anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Telcagepant
Trial phase: Phase 3
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 573
Group description: Participants who received at least one dose of telcagepant 140 mg.
Eligibility criteria:
Inclusion Criteria:

History of migraines within the past year
1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
Use acceptable contraception throughout the study
Able to complete the study questionnaire(s) and paper diary
Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

Pregnant or breast-feeding or is expecting to become pregnant during the study
Difficulty distinguishing his/her migraine attacks from tension or interval headaches
A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
Greater than 50 years old at the age of migraine onset
Previously taken telcagepant
Intervention: Ketorolac Tromethamine
Trial phase: Phase 2
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
Onset of migraine prior to age 50;
2-8 moderate to severe migraine headaches per month

Exclusion Criteria:

Subjects receiving any investigational drug within 30 days before study entry;
More than 15 headache days per month;
Known allergy or hypersensitivity to ketorolac and/or excipients;
Allergy to aspirin or other NSAIDs;
Currently receiving other NSAIDs or aspirin;
Medical history that would preclude NSAID use
Intervention: Tetracaine
Trial phase: Phase 4
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Tetracaine 4% gel 1g applied to injection site

tetracaine 4% gel: tetracaine applied prior to 1 injection
Eligibility criteria:
Inclusion Criteria:

Infants between 1 month and 2 years of age receiving palivizumab at Surrey Memorial Hospital for 2 consecutive intramuscular injections during the 2007/8 season
Parents need to complete informed consent.

Exclusion Criteria:

Allergy/sensitivity to tetracaine, or ester type anaesthetics.
Infants who present with fever or illness that prevent administration of palivizumab.
Intervention: Lacosamide
Trial phase: Phase 2
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Lacosamide (LCM) 400 mg/day
Eligibility criteria:
Inclusion Criteria:

Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).

Exclusion Criteria:

Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
Eligibility criteria:
Inclusion Criteria:

Age 35 to 69
Parent with Alzheimer's disease

Exclusion Criteria:

Current use of cholesterol-lowering medication
Active liver disease
History of adverse reaction to statins
Contraindication to lumbar puncture
Elevated lab values (creatine kinase and creatinine)
Use of medications known to interact with statins
History of dementia
Currently pregnant or planning to become pregnant
Use of large quantities of grapefruit juice (more than 1 quart per day)
Current involvement in another investigational drug study
Contraindications to MRI (for MRI sub-study)
Ethical contraindication to placebo (persons with high vascular risk)
Intervention: Qsymia
Trial phase: Phase 2
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Phentermine 15mg/topiramate 100mg
Eligibility criteria:
Inclusion Criteria:

Informed consent
Type 2 Diabetes
BMI 27-42
Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

BP > 150/95
Stroke/MI/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic, or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
History of glaucoma
Pregnancy or breastfeeding
Alcohol abuse
Eating disorder
Excluded medications
Intervention: Indomethacin
Trial phase: Phase 1 | Phase 2
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

Indomethacin: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
Eligibility criteria:
Inclusion Criteria:

Singleton and twin gestations
Intact amniotic membranes
No contra-indications to tocolysis
24-34 weeks gestation by last menstrual period and/or ultrasound
Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement

Exclusion Criteria:

Ruptured amniotic membranes
Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
Non-reassuring fetal heart rate tracings
Contra-indications to indomethacin or nifedipine
Contra-indications to tocolysis
Intervention: Nifedipine
Trial phase: Phase 1 | Phase 2
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
Eligibility criteria:
Inclusion Criteria:

Singleton and twin gestations
Intact amniotic membranes
No contra-indications to tocolysis
24-34 weeks gestation by last menstrual period and/or ultrasound
Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement

Exclusion Criteria:

Ruptured amniotic membranes
Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
Non-reassuring fetal heart rate tracings
Contra-indications to indomethacin or nifedipine
Contra-indications to tocolysis
Intervention: Praziquantel
Trial phase: Phase 2
ATC code: P02BA01 | P02BA03
SMILES: O=C(C1CCCCC1)N1CC(=O)N2CCc3ccccc3C2C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 186
Group description: Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
Eligibility criteria:
Inclusion Criteria:

For screening:

Female, age 18 or over.
Present to a study midwife with suspected pregnancy.
Live in a study village.

For the main study:

Infected with S. japonicum.
Pregnancy as determined by urine pregnancy test.
Age 18 or older.
Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment.
Pregnancy between 12-16 weeks gestation.
Ability to provide informed consent to participate.

Exclusion Criteria:

Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular:

History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease.
Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded.
Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size.
Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum.
For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation.
Presence of cysts in the eye suggestive of neurocysticercosis.
Regular use of a medication for a chronic medical condition.
History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.
Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum).
Twin or higher order pregnancy.
Woman has been enrolled into this study for a previous pregnancy.
Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other, or refuses to provide informed consent.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
Eligibility criteria:
Inclusion Criteria:

Eligible women are at term (≥37 week gestation),
Healthy,
ASA class 1-2,
Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with intrathecal morphine and intravenous ketorolac analgesia for post operative analgesia

Exclusion Criteria:

Women with American Society of Anesthesiologists physical status >2,
Body mass index ≥40 kg/m2,
Known allergy to any of the study medications,
Contraindication to the spinal anesthesia,
History of substance abuse,
History of hallucinations,
Chronic opioid therapy,
Chronic pain.
Intervention: Humalog
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 192
Group description: Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of type 1 diabetes for one year or more
Age 18 years or older
Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1

As determined by the investigator, are capable and willing to do the following:

perform self monitoring of blood glucose (SMBG),
complete patient diaries as required for this protocol,
use the insulin injection device(s) according to the instructions provided,
are receptive to diabetes education,
comply with the required study visits.

Exclusion Criteria:

Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo
Eligibility criteria:
Inclusion Criteria:

18-85 years old inclusive
Subarachnoid hemorrhage diagnosed by CT on admission
Randomizable within 732 hours of subarachnoid hemorrhage
Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
Surgical or endovascular obliteration
Able to obtain written informed consent from patient or surrogate

Exclusion Criteria:

Pregnancy, as confirmed by routine urine test on admission
Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
On Statins, niacin, or fibrate therapy within 30 days of presentation
Any vasospasm on the initial diagnostic angiogram
Glasgow Coma Scale 5 or less at the time of randomization
History of liver disease or active liver disease
Hypersensitivity to statins
Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo
Eligibility criteria:
Inclusion Criteria:

18-85 years old inclusive
Subarachnoid hemorrhage diagnosed by CT on admission
Randomizable within 732 hours of subarachnoid hemorrhage
Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
Surgical or endovascular obliteration
Able to obtain written informed consent from patient or surrogate

Exclusion Criteria:

Pregnancy, as confirmed by routine urine test on admission
Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
On Statins, niacin, or fibrate therapy within 30 days of presentation
Any vasospasm on the initial diagnostic angiogram
Glasgow Coma Scale 5 or less at the time of randomization
History of liver disease or active liver disease
Hypersensitivity to statins
Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label
Intervention: Trimethobenzamide Hydrochloride
Trial phase: Phase 4
SMILES: COc1cc(C(=O)NCc2ccc(OCCN(C)C)cc2)cc(OC)c1OC.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Tigan® : Oral capsule, 300mg three times daily.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 years or over
Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection
Able to swallow Tigan®/placebo capsules
Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception
Willing and able to provide informed consent

Exclusion Criteria:

Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite)
Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®
Previous treatment with Apokyn®
Participation in any other clinical trial within 14 days of the present trial
Contraindications to Apokyn® or Tigan®
Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron)
Malignant melanoma or a history of previously treated malignant melanoma
Pregnancy or breast feeding
Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
Intervention: Fluvastatin
Trial phase: Phase 4
ATC code: C10AA04
SMILES: CC(C)n1c(C=CC(O)CC(O)CC(=O)O)c(-c2ccc(F)cc2)c2ccccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 262
Group description: 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5

Exclusion Criteria:

Any prior treatment with intravenous Bisphosphonates
Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
Patients who are taking, and are unwilling or unable to stop taking, certain medications
Patients who require anticoagulant therapy
Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
Protocol specific laboratory values that fall out of range for this study
Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
History of iritis, uveitis or chronic conjunctivitis
History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
Partial or total removal of parathyroid or thyroid gland
History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Treatment with an investigational drug within the previous 30 days of screening
Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: STANOLONE
Trial phase: Phase 1 | Phase 2
ATC code: A14AA01 | G03BB02
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](O)CC[C@@]34[H])[C@@]1(C)CCC(=O)C2
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: DHT gel (70 mg/day) for one month
Eligibility criteria:
Inclusion Criteria:

Males 35-55 years old
Normal serum total testosterone (300 ng/dl-1000 ng/dl)
Normal Luteinizing Hormone [LH] and Follicle Stimulating Hormone [FSH] levels
Informed consent
Taking no regular medications
Normal baseline prostate ultrasound, hematology, and liver function tests

Exclusion Criteria:

History of prostate cancer
Prostate Specific Antigen [PSA] > 2.0
American Urological Association [AUA] prostate symptom score > 10
History of testosterone or anabolic steroid use in the past
Chronic medical illness or prostate disease
History of a bleeding disorder or need for anticoagulation
A first-degree relative (i.e. father, brother) with a history of prostate cancer
Abnormal digital rectal examination
Skin condition that might interfere with or be exacerbated by DHT gel use
History of untreated sleep apnea and/or psychiatric problems
Participation in another study in the past 2 months
Participating in a regular physical relationship with a pregnant woman