anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Water
Trial phase: Not Applicable
SMILES: O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Administration of placebo similar to oxytocin arm: 4 actuations in each nostril of sterile water with in-clinic observation for 2 hours post-dose in the TI004 study
Eligibility criteria:
Inclusion Criteria:

Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
Headaches typically last for at least 4 hours.
Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

Headache symptoms assessed to be predominately occipital.
Allergy to oxytocin.
History of addictive behavior (e.g. alcoholism, drug abuse).
History of significant psychiatric disorder.
History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
Upper-respiratory tract infection at the time of randomization.
Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
Nasal obstruction of any cause as determined at screening.
Major surgery or trauma within 4 weeks of screening.
Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
Use of an investigational medication or device within 30 days of randomization.
Unable or unwilling to adhere to the study-specific procedures and restrictions.
Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.
Intervention: Water
Trial phase: Not Applicable
SMILES: O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Administration of placebo similar to oxytocin arm: 7 actuations of sterile with 5-minute intervals followed by 4 hours post-dose of in-clinic observation in the TI005 study.
Eligibility criteria:
Inclusion Criteria:

Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
Headaches typically last for at least 4 hours.
Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

Headache symptoms assessed to be predominately occipital.
Allergy to oxytocin.
History of addictive behavior (e.g. alcoholism, drug abuse).
History of significant psychiatric disorder.
History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
Upper-respiratory tract infection at the time of randomization.
Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
Nasal obstruction of any cause as determined at screening.
Major surgery or trauma within 4 weeks of screening.
Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
Use of an investigational medication or device within 30 days of randomization.
Unable or unwilling to adhere to the study-specific procedures and restrictions.
Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.
Intervention: Montelukast Sodium
Trial phase: Phase 3
SMILES: CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 448
Group description: Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Patient has a history of seasonal allergic rhinitis that worsens during the study season
Patient is a nonsmoker
Patient is in good health physical and mental health

Exclusion Criteria:

Patient is hospitalized
Patient is a woman who is < 8 weeks postpartum or is breastfeeding
Patient plans to move or vacation away during the study
Patient has had any major surgery with in past 4 weeks
Patient is a current or past abuser of alcohol or illicit drugs
Intervention: Efavirenz
Trial phase: Phase 2
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).

Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).

efavirenz
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed prostate cancer

Metastatic disease
Castration-refractory disease
No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

Not specified
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: nebulized fentanyl citrate (50 mcg)
Eligibility criteria:
Inclusion Criteria:

Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio <70%;
Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
A cigarette smoking history ≥20 pack-years;
Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
Body mass index (BMI) between 18.5 and 30.0 kg/m2;
Able to perform all study procedures and provide/sign informed consent.

Exclusion Criteria:

A diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted;
Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
Clinical diagnosis of sleep disordered breathing;
A history/clinical evidence of asthma, atopy and/or nasal polyps;
History of allergy or adverse reaction to fentanyl;
Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air;
Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.
Intervention: Tretinoin
Trial phase: Not Applicable
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects are female, between 45 and 55 years of age.
Females of childbearing potential have had a negative urine pregnancy test prior to randomization.
Subjects are willing to use adequate contraceptive method or are surgically sterile (including tubal ligation), post-menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; intra-uterine device (IUD) in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0 or oral contraceptive in use for at least 30 days before Day 0.
Subjects are willing to avoid prolonged exposure to UV radiation for the duration of the study.
Subjects are capable of giving written informed consent.
Subjects have changes associated with facial skin aging/photodamaged skin.

Exclusion Criteria:

Subjects are male.
Subjects are pregnant or lactating.
Subjects have a known allergy to Redermic, Rejuva-A™ or to any component of the tested products.
Subjects have made use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of facial skin aging during the 12 weeks preceding Day 0.
Subjects have applied topical alpha hydroxyl acids within 28 days of Day 0.
Subjects have used or plan to use systemic corticosteroids within 28 days of Day 0 or during the study.
Subjects have made use of a non-medication topical product directed at improving skin aging during the 28 days preceding Day 0.
Subjects have a hypersensitivity to any retinoids.
Subjects have a history of alcohol or drug abuse in the past year.
Subjects are participating in another interventional study.
Subjects have had a previous intense pulsed light treatment to the face.
Subjects have had a previous laser treatment to the face directed at improving skin aging.
Subjects have the presence of skin diseases such as psoriasis or dermatitis on the face that could interfere with study evaluations.
Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker).
Subjects have had a botulinum toxin A injection treatment on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Subjects have had a filler injection (collagen, hyaluronic acid, etc..) on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Intervention: Imiquimod
Trial phase: Phase 2
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
Eligibility criteria:
Inclusion Criteria:

Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
All races will be included as well as male and female.
Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
The majority of port wine stains are initially treated during childhood
In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.

Exclusion Criteria:

Patients under the age of 2 or over the age of 60.
Patients that have serious medical problems that would put them at risk of the anesthesia.
Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Intervention: Dasatinib
Trial phase: Phase 2
ATC code: L01EA02 | L01XE06
SMILES: Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
Eligibility criteria:
Key Inclusion Criteria

Signed written informed consent
Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
Men and women, ages 18 and older

Key Exclusion Criteria

A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
Intervention: Tobramycin
Trial phase: Phase 3
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, b.i.d., given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
Eligibility criteria:
Inclusion Criteria:

Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Intervention: Palonosetron
Trial phase: Phase 2
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Palonosetron 0.25 mg I.V. bolus

Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
Eligibility criteria:
Inclusion Criteria:

Patient must be at least 18 years old.
Patient must have a terminal diagnosis, with estimated survival of 6 months or less.
Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea medications. If the patient is treated with an anti-nausea medication, a minimum of 2 hours should pass to ensure that the medication is given a chance to be effective. If there is no relief after 2 hours, then the patient may be treated with palonosetron.
Patient's medications must be reviewed. Any medications possibly causing nausea should be stopped if possible. For example, if an opiate is suspected of causing nausea, another opiate should be substituted. However, if this is not effective, or if a medication change cannot be made, then the patient would be eligible for this study.
Patient must be able to understand and sign informed consent
Patients who have a bowel obstruction that will not be relieved by surgery may be enrolled. This includes patients whose obstruction is technically unresectable, or who are medically too ill to endure a surgery, or who refuse surgical intervention for any reason

Exclusion Criteria:

Patient has received chemotherapy in the past 28 days.

Assessment of possible causes of the nausea and vomiting should be done and recorded. If a reversible cause of the nausea is identified, that cause should be treated if possible. If the treatment relieves the nausea, then the patient is excluded from this study. Possible reversible causes of nausea and vomiting that should be excluded are:

Other medical conditions such as benign positional vertigo, etc.
Intervention: Fluoxetine
Trial phase: Not Applicable
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.

Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.
Eligibility criteria:
Inclusion Criteria:

Adult patients with temporal lobe epilepsy, aged 18-65.
Medical intractability of seizures such that VET to determine candidacy for epilepsy surgery is determined to be clinically appropriate for the patient by the primary treating epileptologist.
Intelligence Quotient >70.
Native English speaker or adequate fluency in English to provide informed consent.
Female patients of child-bearing potential must be using an acceptable method of contraception, including abstinence.

Exclusion Criteria:

Progressive neurological disease.
Severe depression, bipolar disease or psychosis.
History of suicidal ideation or intent.
Clinically significant concurrent medical illness, including hepatic or renal insufficiency and diabetes.
Pregnant or lactating women.
Current heavy alcohol or illicit drug use.
Patients already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
Concurrent use of monoaminoxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents.
History of a previous allergic reaction or adverse effects with SSRIs.
History of serotonin syndrome.
Intervention: Perflutren
Trial phase: Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)
Eligibility criteria:
Inclusion Criteria:

Primary supratentorial ICH
< 48 hours from symptom onset
Age >18
Signed informed consent obtained from the patient or patient's legally authorized representative

Exclusion Criteria:

ICH volume < 5 cc
Glasgow Coma Scale < 6
Surgical evacuation anticipated
Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
Pregnancy or breastfeeding
Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg)
Current participation in another experimental treatment protocol
Renal impairment with GFR < 30 or Creatinine > 2.0
History of or known allergy to albumin
History of or known severe allergy to rubber latex
Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization)
Acute myocardial infarction in the last 6 months
Elevated serum troponin level on admission > 0.1 mcg/L
Known valvular heart disease with CHF in the last 6 months
Known (or in the investigator's judgment) existence of severe aortic stenosis or mitral stenosis
Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
Suspicion of aortic dissection on admission
Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg).
Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure or without apparent cause; (6) bilateral rales; and/or (7) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution.
Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
Prosthetic heart valves
Contraindication to MRI (metal implant, etc.)
Documented left ventricular ejection fraction < 35%