anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Paliperidone
Trial phase: Phase 3
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 294
Group description: Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Eligibility criteria:
Inclusion Criteria:

Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia
Must be experiencing an acute schizophrenic episode with a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 70 at Baseline
Must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
Female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at Screening
Participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

Pregnant or breast-feeding female participants
First antipsychotic treatment ever
Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
Known hypersensitivity to paliperidone extended-release (ER) or risperidone
Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the Investigator) and participants with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria
Intervention: Carvedilol
Trial phase: Not Applicable
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: To be compared to sugar pill

carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
Eligibility criteria:
Inclusion Criteria:

Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates.
Current cocaine use with self-reported use of cocaine > 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence
For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders;
current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts;
screening liver function tests (AST or ALT) greater than 3 times normal;
known allergy or intolerance for carvedilol or methadone.
Intervention: Carvedilol
Trial phase: Not Applicable
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: To be compared to sugar pill

carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
Eligibility criteria:
Inclusion Criteria:

Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates.
Current cocaine use with self-reported use of cocaine > 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence
For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders;
current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts;
screening liver function tests (AST or ALT) greater than 3 times normal;
known allergy or intolerance for carvedilol or methadone.
Intervention: Ospemifene
Trial phase: Phase 3
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 364
Group description: Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Naturally or surgically menopausal
Intact uterus
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal Pap smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Intervention: Gianvi
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.CC12CCC(=O)C=C1C1CC1C1C2CCC2(C)C1C1CC1C21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1406
Group description: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Eligibility criteria:
Inclusion Criteria:

- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Intervention: Gianvi
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.CC12CCC(=O)C=C1C1CC1C1C2CCC2(C)C1C1CC1C21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 232
Group description: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
Eligibility criteria:
Inclusion Criteria:

- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Intervention: Gianvi
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.CC12CCC(=O)C=C1C1CC1C1C2CCC2(C)C1C1CC1C21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 226
Group description: 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Eligibility criteria:
Inclusion Criteria:

- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Intervention: Varenicline
Trial phase: Not Applicable
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Varenicline 2 mg per day.
Eligibility criteria:
Inclusion Criteria:

Males and females between 18 and 55 years old will be eligible for this study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
Subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for opioid dependence.
Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days.
Subjects must meet DSM-IV criteria for cocaine dependence or abuse, and have laboratory confirmation of recent cocaine use (positive urine for cocaine) during the month prior to study entry.
Subjects must be treatment-seekers for opioid and cocaine use.
Subjects must have smoked at least 10 cigarette per day for at least one year. Varenicline's safety has only been studied in smokers.

Exclusion Criteria:

History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
History of severe renal or hepatic diseases.
History of psychosis, schizophrenia, bipolar or major depressive disorder.
History of seizure disorder.
Current diagnosis of alcohol, benzodiazepine and other drug abuse or dependence (other than opiates, cocaine, and nicotine).
Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
Liver function tests (ALT or AST) greater than 3 times normal.
Known allergy to varenicline or methadone.
Intervention: Rosiglitazone
Trial phase: Phase 4
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Rosiglitazone: 8mg tablet once a day for 14 days
Eligibility criteria:
Inclusion Criteria:

Capable of giving informed consent
Agrees to use a barrier method of birth control for the duration of the study

Exclusion Criteria:

History of inflammatory bowel disease
Has taken prescription or over the counter medications in the two weeks prior to enrollment
History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS
Fasting LDL >160 mg/dl
History of smoking in the year prior to enrollment
Pregnant or breastfeeding
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Inhaled Nitric Oxide administered at 80ppm
Eligibility criteria:
Inclusion Criteria:

Acute myocardial infarction and electrocardiographic evidence of ST elevation
No clinical evidence of congestive heart failure
All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
Greater than 18 years of age
Signed Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

Prior myocardial infarction
Requirement for urgent cardiac surgery
Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
Left bundle branch block
Heart block that is expected to require a temporary pacemaker for greater than 72 hours
Prior use of thrombolytic therapy for the current event
Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (BSA)
Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion within 6 weeks prior to presentation, or hemorrhagic stroke within the 6 weeks prior
Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
Known or suspected aortic dissection.
Prior history of pulmonary disease requiring chronic oxygen therapy.
Pregnancy, lactating, and women of childbearing potential.
Medical problem likely to preclude completion of the study.
Use of investigational drugs or device within the 30 days prior to enrollment
Intervention: Sodium Thiosulfate
Trial phase: Not Applicable
SMILES: O=S([O-])([O-])=S.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient with thrice weekly treatments
Coronary artery calcium score greater than 50
Age greater than 18
Compliant with hemodialysis treatments
Informed consent

Exclusion Criteria:

Allergy to sodium thiosulfate
Pregnancy
Incarceration
Enrollment in another study
Life expectancy less than 5 months
Expectation of recovery of renal function
Urine output of greater than 200 ml/day or contrast allergy will not receive intravenous contrast
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: 2
Group description: Previously chemotherapy treated cohorts: Temozolomide (TMZ)
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic melanoma

Stage IV disease
Progressive disease
No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mL
Platelet count ≥ 100,000/mL
Hemoglobin ≥ 9 g/dL
Creatinine ≤ 2.5 x upper limit of normal (ULN)
AST ≤ 3 x ULN
Alkaline phosphatase ≤ 3.0 x ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after completion of study therapy

No uncontrolled intercurrent illness including, but not limited to, any of the following:

Active infection
NYHA class III or IV congestive heart failure
No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
At least 4 weeks since prior radiotherapy

At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)

No prior chemotherapy treatment with agents similar to study drugs
No prior chemotherapy in the metastatic setting (for chemo-naive patients)
No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
No other concurrent investigational agents
No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy
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: 9
Group description: Chemotherapy-naive cohorts: Temozolomide (TMZ)
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic melanoma

Stage IV disease
Progressive disease
No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mL
Platelet count ≥ 100,000/mL
Hemoglobin ≥ 9 g/dL
Creatinine ≤ 2.5 x upper limit of normal (ULN)
AST ≤ 3 x ULN
Alkaline phosphatase ≤ 3.0 x ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after completion of study therapy

No uncontrolled intercurrent illness including, but not limited to, any of the following:

Active infection
NYHA class III or IV congestive heart failure
No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
At least 4 weeks since prior radiotherapy

At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)

No prior chemotherapy treatment with agents similar to study drugs
No prior chemotherapy in the metastatic setting (for chemo-naive patients)
No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
No other concurrent investigational agents
No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy
Intervention: Hydroxyurea
Trial phase: Phase 1 | Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 29
Group description: Hydroxyurea
Eligibility criteria:
Inclusion Criteria:1. Laboratory confirmation of a homozygous deletion or mutation of the SMN1 gene 2. Clinical Diagnosis of Type I SMA (never achieved independent sitting) 3. Onset of disease before the age of 6 months 4. Enrollment in study within 6 months of diagnosis Exclusion Criteria:1. Known hematological disorders, such as chronic anemia (defined as platelet count less than 100,000/mm^3) in two contiguous measures in two weeks 2. Severe systemic disorders such as congenital heart disease, other major birth defects involving internal organs, or severe birth asphyxia 3. Participation in SMA clinical trials for other experimental drugs 4. Requiring continuous respiratory support before the initiation of HU treatment
Intervention: Hydroxyurea
Trial phase: Phase 1 | Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 27
Group description: Hydroxyurea
Eligibility criteria:
Inclusion Criteria:1. Laboratory confirmation of a homozygous deletion or mutation of the SMN1 gene 2. (Type II) Can sit independently but cannot walk without support by the age of 16 months and never achieve independent walking thereafter; OR (Type III) Can walk independently within the first 2 years of life, but showing rapid progression of weakness resulting in the loss of independent ambulation by 6 years of age 3. Patient is older than 16 months and younger than 8 years old at the time of enrollment

Exclusion Criteria:1. Known hematological disorders, other systemic disorders, or severe birth asphyxia 2. Participation in SMA clinical trials for other experimental drugs 3. Requiring continuous respiratory support before the initiation of HU treatment
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 123
Group description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female asthmatic children with mild to moderate persistent asthma.
12 months to 8 years of age.
For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
AND with at least one major or two minor risk factors.

Exclusion Criteria:

Any other significant childhood illness/abnormality or chronic lung disease
Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 123
Group description: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female asthmatic children with mild to moderate persistent asthma.
12 months to 8 years of age.
For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
AND with at least one major or two minor risk factors.

Exclusion Criteria:

Any other significant childhood illness/abnormality or chronic lung disease
Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.