anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: PF-00489791
Trial phase: Phase 2
SMILES: CCOCCn1nc(C(=O)NS(C)(=O)=O)c2nc(N(C)CC)nc(Nc3cc(C)ccn3)c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
Eligibility criteria:
Inclusion Criteria:

Idiopathic or familial pulmonary arterial hypertension (PAH)
Mean PAP at least 25 mm Hg, PCWP < 15 mm Hg at rest
For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
Signed and dated informed consent
Willingness to comply with the study plan and procedures

Exclusion Criteria:

pulmonary arterial hypertension (PAH)other than idiopathic or familial
For females, pregnancy or lactation
Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
HIV positive subjects
Subjects participating in another clinical trial with an investigational drug or device
Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
Allergies and previous intolerance of PDE5 inhibitors
Alcohol or drug abuse
Blood donation during the study, or 1 month before or after the study
Intervention: PF-00489791
Trial phase: Phase 2
SMILES: CCOCCn1nc(C(=O)NS(C)(=O)=O)c2nc(N(C)CC)nc(Nc3cc(C)ccn3)c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
Eligibility criteria:
Inclusion Criteria:

Idiopathic or familial pulmonary arterial hypertension (PAH)
Mean PAP at least 25 mm Hg, PCWP < 15 mm Hg at rest
For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
Signed and dated informed consent
Willingness to comply with the study plan and procedures

Exclusion Criteria:

pulmonary arterial hypertension (PAH)other than idiopathic or familial
For females, pregnancy or lactation
Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
HIV positive subjects
Subjects participating in another clinical trial with an investigational drug or device
Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
Allergies and previous intolerance of PDE5 inhibitors
Alcohol or drug abuse
Blood donation during the study, or 1 month before or after the study
Intervention: PF-00489791
Trial phase: Phase 2
SMILES: CCOCCn1nc(C(=O)NS(C)(=O)=O)c2nc(N(C)CC)nc(Nc3cc(C)ccn3)c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
Eligibility criteria:
Inclusion Criteria:

Idiopathic or familial pulmonary arterial hypertension (PAH)
Mean PAP at least 25 mm Hg, PCWP < 15 mm Hg at rest
For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
Signed and dated informed consent
Willingness to comply with the study plan and procedures

Exclusion Criteria:

pulmonary arterial hypertension (PAH)other than idiopathic or familial
For females, pregnancy or lactation
Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
HIV positive subjects
Subjects participating in another clinical trial with an investigational drug or device
Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
Allergies and previous intolerance of PDE5 inhibitors
Alcohol or drug abuse
Blood donation during the study, or 1 month before or after the study
Intervention: Pregabalin
Trial phase: Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: pregabalin and placebo given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Adult women age 18 or greater
Vulvodynia as defined as chronic vulvar discomfort or pain, characterized by burning, stinging, irritation or rawness of the female genitalia in cases in which there is no infection or skin disease of the vulva or vagina causing these symptoms. Pain may be constant or intermittent, localized or diffuse. Symptoms may be consistent with either Generalized Vulvodynia (diffuse or focal and constant or unremitting symptoms present in the labia majora, labia minora, and/or the vestibule that are not necessarily caused by touch or pressure to the vulva) or Vulvar Vestibulitis Syndrome (pain only in the vestibule and only during or after touch or pressure is applied).
Pain ≥ 40 on 100mm VAS
Practicing reliable form of birth control defined as sterilization, hormonal contraception, abstinence, IUD
Must be able to attend follow up visits and are not likely to leave the area during the study period

Exclusion Criteria:

Atrophic vaginitis, active bacterial vaginosis, yeast, and herpetic infections
Current pregnancy diagnosed by positive serum or urine pregnancy test
Current breastfeeding
Seizure disorder or other chronic neurologic disease
Diagnosis of chronic renal insufficiency defined as creatinine >1.4
Unable to read and speak English
Contraindication to pregabalin or history of prior use of pregablin
Chronic narcotic or benzodiazepine use
Chronic alcohol abuse
Other chronic pain disorders, (ie. chronic pelvic pain, endometriosis, interstitial cystitis)
Chronic neuropathic pain or anything affecting sensation (ie. MS, stroke)
Intervention: Pregabalin
Trial phase: Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: placebo and pregabalin given using a cross-over design

pregabalin: pregabalin 150mg twice daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Adult women age 18 or greater
Vulvodynia as defined as chronic vulvar discomfort or pain, characterized by burning, stinging, irritation or rawness of the female genitalia in cases in which there is no infection or skin disease of the vulva or vagina causing these symptoms. Pain may be constant or intermittent, localized or diffuse. Symptoms may be consistent with either Generalized Vulvodynia (diffuse or focal and constant or unremitting symptoms present in the labia majora, labia minora, and/or the vestibule that are not necessarily caused by touch or pressure to the vulva) or Vulvar Vestibulitis Syndrome (pain only in the vestibule and only during or after touch or pressure is applied).
Pain ≥ 40 on 100mm VAS
Practicing reliable form of birth control defined as sterilization, hormonal contraception, abstinence, IUD
Must be able to attend follow up visits and are not likely to leave the area during the study period

Exclusion Criteria:

Atrophic vaginitis, active bacterial vaginosis, yeast, and herpetic infections
Current pregnancy diagnosed by positive serum or urine pregnancy test
Current breastfeeding
Seizure disorder or other chronic neurologic disease
Diagnosis of chronic renal insufficiency defined as creatinine >1.4
Unable to read and speak English
Contraindication to pregabalin or history of prior use of pregablin
Chronic narcotic or benzodiazepine use
Chronic alcohol abuse
Other chronic pain disorders, (ie. chronic pelvic pain, endometriosis, interstitial cystitis)
Chronic neuropathic pain or anything affecting sensation (ie. MS, stroke)
Intervention: CID 11593706
Trial phase: Phase 2
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older

Exclusion Criteria:

Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Intervention: CID 11593706
Trial phase: Phase 2
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older

Exclusion Criteria:

Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Intervention: CID 11593706
Trial phase: Phase 2
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older

Exclusion Criteria:

Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 71
Group description: 25 mg oral daily dose of Proellex

Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 71
Group description: 50 mg oral daily dose of Proellex

Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Intervention: Avanafil
Trial phase: Phase 3
ATC code: G04BE10
SMILES: COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 712
Group description: All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Eligibility criteria:
Inclusion Criteria:

Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
Agree to make at least 4 attempts at intercourse each month through the course of this study;
Agree not to use any other treatments for erectile dysfunction during participation in this study.
Provide written informed consent;
Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
Subjects requiring treatment with an excluded medication.
Intervention: Kenalog
Trial phase: Phase 2 | Phase 3
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 0.2cc Triesence

Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound
Eligibility criteria:
Inclusion Criteria:

glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
primary open angle glaucoma
primary angle-closure glaucoma
pseudoexfoliation glaucoma
pigmentary glaucoma
traumatic glaucoma
neovascular glaucoma

Exclusion Criteria:

patients that are pregnant, nursing, or not using adequate contraception
any other eye surgery except cataract surgery
an infection, inflammation, or any abnormality preventing measurement of eye pressure
enrolled in another investigational study
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: glaucoma surgery with balanced salt solution, the standard technique used.

balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.
Eligibility criteria:
Inclusion Criteria:

glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
primary open angle glaucoma
primary angle-closure glaucoma
pseudoexfoliation glaucoma
pigmentary glaucoma
traumatic glaucoma
neovascular glaucoma

Exclusion Criteria:

patients that are pregnant, nursing, or not using adequate contraception
any other eye surgery except cataract surgery
an infection, inflammation, or any abnormality preventing measurement of eye pressure
enrolled in another investigational study
Intervention: Bromfenac Sodium
Trial phase: Phase 3
SMILES: Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: one drop daily in study eye for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

Have known hypersensitivity to bromfenac or to any component of the investigational product
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 2
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
Eligibility criteria:
Key Inclusion Criteria:

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

Key Exclusion Criteria:

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
Other criteria apply