anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
Eligibility criteria:
Inclusion Criteria:

Patients with moderate to severe aortic stenosis (AVA < 1.5 cm2)
Left ventricular hypertrophy
Diastolic dysfunction as evidenced by tissue Doppler e' (average of septal and lateral) ≤ 7 cm/s
EF ≥ 50%
None or minimal symptoms related to aortic stenosis (NYHA ≤ 2)
The subject and treating physician are not planning on a valve replacement procedure to occur during the next 6 months
Ambulatory
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Contraindication to MRI
Creatinine clearance < 30 mL/min
Cirrhosis
Pulmonary fibrosis
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent
Intervention: Difluprednate
Trial phase: Phase 2
ATC code: D07AC19
SMILES: [H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 107
Group description: Difluprednate 0.05% ophthalmic emulsion
Eligibility criteria:
Inclusion Criteria:

Normal subjects:

No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.

OR

Dry eye patients:

At least a 6 month history of dry eye.
Non-contact lens wearer.
Uses artificial tears.
Experiences persistent ocular discomfort.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.
History of glaucoma or ocular hypertension
Other protocol-defined exclusion criteria may apply.
Intervention: Nuvaring
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 714
Group description: Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
Eligibility criteria:
Key Inclusion Criteria:

Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
Body mass index ≥18 and ≤29 kg/m^2

Key Exclusion Criteria:

Contraindications for contraceptive steroids
Abnormal cervical smear corresponding to indeterminate changes at screening
Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Intervention: Cisplatin
Trial phase: Phase 2
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: HIPEC with Cisplatin
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 1 years
Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit
Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist.
Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, pregnant or lactating females.
Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space.' Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist.
Patients must have adequate renal function (serum creatinine </= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years of age)
Patients will be eligible if the white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (ANC) is >/=1,500 and platelets are >/= 100,000/mm^3
Patients will be eligible if serum total bilirubin and liver enzymes are </=2 times the upper limit of normal
Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment

Exclusion Criteria:

Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
Patients who have failed previous intraperitoneal platinum therapy will be ineligible
Patients with Retroperitoneal Liposarcoma will be ineligible.
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: FENTANYL
Eligibility criteria:
Inclusion Criteria:

18-64 years of age
Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])

Exclusion Criteria:

obesity (body mass index >30)
pregnancy
history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease
history of alcohol and drug abuse
requiring tracheal intubation.
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: SALINE
Eligibility criteria:
Inclusion Criteria:

18-64 years of age
Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])

Exclusion Criteria:

obesity (body mass index >30)
pregnancy
history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease
history of alcohol and drug abuse
requiring tracheal intubation.
Intervention: Hydroxypropylmethylcellulose
Trial phase: Phase 4
SMILES: CC(O)COCC1OC(OC2C(COCC(C)O)OC(OCC(C)O)C(OCC(C)O)C2OCC(C)O)C(OCC(C)O)C(OCC(C)O)C1OCC(C)O.COCC1OC(OC2C(COC)OC(OC)C(OC)C2OC)C(OC)C(OC)C1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: One group will receive preserved lubricating drops 4 times a day for 1 month.
Eligibility criteria:
Inclusion Criteria:

Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

Use of any eyedrop.
Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
Previous history of cystoid macular edema.
Previous ocular surgery other than cataract surgery.
Intervention: 7H
Trial phase: Phase 4
SMILES: CC(=O)O.O=CC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
Eligibility criteria:
Inclusion Criteria:

Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

Use of any eyedrop.
Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
Previous history of cystoid macular edema.
Previous ocular surgery other than cataract surgery.
Intervention: Dopamine
Trial phase: Phase 2 | Phase 3
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.

Levodopa/carbidopa: Levodopa/Carbidopa (4:1)

Dosages are based on levodopa.

Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Eligibility criteria:
Inclusion Criteria:

Age between 4 years and 12 years (i.e., before the 13th birthday)
Molecular confirmation of the diagnosis of AS, which may include abnormal methylation studies or UBE3A mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll
Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation

Exclusion Criteria:

Co-morbid disorders that may be associated with developmental or cognitive delays
Poorly controlled seizures - An average of more than 2 clinical seizures per month in the 12 months prior to enrollment.
Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months
Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders
Pregnancy
Intervention: Tretinoin
Trial phase: Phase 2
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Tretinoin 0.02% cream
Eligibility criteria:
Inclusion Criteria:

Age 35 or over
Moderate to severe photodamage

Exclusion Criteria:

History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
History of keloids or hypertrophic scars
Use of oral steroids or oral retinoids (such as Accutane) in past 6 months
Intervention: Bortezomib
Trial phase: Phase 2
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Eligibility criteria:
Inclusion Criteria:

Adult Multiple Myeloma patients in partial response or better after high dose chemotherapy and autologous stem cell transplantation
Patient fulfills defined laboratory requirements within 14 days before enrolment
If female, is either postmenopausal for more than 24 consecutive months or surgically sterilized or willing to use an acceptable method of birth control for defined period
If male, agree to use an acceptable barrier method of contraception and to not donate sperm up to 3 months following treatment

Exclusion Criteria:

Patient received another antimyeloma or experimental therapy following autologous stem cell transplantation
Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater intensity as defined by the NCI common terminology criteria of adverse event (NCI CTCAE) version 3.0
Patient has an uncontrolled or severe cardiovascular disease within 6 months of enrolment
Patient has any conditions that would compromise his/her well-being or the completion of the study requirements
Intervention: Epirubicin
Trial phase: Phase 3
ATC code: L01DB01 | L01DB03
SMILES: COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1051
Group description: Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Eligibility criteria:
Inclusion Criteria:

Written informed consent is obtained.
Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
other criteria may apply; please contact the investigator for more information.

Exclusion Criteria:

The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
The patient is a current smoker.
The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
The patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [GERD]).
Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
The patient has a current infection or disease that may preclude assessment of asthma.
other criteria may apply; please contact the investigator for more information.
Intervention: Efavirenz
Trial phase: Not Applicable
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Efavirenz: efavirenz 600 mg PO once daily
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18-65 years;
Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
Absolute T-cell CD4+ subset between 200-500/mm3
Individual willing to undergo serial lumbar punctures as outlined in study evaluations;
Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);
Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

Exclusion Criteria:

Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
Use of prescribed drugs with known substantial interactions with the study drugs;
Positive HCV serology;
HIV-associated dementia/Global Deterioration Scale ≥4;
Pregnancy;
Serum creatinine higher than 2.0 mg/dL;
Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal
Intervention: Finasteride
Trial phase: Phase 4
ATC code: D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 306
Group description: Finasteride 5mg every day by mouth for 3 months
Eligibility criteria:
Inclusion Criteria:

Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
Patient has been recommended to undergo and plans to have a prostate biopsy.
Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
No allergy to finasteride or other five alpha reductase inhibitors.
Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

Risk of cancer greater than 60% or less than 20%.
Prior history of prostate cancer.
Prior treatment with finasteride or dutasteride in the past 6 months
Younger than age 55.
Intervention: Nuvaring
Trial phase: Not Applicable
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: NuvaRing for IVF pre-treatment
Eligibility criteria:
Inclusion Criteria:

Patients less than 38 years of age.
Healthy women starting their first IVF/ICSI cycle.
No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
Consent to randomization.

Exclusion Criteria:

Any contraindication to COC use.
Hypersensitivity to Nuva ring or any of its components.
Language barrier to consent.
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
Eligibility criteria:
Inclusion Criteria:

Adult patients 18-80 years of age

World Health Organization Group 1 PAH

Idiopathic PAH
Heritable PAH
PAH associated with connective tissue disease
PAH associated with surgical repair of congenital left to right shunt
PAH associated with anorectic drug use
WHO functional Class III-IV
6 minute walking distance > 150-meters and < 450 meters
Right heart catheterization showing mean PAP (pulmonary arterial pressure)> 25 mmHg and PCWP (pulmonary capillary wedge pressure) < 15 mmHg within 6 months of study entry.

Exclusion Criteria:

Pulmonary hypertension associated with

a. Portal hypertension b. HIV infection c. Pulmonary venous hypertension defined as PCWP > 15 mmHg d. Chronic lung disease defined as i. FEV1(forced expiratory volume at one second

)/FVC (forced vital capacity) less than 0.65 ii. TLC < 0.70 iii. Untreated Sleep Apnea with AHI (apnea-hypopnea index )> 20 or hemoglobin oxygen saturation nadir < 87% e. Chronic Thromboembolic Disease f. Sarcoidosis g. Pulmonary veno occlusive disease (PVOD)

Concomitant use of nitrates (any form) either regularly or intermittently.
Concomitant use of potent CYP3A inhibitors (e.g., ritonavir, ketoconazole, itraconazole)
Vascular disease of the retina including retinitis pigmentosa, any sudden vision loss, including any damage to the optic nerve or NAION
low blood pressure or high blood pressure that is not controlled
Postural hypotension
Inability to manage home infusion therapy
Pulmonary vasodilator therapy with any phosphodiesterase inhibitor or endothelin receptor antagonist within 30 days of study entry
Participation in a clinical investigational study within previous 30 days

Renal failure defined as:

estimated creatinine clearance < 30 ml/min
serum creatinine > 2.5 mg/dl
Subjects with liver function abnormalities (ALT [Alanine Aminotransferase or AST (Alanine Aminotransferase ) > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
History of hypersensitivity reaction or adverse effect related to tadalafil
Life expectancy < 12 months
History of deformed penis shape, an erection that lasted more than 4 hours, or Peyronie's disease.
Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Pregnant or planning to become pregnant or breast feed.