 (CYP450) isoform cytochrome P450 2D6 (CYP2D6) (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;
those whose pregnancy test is positive; and,
those showing poor compliance with any aspect of the study;
foster children
Intervention: OXYBATE
Trial phase: Phase 2
SMILES: O=C(O)CCCO
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
Eligibility criteria:
Inclusion Criteria:

Patients aged 18-45 with a DSM-IV diagnosis of schizophrenia and insomnia related to schizophrenia, confirmed by a structured interview (SCID).

Exclusion Criteria:

Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team).
Unstable medical illness.
Diagnosis of restless leg syndrome, a seizure disorder, uncontrolled hypertension, unstable cardiac illness, or obstructive sleep apnea.
Pregnancy or lack of adequate birth control.
History of substance dependence disorder.
Current treatment with valproic acid.
Succinic semialdehyde dehydrogenase deficiency (SSADH).
Persistent need for treatment with benzodiazepines, barbiturates, opiates or other sedative hypnotics.
Intervention: Rotigotine
Trial phase: Phase 4
ATC code: N04BC09
SMILES: CCCN(CCc1cccs1)[C@H]1CCc2c(O)cccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Eligibility criteria:
Inclusion Criteria:

Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism.
Subject is scheduled for an operation requiring general anesthesia.

Exclusion Criteria:

Subject has previously been treated with rotigotine.
Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch.
Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that requires magnetic resonance imaging or cardioversion.
Subject has a high probability to require extended postoperative ventilation (> 24 hours).
Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.
Intervention: Semagacestat
Trial phase: Phase 3
SMILES: CC(C)[C@H](O)C(=O)N[C@@H](C)C(=O)N[C@@H]1C(=O)N(C)CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 529
Group description: Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Eligibility criteria:
Inclusion Criteria:

Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 at Visit 1
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed

Exclusion Criteria:

Is not capable of swallowing whole oral medication
Has serious or unstable illnesses
Does not have a reliable caregiver
Chronic alcohol or drug abuse within the past 5 years
Has ever had active vaccination for AD
Intervention: Semagacestat
Trial phase: Phase 3
SMILES: CC(C)[C@H](O)C(=O)N[C@@H](C)C(=O)N[C@@H]1C(=O)N(C)CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Eligibility criteria:
Inclusion Criteria:

Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 at Visit 1
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed

Exclusion Criteria:

Is not capable of swallowing whole oral medication
Has serious or unstable illnesses
Does not have a reliable caregiver
Chronic alcohol or drug abuse within the past 5 years
Has ever had active vaccination for AD
Intervention: Racivir
Trial phase: Phase 4
ATC code: J05AF09 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
Eligibility criteria:
Inclusion Criteria:

HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
Able to understand the study procedures and willing to sign informed consent

Exclusion Criteria:

Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Pregnancy.
Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
Unwillingness to participate in study procedures, including Mental Health referral and intervention.
Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.