anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gefapixant
Trial phase: Phase 3
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Has a chest radiograph or computed tomography scan of the thorax (within 5 years of Screening and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other lung disease
Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for ≥12 months
Has a diagnosis of refractory chronic cough or unexplained chronic cough
Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥3 months
Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance

Exclusion Criteria:

Is a current smoker
Has given up smoking within 12 months of screening
Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
Has a history of chronic bronchitis
Has a history of surgery to treat SUI within 1 year of screening
Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy
Has other external incontinence device currently or within 1 month of screening
Has a history of Grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening
Has a neurogenic bladder
Has a history of adult nocturnal incontinence
Has a history of continuous urine leakage within 1 month of screening
Has a history of interstitial cystitis
Has a history of neurological disease or injury
Has active or recurrent urinary tract infection
Has a history of having a permanent urinary catheter or any urinary catheterization within 3 months of screening
Has a history of malignancy ≤5 years prior to signing informed consent
Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
Has a known allergy to gefapixant or its excipients
Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
Requires certain medications and/or other therapies that may impact their cough or bladder function
Has previously received gefapixant
Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
Intervention: Gefapixant
Trial phase: Phase 3
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 206
Group description: Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or the subinvestigator
Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
Has a diagnosis of refractory chronic cough or unexplained chronic cough
Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance

Exclusion Criteria:

Is a current smoker
Has given up smoking within 12 months of screening
Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
Has a known allergy to gefapixant or its excipients
Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
Has previously received gefapixant
Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
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: Accepts Healthy Volunteers
Participants at risk: 31
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
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: Accepts Healthy Volunteers
Participants at risk: 30
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
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: Accepts Healthy Volunteers
Participants at risk: 31
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
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: Accepts Healthy Volunteers
Participants at risk: 31
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
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: Accepts Healthy Volunteers
Participants at risk: 32
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
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: Accepts Healthy Volunteers
Participants at risk: 31
Group description: 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Eligibility criteria:
Inclusion Criteria:

Adults who required general anesthesia
General anesthesia with endotracheal intubation (no supraglottic devices)
Signed informed consent
Non-cardiac surgery
Same anesthesiologist

Exclusion Criteria:

Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
Suspected difficult airway
Known allergy to anesthetic drugs
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.

Dexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Eligibility criteria:
Inclusion Criteria:

Cataract surgery candidate and glaucoma present in at least one eye.
Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.

Exclusion Criteria:

Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
Anterior chamber cells present at time of enrollment
Recent febrile illness that precludes or delays participation for 3 months
Pregnancy or lactation
Known allergy to dexamethasone
Known allergy to prednisolone
Treatment with another investigational drug within the last 20 years
Current recreational drug use
Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: Patients assigned to the oral medication condition will continue with ARI-ORAL. ARI-ORAL dosage will be flexible and dosage will be at the discretion of the treating psychiatrist. Patients discontinuing ARI-ORAL study drug after Randomization to oral antipsychotic medication, can remain in active treatment and follow-up within the study, and may be prescribed any of a number of first-line oral antipsychotics.

ARI-ORAL: oral aripiprazole
Eligibility criteria:
Inclusion Criteria:

Is between 18 and 45 years of age, inclusive, at Screening.
Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type.
Has a first episode of a psychotic illness that occurred within the 24 months before entry.
Fluency (oral and written) in the English language.
Exhibits tolerability to ARI ORAL during the Stabilization period.
Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located.
Agrees to abide by the contraceptive requirements of the protocol.
Additional criteria may apply

Exclusion Criteria:

Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury.
Premorbid IQ less than 70.
Is currently pregnant or breastfeeding, or is planning to become pregnant during the study.
Is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole.
History of poor or inadequate response to an adequate trial of oral or injectable aripiprazole.
Has received AL-LAI or IM depot aripiprazole within two months prior to Randomization.
Has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm.
Is currently being treated with clozapine.
Has participated in a clinical drug trial involving any drug within the past two months.
Has a current DSM-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening SCID.
Patient is an imminent danger to himself/herself.
History of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia.
Additional criteria may apply.
Intervention: Goserelin
Trial phase: Phase 4
ATC code: L02AE03
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes

LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic
Eligibility criteria:
Inclusion Criteria:

Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)
Plan to suture with simple interrupted sutures

Exclusion Criteria:

Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints
Patients whose primary language was neither English nor Spanish
Developmentally delayed or disabled patient such that they were unable to give a pain score
Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam
Intervention: Goserelin
Trial phase: Phase 4
ATC code: L02AE03
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: Three applications of LET topical gel, one applied every 10 minutes

LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic
Eligibility criteria:
Inclusion Criteria:

Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)
Plan to suture with simple interrupted sutures

Exclusion Criteria:

Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints
Patients whose primary language was neither English nor Spanish
Developmentally delayed or disabled patient such that they were unable to give a pain score
Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam
Intervention: Vocacapsaicin
Trial phase: Phase 1 | Phase 2
SMILES: CNCC1CCCCN1C(=O)Oc1ccc(CNC(=O)CCCC/C=C/C(C)C)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Single administration

CA-008: Local administration during surgery
Eligibility criteria:
Inclusion Criteria:

Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
Aged 18-80 years old
ASA physical class 1, 2, or 3
BMI </= 42 kg/m2
Generally healthy

Exclusion Criteria:

Concurrent condition requiring analgesic treatment during study period
Opioid tolerant
Known allergy to capsaicin or other study medication
Use of prohibited medications
Intervention: Vocacapsaicin
Trial phase: Phase 1 | Phase 2
SMILES: CNCC1CCCCN1C(=O)Oc1ccc(CNC(=O)CCCC/C=C/C(C)C)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Single administration

CA-008: Local administration during surgery
Eligibility criteria:
Inclusion Criteria:

Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
Aged 18-80 years old
ASA physical class 1, 2, or 3
BMI </= 42 kg/m2
Generally healthy

Exclusion Criteria:

Concurrent condition requiring analgesic treatment during study period
Opioid tolerant
Known allergy to capsaicin or other study medication
Use of prohibited medications
Intervention: Chloroethane
Trial phase: Phase 4
ATC code: N01BX01
SMILES: CCCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.
Eligibility criteria:
Inclusion Criteria:

Henry Ford employees

Exclusion Criteria:

People with infections at the site of prep
People with history of hypersensitivity to numbing sprays or chloraprep
Intervention: Chloroethane
Trial phase: Phase 4
ATC code: N01BX01
SMILES: CCCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: An area of skin on the lower back of an individual's skin will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after spray application will be evaluated, based on the number of colony forming units that are present.
Eligibility criteria:
Inclusion Criteria:

Henry Ford employees

Exclusion Criteria:

People with infections at the site of prep
People with history of hypersensitivity to numbing sprays or chloraprep
Intervention: Sotalol
Trial phase: Phase 3
ATC code: C07AA07 | C07BA07 | C07FX02
SMILES: CC(C)NCC(O)c1ccc(NS(C)(=O)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.

Antiarrhythmic drug: Continuation of amiodarone or sotalol.
Eligibility criteria:
Inclusion Criteria:

Age >18 years.
Able to give written, informed consent
Structural heart disease.
Implanted and normally functioning ICD or undergoing ICD implant at index admission.
Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT.
Receiving a class III AADs prior to VT ablation.
No VT inducible at the end of VT ablation.
No VT inducible on non-invasive programmed stimulation following VT ablation.

Exclusion Criteria:

LV assist device in place
Decompensated heart failure and/or requiring continuous inotropic therapy and/or awaiting cardiac transplantation
Ongoing acute coronary syndrome.
Mechanical prosthetic aortic and mitral valves.
Pedunculated or mobile left ventricular thrombus.
Persistent VT at the end of index catheter ablation.
Absolute contraindications for class III AADs.
Participation in other trial.
VT induced on NIPS after VT ablation.
Another reason for continuation of class III AADs (i.e., atrial fibrillation).
Intervention: OXYTOCIN
Trial phase: Phase 3
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day
Eligibility criteria:
Inclusion Criteria:

Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.
Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of > 16.
Subjects must have tinnitus loudness rating of >4/10.

Exclusion Criteria:

Subjects who are being treated for tinnitus < 6 months due to the acute nature of their condition
Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale.
Those with tinnitus of a muscular or vascular etiology
Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray.
Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions.
Subjects who suffer from migraines.
Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.