anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Eligibility criteria:
Inclusion Criteria:

male or female between 18 and 75 years of age;
have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

a history of allergy or hypersensitivity to salicylates or aminosalicylates;
a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
current renal or hepatic disease;
participated in any drug or device clinical study within 30 days of entry;
currently enrolled in any other clinical study;
received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
received any other topical rectal therapy during the week prior to the Screening Visit;
received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
if female, positive pregnancy test, or lactating.
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Eligibility criteria:
Inclusion Criteria:

male or female between 18 and 75 years of age;
have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

a history of allergy or hypersensitivity to salicylates or aminosalicylates;
a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
current renal or hepatic disease;
participated in any drug or device clinical study within 30 days of entry;
currently enrolled in any other clinical study;
received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
received any other topical rectal therapy during the week prior to the Screening Visit;
received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
if female, positive pregnancy test, or lactating.
Intervention: Nevirapine
Trial phase: Phase 3
ATC code: J05AG01 | J05AR05 | J05AR07
SMILES: Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 758
Group description: For infants: extended treatment with NVP
Eligibility criteria:
Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information.

Inclusion Criteria for Mothers:

18 years of age or older
HIV infected
In third trimester of pregnancy, or at most 3 days post-delivery
If baby is not yet born, planning to deliver at a facility where the study is being conducted
Plan to breastfeed

Exclusion Criteria for Mothers:

Complications with this pregnancy
Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician

Inclusion Criteria for Infants:

Born to an HIV infected mother who is eligible for the study
Weighed at least 2000 grams (4.4 lbs) at birth
Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT
Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group
Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding)

Exclusion Criteria for Infants:

HIV DNA PCR positive at birth
ALT of Grade 2 or higher at birth
Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
Skin rash of Grade 2B (urticaria), Grade 3, or above
Confirmed or suspected clinical hepatitis
Serious illness or condition that would interfere with compliance with study procedures
Intervention: Calcium Phosphate
Trial phase: Phase 2
ATC code: A11GB01 | A12AA01
SMILES: O=P([O-])([O-])[O-].O=P([O-])([O-])[O-].[Ca+2].[Ca+2].[Ca+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
Eligibility criteria:
Inclusion Criteria:

Bone mineral density (BMD) T-score less than -1.0
One or more vertebral fractures
Serum creatinine less than 1.3 mg/dL
Serum phosphorus less than 3.6 mg/dL
Daily phosphorus intake below NHANES-III median
Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

Paget's disease or history of osteosarcoma
Systemic corticosteroid therapy
Hyperparathyroidism
Recent history of kidney stone
Anticonvulsant therapy known to alter vitamin D metabolism
Radiation therapy to bone
Intervention: CALCIUM CARBONATE
Trial phase: Phase 2
ATC code: A02AC01 | A11GB01 | A12AA04
SMILES: O=C([O-])[O-].[Ca+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Eligibility criteria:
Inclusion Criteria:

Bone mineral density (BMD) T-score less than -1.0
One or more vertebral fractures
Serum creatinine less than 1.3 mg/dL
Serum phosphorus less than 3.6 mg/dL
Daily phosphorus intake below NHANES-III median
Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

Paget's disease or history of osteosarcoma
Systemic corticosteroid therapy
Hyperparathyroidism
Recent history of kidney stone
Anticonvulsant therapy known to alter vitamin D metabolism
Radiation therapy to bone
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: 25
Group description: Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies:

Squamous cell carcinoma
Adenocarcinoma
Large cell carcinoma
Bronchoalveolar carcinoma
All variants of NSCLC

At least 1 bidimensionally measurable brain metastasis

Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable
Biopsy is not required
Not eligible for surgical resection or radiosurgery of brain metastasis
Systemic disease not in immediate need of chemotherapy
Age>=18 years
ECOG Performance status of 0-1
More than 12 weeks of life expectancy

Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL
Bilirubin ≤ 2 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (5 times ULN if liver metastases are present)
Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
Creatinine ≤ 1.6 mg/dL
Fertile patients must use effective contraception
Prior biologic therapy allowed
More than 4 weeks since prior chemotherapy
Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
Prior surgery for brain metastasis allowed

At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered

No prior radiotherapy to ≥ 50% of bone marrow
Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated

Exclusion Criteria:

HIV positive
AIDS-related illness
Poor medical risks due to active nonmalignant systemic disease
Frequent vomiting
There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
Pregnant or nursing
Prior temozolomide
Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
Other concurrent investigational agents
Other concurrent treatment for brain metastasis
Other concurrent chemotherapy during study radiotherapy
Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose
Intervention: Moxifloxacin
Trial phase: Phase 2
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible.
Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation.
Agree to use acceptable methods of contraception

Exclusion Criteria:

History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB
Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated
History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever
Active AIDS-related opportunistic infection or malignancy
Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry
Silicotuberculosis
Central nervous system TB
Pregnant or breastfeeding
Unable to take oral medication
Electrocardiogram (EKG) QTc interval greater than 450 msec
Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant
Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study
Intervention: Moxifloxacin
Trial phase: Phase 2
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible.
Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation.
Agree to use acceptable methods of contraception

Exclusion Criteria:

History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB
Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated
History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever
Active AIDS-related opportunistic infection or malignancy
Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry
Silicotuberculosis
Central nervous system TB
Pregnant or breastfeeding
Unable to take oral medication
Electrocardiogram (EKG) QTc interval greater than 450 msec
Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant
Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study
Intervention: Sertraline
Trial phase: Phase 2 | Phase 3
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Participants will receive sertraline at a target dose of 100mg daily.

Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks
Eligibility criteria:
Inclusion:

Ability of the participant, caregiver or surrogate to provide written informed consent.
Dementia due to Alzheimer's disease
Stable treatment for Alzheimer's disease
Ability for the participant's caregiver to accompany the participant to study visits and participate in the study.

Exclusion

Presence of a brain disease that might otherwise explain the presence of dementia
Clinically significant hallucinations or delusions
Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications
Need for hospitalization or residence in a nursing facility
Intervention: Paroxetine
Trial phase: Phase 3
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Eligibility criteria:
Inclusion Criteria:

To be eligible you must be:

30 years old or older
diagnosed with Parkinson's disease
experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 931
Group description: Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Eligibility criteria:
Inclusion Criteria:

Patients must have schizophrenia
Female patients of childbearing potential must be using a medically accepted means of contraception
Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

Exclusion Criteria:

Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
Female patients must not be pregnant or breast-feeding
Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Intervention: Integrilin
Trial phase: Phase 3
ATC code: B01AC16
SMILES: NC(=O)C1CSSCCC(=O)NC(CCCCN=C(N)N)C(=O)NCC(=O)NC(CC(=O)O)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)N2CCCC2C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4686
Group description: Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
Eligibility criteria:
Inclusion Criteria:

Willing and able to give informed consent and comply with study procedures and follow-up through 1 year.
Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours.
Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome.

Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following:

60 years of age or more
Electrocardiogram changes (ECG)
Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels

Or have all 3 of the following:

Prior history of cardiovascular disease
Elevated troponin or CK-MB levels
50-59 years of age

Exclusion Criteria:

pregnancy (known or suspected)
renal dialysis within 30 days prior to randomizing in study
other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated
Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma.
History of certain hematologic problems following treatment with heparin or eptifibatide.
Therapy with certain related drugs within a short time before randomization into the trial.
Intervention: Tolterodine
Trial phase: Not Applicable
ATC code: G04BD07
SMILES: Cc1ccc(O)c([C@H](CCN(C(C)C)C(C)C)c2ccccc2)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 153
Group description: Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Eligibility criteria:
Inclusion:

Female
Urge predominant incontinence
Incontinent > 3 mos
Available for 8 mos of followup

Exclusion:

Pregnancy or < 6 mos post-partum
Hypersensitivity to drug (tolterodine)
Systemic disease that affects bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
History of extensive behavior treatment
Intervention: Thalidomide
Trial phase: Phase 2
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma

Metastatic disease

Measurable disease

Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

Histologic confirmation required if measurable disease is confined to a solitary lesion

The following are not considered measurable disease:

Bone disease only
Pleural or peritoneal metastases
CNS lesions
Irradiated lesions unless disease progression was documented after prior radiotherapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 mg/dL
No decompensated liver disease

Renal

Creatinine ≤ 2.0 mg/dL

Immunologic

No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system
No history of autoimmune disease
No autoimmune hepatitis
No immunosuppressed transplantation recipients

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation
No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range
No severe psychiatric condition or disorder, including suicidal ideation or attempt
No other active malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
More than 4 weeks since prior radiotherapy

Surgery

Not specified
Intervention: Montelukast
Trial phase: Phase 3
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: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1002
Group description: Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing

Exclusion Criteria:

Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection