anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
Eligibility criteria:
Key Inclusion Criteria:

HCV RNA ≥ 10^4 IU/mL at screening
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

Any other chronic liver disease
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Clinical hepatic decompensation
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Group B - antiemetic

Antiemetic: Antiemetic
Eligibility criteria:
Inclusion Criteria:

Patient Age 1-18 yo
Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
Past history of PONV susceptibility

Exclusion Criteria:

Patient/ Parents refusal
Infection at the site of local anesthetic injection
Known coagulopathy
Existing VP shunt
Severe mental disability
Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)
Intervention: Augmentin
Trial phase: Not Applicable
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
Eligibility criteria:
Inclusion Criteria:

Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

Exclusion Criteria:

Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.
Intervention: Betamethasone
Trial phase: Phase 3
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: Child | Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit

Dexamethasone
Eligibility criteria:
Inclusion Criteria:

History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion Criteria:

pregnancy
severe chronic cardiac, respiratory, neurological or neuromuscular disease
complete resolution of symptoms after one treatment of beta agonists
severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
Intervention: 5,6,9,13,17,23,24,27,31,35-Decamethyl-10,28-dioctyl-2,20-diazanonacyclo[19.15.0.03,19.05,17.06,14.09,13.023,35.024,32.027,31]hexatriaconta-1(21),2,19-triene
Trial phase: Phase 3
SMILES: CCCCCCCCC1CCC2(C)C3CCC4(C)Cc5nc6c(nc5CC4(C)C3(C)CCC12C)CC1(C)CCC2C3(C)CCC(CCCCCCCC)C3(C)CCC2(C)C1(C)C6
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: This procedure will be performed either in a minor procedure room or the hand clinic as per surgeon's routine practice. Collagenase will be administered with or without local anesthesia. As this is a pragmatic study there may be more than one digit injected at a time just as surgery occurs on more than one digit at a time. A recently published study by Gaston et al confirmed that two concurrent injections of collagenase to 2 affected joints in the same hand are generally well tolerated and the frequency of most adverse events (AEs) is similar to those reported in studies that use single sequential injections.

collagenase injection: injection
Eligibility criteria:
Inclusion Criteria:

Canadian Citizen
18 years of age or older
Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at least 1 finger (not the thumb)
Demonstrated inability to simultaneously place the affected finger and palm flat on a table
Able to understand and communicate in English

Exclusion Criteria:

Previous treatment of the primary joint within 90 days of study inclusion
Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release)
Persistent extension deficit from a previous surgery of the same digit
Any chronic muscular or neuromuscular disorder affecting wrist or hand
Patient generally unfit for surgery
Patient with specific treatment preference
Bleeding disorder or recent stroke
Allergy to collagenase
Collagenase treatment or treatment with any investigational drug within 30 days of study inclusion
Use of a tetracycline derivative within 14 days of first dose of study drug (because tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs [i.e., matrix metalloproteinases])
Pregnant or breast feeding patients
Patients who do not have insurance coverage for collagenase injections
Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or neuro-psychological problems.
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of prostate cancer (by prostate biopsy)
Scheduled to undergo a prostatectomy
Ability to give his own consent to participate in the study

Exclusion Criteria:

Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
Vitamin D3 supplementation greater than or equal to 1000 IU daily
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.

The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.

Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
Eligibility criteria:
Inclusion Criteria:

preterm infants less than 32 weeks of gestational age
Postnatal age more than 7 weeks
Informed parental consent

Exclusion Criteria:

anomalies in cardiac conduction
congenital malformations
severe intraventricular haemorrhage (grade 3 or 4) or with periventricular leukomalacia
Intervention: Nitrofurantoin
Trial phase: Phase 4
ATC code: J01XE01 | J01XE51
SMILES: O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Receives once daily nitrofurantoin 100mg

Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.
Eligibility criteria:
Inclusion Criteria:

- Women who have undergone surgery for the correction of pelvic organ prolapse and/or urinary incontinence and failed a postoperative voiding trial

Exclusion Criteria:

Known drug allergy to nitrofurantoin
History of renal insufficiency
Renal transplant
Renal nephropathy
Recent history of more than 3 UTIs per year
History of nitrofurantoin-induced pulmonary injury or nitrofurantoin associated cholestatic jaundice/hepatic dysfunction
Known immunocompromised condition (organ transplant, chemotherapy, immune suppression associated with autoimmune disease).
Intervention: Tenapanor
Trial phase: Phase 3
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 312
Group description: Tenapanor, 50 mg BID (100 mg total)
Eligibility criteria:
Inclusion Criteria:

Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization

Exclusion Criteria:

Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
Pregnant or lactating women
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated.

Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing surgery with general anesthesia
Patients weighing > or = 80 pounds
Patients not intubated prior to surgery
Patients who are able to give informed consent

Exclusion Criteria:

Patients unable to give informed consent.
Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
Patients who are anticipated to remain intubated in recovery period.
Intervention: Isoflurophate
Trial phase: Phase 2
ATC code: S01EB07
SMILES: CC(C)OP(=O)(F)OC(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg

Deferiprone: 600 mg tablets
Eligibility criteria:
Inclusion Criteria:

Male or female aged ≥18 to < 80 years
Body weight ≥60 kg but ≤100 kg
Parkinson's disease diagnosed
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (≥1.0 x 10^9/L for Black population) at screening
On a stable dose for at least 3 months prior to the screening visit of any of the following treatments at an L-dopa equivalent daily dose of up to 600 mg:
Dopaminergic agonist alone
L-dopa alone
Combination therapy with dopaminergic agonist and L-dopa
Rasagiline
At an early stage of the disease, without motor fluctuations and/or L-dopa-induced dyskinesia

Exclusion Criteria:

Diagnosis of Parkinson's disease more than 3 years prior to screening visit
Hoehn and Yahr stage ≥ 3
Atypical or secondary Parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy)
Progressing Axis I psychiatric disorders (psychosis, hallucinations, compulsive disorders, substance addiction, bipolar disorder, severe depression, anxiety) as assessed in a semi-structured interview in accordance with the Diagnostic and Statistical Manual of Mental Disorders
Not stabilized in terms of the current antiparkinsonian therapeutic regimen: already requires dose adaptation and/or is likely to require any change in dopamine therapy over the duration of the trial
Current treatment with bromocriptine
Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria
Current treatment with coenzyme Q10 or idebenone. (Patients who are on these medications but stop taking them at least 2 weeks prior to baseline may be enrolled.)
Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)
Intervention: Victoza
Trial phase: Phase 4
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 980
Group description: Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks.
Eligibility criteria:
Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Intervention: Natamycin
Trial phase: Phase 3
ATC code: A01AB10 | A07AA03 | D01AA02 | G01AA02 | S01AA10
SMILES: CC1CC=CC=CC=CC=CC(OC2OC(C)C(O)C(N)C2O)CC2OC(O)(CC(O)CC3OC3C=CC(=O)O1)CC(O)C2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Standard of care topical treatment for fungal keratitis

Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe corneal ulcer that is smear positive for filamentous fungus
Pinhole visual acuity worse than 20/70 in affected eye
Basic understanding of the study as determined by the physician
Commitment to return for follow up visits

Exclusion Criteria:

Gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba)
Impending or frank perforation at recruitment
Involvement of sclera at presentation
Non-infectious or autoimmune keratitis
History of corneal transplantation or recent intraocular surgery
No light perception in the affected eye
Pinhole visual acuity worse than 20/200 in the unaffected eye
Pregnant women
Participants who are decisionally and/or cognitively impaired
Intervention: Zopiclone
Trial phase: Phase 3
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 206
Group description: Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.

Zopiclone: This night sedation will be given to any patient requesting it, in either group
Eligibility criteria:
Inclusion Criteria:

Be 18 years of age.
Be expected to stay in Oxford University Hospitals National Health Service (NHS) Foundation Trust for at least one night.
Be able to understand and use earplugs and eye mask.
Have basic understanding of English reading and writing.
Be considered likely to have the Mental Capacity to give consent for use of personal data in the study at the point of filling in the SleepSure Questionnaire (time of discharge). Data will not be collected from individuals who are unable to give consent with the filling in of the SleepSure questionnaire.
Be expected to be able to fill in the SleepSure Questionnaire at the point of discharge with or without assistance.

Exclusion Criteria:

They have or are expected to have an obvious medical contra-indication to the use of earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical judgement of recruiter.
They are unlikely to benefit from the intervention in the judgement of the recruiter (i.e. individuals who are deaf and blind).
Intervention: Glucagon
Trial phase: Phase 2
ATC code: H04AA01
SMILES: CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump

G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Eligibility criteria:
Inclusion Criteria:

diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion Criteria:

documented hypoglycemia occurring in the fasting state (> 12 hours fast);
chronic kidney disease stage 4 or 5;
hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;
congestive heart failure, New York Heart Association class II, III or IV;
history of myocardial infarction, unstable angina or revascularization within the past 6 months;
history of a cerebrovascular accident;
seizure disorder (other than with suspect or documented hypoglycemia);
active treatment with any diabetes medications except for acarbose;
active malignancy, except basal cell or squamous cell skin cancers;
personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
known insulinoma;
major surgical operation within 30 days prior to screening;
hematocrit ≤ 33%;
bleeding disorder, treatment with warfarin, or platelet count <50,000;
blood donation (1 pint of whole blood) within the past 2 months;
active alcohol abuse or substance abuse;
current administration of oral or parenteral corticosteroids;
pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
use of an investigational drug within 30 days prior to screening.
there will be no involvement of special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: 2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Clonidine: Clonidine 1 µg/kg plus 2% lidocaine
Eligibility criteria:
Inclusion Criteria:

Adults between 30 and 86 years old
Both genders
Physical status ASA (American Society of Anesthesiologists) I and II
Cooperative patients undergoing cataract surgery by phacoemulsification

Exclusion Criteria:

Patients with communication difficulties
Allergic to any medication protocol
Chronic therapy with clonidine
In use of antihypertensive medication
Diabetes
Glaucoma
Previous surgery in the same eye
Abnormalities in coagulation
Intervention: Twynsta
Trial phase: Phase 4
SMILES: CCCc1nc2c(C)cc(-c3nc4ccccc4n3C)cc2n1Cc1ccc(-c2ccccc2C(=O)O)cc1.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Eligibility criteria:
Inclusion Criteria:

Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation;
Ineffective therapy by at least one of the class I or III antiarrhythmic drugs;
Left atrial diameter 5 cm or less;
Estimated catheter radiofrequency pulmonary vein antrum isolation;
Signed informed consent.

Exclusion Criteria:

Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin;
Left atrial thrombosis;
Age greater than 75 years;
Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions;
Malignant growth in the hematogenic dissemination stage.
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr

Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Eligibility criteria:
Inclusion Criteria:

Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).
Must be able to read and understand English and consent for themselves
Previously implanted CardioMems continuous PA pressure
Ambulatory and able to complete 6MWD test.

Exclusion Criteria:

Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.