anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: GTS-21
Trial phase: Phase 2
SMILES: [H]/C(=C1/CCCN=C1c1cccnc1)c1ccc(OC)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)

DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
Eligibility criteria:
Inclusion Criteria:

Subjects will be selected to be 18 to 65 years old and in good general health.
Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
Smokers will smoke at least 20 cigarettes per day.
Non-smokers will also be enrolled.

Subjects will have normal:

vital signs,
hematology,
serum chemistries,
EKG, and
urinalysis with a negative drug screen before entry into the study.
Subjects will be fluent in English.
Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.

Exclusion Criteria:

Subjects with histories of:

neurological illness,
liver disease,
severe hypertension (cut-off blood pressure 160/100) or
cardiac disease, or
renal failure (cut-off creatinine above 1.4).
Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
Subjects being treated with Clozapine will be excluded.
Intervention: Doripenem
Trial phase: Phase 4
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: pharmacokinetics/pharmacodynamics
Eligibility criteria:
Inclusion Criteria:

adult neutropenic (< 500 cells) patients who are febrile

Exclusion Criteria:

Patients with Creatinine Clearance < 30 ml/min or allergy to carbapenems will be excluded.
Intervention: Tigecycline
Trial phase: Not Applicable
ATC code: J01AA12 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(NC(=O)CNC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Open non-comparative trial

Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Eligibility criteria:
Inclusion Criteria:

non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.

Exclusion Criteria:

pregnant patients
allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) I, II or III.
Age 18 - 65.
Both male and female.
No significant laboratory abnormalities.

Exclusion Criteria:

Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.
Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.
Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.
No emergency patients will be recruited for this study.
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 993
Group description: IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.

Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists.
Eligibility criteria:
Inclusion Criteria:

Age at least 18 years or local age of consent
Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability
VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity)
Incessant or recurrent VF/VT after receipt of ≥ 1 shocks
Established vascular access

Exclusion Criteria:

Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT
Written advance directive to not attempt resuscitation (DNAR)
Blunt, penetrating, or burn-related injury
Exsanguination
Protected populations (prisoners, pregnancy, children under local age of consent)
Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers
Prior receipt of open label lidocaine or amiodarone during resuscitation
Intervention: Dinoprostone
Trial phase: Not Applicable
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 191
Group description: CERVIDIL (Dinoprostone): INDUCTION OF LABOR
Eligibility criteria:
Inclusion Criteria:

Cervix < 3 cm dilated. If 2cm dilated, must be < 80% effaced.
Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
Singleton gestation
Cephalic presentation

Exclusion Criteria:

Regular uterine contractions (more frequent than every 5 minutes)
PROM
Prior transverse uterine incision or any obstetric contraindication to labor
Fever (defined as a temperature of 38°C or higher)
Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
Fetal death
Placenta previa
Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
Non-reassuring fetal heart rate pattern
HIV
Intervention: Codeine
Trial phase: Phase 3
ATC code: N02AA59 | N02AA79 | N02AJ06 | N02AJ07 | N02AJ08 | R05DA04
SMILES: [H][C@@]12C=C[C@H](O)[C@@H]3Oc4c(OC)ccc5c4[C@@]31CCN(C)[C@@H]2C5
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
Eligibility criteria:
Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications
Intervention: Codeine
Trial phase: Phase 3
ATC code: N02AA59 | N02AA79 | N02AJ06 | N02AJ07 | N02AJ08 | R05DA04
SMILES: [H][C@@]12C=C[C@H](O)[C@@H]3Oc4c(OC)ccc5c4[C@@]31CCN(C)[C@@H]2C5
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
Eligibility criteria:
Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications
Intervention: Hydrocodone
Trial phase: Phase 3
ATC code: R05DA03
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(OC)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
Eligibility criteria:
Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications
Intervention: Verapamil
Trial phase: Not Applicable
ATC code: C08DA01 | C08DA51 | C09BB10
SMILES: COc1ccc(CCN(C)CCCC(C#N)(c2ccc(OC)c(OC)c2)C(C)C)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 591
Group description: Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Eligibility criteria:
Inclusion Criteria:

patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
successful cannulation of the radial artery

Exclusion Criteria:

reduced left ventricular systolic function (LVEF<35%)
significant aortic stenosis
bradycardia (<50/min.)
myocardial infarction complicated by cardiogenic shock and/or high grade AV block
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 2 | Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 16mg buprenorphine plus naltrexone for 8 weeks of treatment
Eligibility criteria:
Inclusion Criteria:

18 to 65 years of age
In good general health
Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
Interested in receiving treatment for cocaine dependence
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
Able to satisfy and comply with study procedures and requirements
If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study

Exclusion Criteria:

Pregnant or breastfeeding females
Known allergy or sensitivity to study medications
Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
Pending action or situation that might prevent remaining in the area for the duration of the study
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: 2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
Eligibility criteria:
Inclusion Criteria:

Patient scheduled to undergo comprehensive dental treatment under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry
ASA I or II health status
Age greater than 3 years but less than 6 years
Weigh between 10kg and 25kg

Exclusion Criteria:

Patient not requiring restorative dental treatment
Have a BMI less than the 5th percentile or greater than the 95th percentile for their age and gender
Intervention: MESALAMINE
Trial phase: Phase 1
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
Eligibility criteria:
Inclusion Criteria

Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.

Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

Male, or
Non-pregnant, non-lactating female
Females must be at least 90 days post-partum or nulliparous.

Exclusion Criteria

A history of current or recurrent disease that could affect the colon. This includes gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel Syndrome. Subjects who have a history of chronic constipation, which is physician diagnosed and treated, will also be excluded from the study (frequency of bowel movements >48 hours between samples).
A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
A history of gastrointestinal surgery performed within the past 12 months prior to the first dose of investigational product, with the exception of an appendectomy.
A history of or current clinically relevant moderate or severe renal or hepatic impairment.
A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
Known or suspected intolerance or hypersensitivity to the investigational product or ciprofloxacin XR, closely related compounds, or any of the stated ingredients
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
Eligibility criteria:
Inclusion Criteria:

Have recently diagnosed (< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) are eligible
Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.
Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin regimen administered weekly (100 mg/m2)
Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
CRP < 80 mg/L
Have adequate hematopoietic, hepatic, and renal function at the screening visit

Exclusion Criteria:

Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor
Metastatic disease (M1) Stage IV C
Any prior history of head and neck cancer
Prior radiation to the head and neck
Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; or anticipation of need for a major surgical procedure during the clinical trial
Active infectious disease, excluding oral candidiasis
Have OM at the screening visit
Have a history of hypersensitivity to monoclonal antibody
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Treatment Period 1: 5 g of 1% transdermal T-gel applied QD

Treatment Period 2:

2.5 g of 1% transdermal T-gel applied QD
5 g of 1% transdermal T-gel applied QD
7.5 g of 1% transdermal T-gel applied QD
10 g of 1% transdermal T-gel applied QD

Safety Follow-up Phase:

Initial dose: ~42 doses Maintenance dose-Titrated dose: ~48 doses Safety follow-up at maintenance dose: ~270 doses

topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
Eligibility criteria:
Inclusion Criteria:

Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
Recent history of stroke, not including transient ischemic attack
Untreated, sever obstructive sleep apnea.
Hematocrit <35% or >48
Serum transaminases >2 times upper limit of normal, serum bilirubin > 2.0 mg/dL and serum creatinine > 2.0 mgk/dL
BMI > or equal to 36
Stable doses of lipid-lowering medication for less than 3 months
Stable doses of oral medication for diabetes for less than 2 months
Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or equal to 19 points.
History of breast cancer
Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
History of abuse of alcohol or any drug substance within the previous 2 years
Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
Blood donation within the 12 week period before the initial study dose.
Intervention: Troglitazone
Trial phase: Phase 3
ATC code: A10BG01
SMILES: Cc1c(C)c2c(c(C)c1O)CCC(C)(COc1ccc(CC3SC(=O)NC3=O)cc1)O2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:

Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
Abnormal nasal transepithelial potential difference (NPD) test OR
A genotype with 2 identifiable mutations consistent with CF AND
One or more clinical features consistent with CF.
Documented positive lower respiratory tract culture for PA at the screening visit plus two documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (must have been a minimum 3 months apart.)
Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.

Exclusion Criteria:

Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry
Presence of a condition or abnormality that would have compromised the participant's safety or the quality of study data, in the opinion of the investigator
History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit
History of hypersensitivity/adverse reaction to aztreonam
History of hypersensitivity/adverse reaction to beta-agonists
History of lung transplantation
Administration of any investigational drug or device within 30 days prior to screening visit or within 6 half-lives of the investigational drug (whichever was longer)
Hospitalization for pulmonary-related illness within 28 days prior to screening visit
Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit
Changes in or initiation of hypertonic saline treatment within 7 days prior to screening visit; for subjects on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline was allowed
Changes in antimicrobial, bronchodilator (BD), corticosteroid or dornase alfa medications within 7 days prior to screening visit;
Changes in physiotherapy technique or schedule within 7 days prior to screening visit
Abnormal renal or hepatic function results at most recent test within the previous 90 days