anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 161
Group description: avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
Eligibility criteria:
Inclusion Criteria:

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
Androgen replacement therapy that has not been stable for at least 3 month;
Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
ED as a result of spinal cord injury or radical prostatectomy;
Untreated hypogonadism or low serum total testosterone
History of or predisposition to priapism;
Any penile implant;
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
History of type 1 or type 2 diabetes;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
Significant cardiovascular disease;
Abnormal ECG;
Hepatic or renal impairment;
Positive STD screen;
Clinically evident penile lesions, abrasions, or anatomical deformities;
Urinary tract or bladder infection;
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
Participation in another investigational study within 30 days of screening or at any time during this study;
Previous participation in any other investigational study of avanafil;
History or current drug, alcohol, or substance abuse;
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
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: 162
Group description: avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Eligibility criteria:
Inclusion Criteria:

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
Androgen replacement therapy that has not been stable for at least 3 month;
Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
ED as a result of spinal cord injury or radical prostatectomy;
Untreated hypogonadism or low serum total testosterone
History of or predisposition to priapism;
Any penile implant;
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
History of type 1 or type 2 diabetes;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
Significant cardiovascular disease;
Abnormal ECG;
Hepatic or renal impairment;
Positive STD screen;
Clinically evident penile lesions, abrasions, or anatomical deformities;
Urinary tract or bladder infection;
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
Participation in another investigational study within 30 days of screening or at any time during this study;
Previous participation in any other investigational study of avanafil;
History or current drug, alcohol, or substance abuse;
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
Intervention: Abarelix
Trial phase: Phase 2
ATC code: L02BX01
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N(C)[C@@H](Cc1ccc(O)cc1)C(=O)N[C@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Pancreatic Polypeptide

Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
Eligibility criteria:
Inclusion Criteria:

Male and female volunteers between the ages of 18-75 with:
10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for > 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
HbA1c levels ≤ 8.5.

Exclusion Criteria:

Lactating or pregnant females.
Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
Allergy to beef or beef by-products.
Hypoglycemia within the past year requiring medical or other assistance to correct.
Known autonomic neuropathy.
Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
Not currently on pump therapy.
Type 1 DM who has a BMI ≥ 35.
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Ketorolac 0.4%
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

History of intraocular surgery in the operative eye
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 308
Group description: atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
Eligibility criteria:
Inclusion Criteria:

open heart surgery

Exclusion Criteria:

acute coronary syndrome with troponin leak or unrelenting angina
liver dysfunction (transaminases 2x normal)
history of myopathy or liver dysfunction on prior statin therapy
use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
pregnancy or breast feeding
cyclosporine use
dialysis
history of kidney transplant
fibrate users who cannot stop fibrate use.
Intervention: FLUTICASONE FUROATE
Trial phase: Phase 4
ATC code: R01AD12 | R03AK10 | R03AL08 | R03BA09
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(C(=O)SCF)[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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
Eligibility criteria:
Inclusion Criteria:

Males and females between 18 and 45 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin test to grass and/or ragweed antigen.
Positive response to screening nasal challenge.

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 128
Group description: Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate
Eligibility criteria:
Inclusion criteria for communities:

Communities are located in the target districts and accessible by vehicle
The community leaders consent to have the community enrolled
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
The community size is <5,000 persons or >250 persons.

If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

The child is age 5 years or younger
The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
The child must have an identifiable guardian capable of providing consent to participate.
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 128
Group description: Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.

Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Eligibility criteria:
Inclusion criteria for communities:

Communities are located in the target districts and accessible by vehicle
The community leaders consent to have the community enrolled
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
The community size is <5,000 persons or >250 persons.

If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

The child is age 5 years or younger
The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
The child must have an identifiable guardian capable of providing consent to participate.
Intervention: Milnacipran
Trial phase: Phase 3
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
Visual analog pain score between 40 and 90 mm
Right-hand dominance

Exclusion Criteria:

Suicidal risk
Substance Abuse
Pulmonary dysfunction
Renal impairment
Active cardiac disease
Autoimmune disease
Uncontrolled narrow-angle glaucoma
Active liver disease
Cancer
Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue
Unstable endocrine disease
Prostatic enlargement
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: Gabapentin 300mg taken by mouth thrice daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
Access to transportation to meet follow-up requirements.

Exclusion Criteria:

Any reason to be excluded for PRK.
Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
Patients with known depressed renal function.
Any physical or mental impairment that would preclude participation in any of the examinations.
Intervention: Amantadine
Trial phase: Not Applicable
ATC code: N04BB01
SMILES: NC12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Eligibility criteria:
Inclusion Criteria:

Parkinson's Disease
At least 21 years of age
Must be taking Oral levodopa
Must have dyskinesias by history or previous clinical observation

Exclusion Criteria:

Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of < 25
Subjects with unstable medical or psychiatric conditions (including hallucinations)
Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine)
History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.)
Use of anticoagulants
Current substance abuse
Previous adverse event on amantadine
Intervention: Growth hormone
Trial phase: Not Applicable
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Recombinant human growth hormone 6mcg/kg SC once daily
Eligibility criteria:
Inclusion Criteria:

previously diagnosed HIV infection
Stable antiretroviral regimen for at least 12 weeks prior to enrollment
Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of treatment for HIV disease
Subjective evidence of at least one of the following changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face

Exclusion Criteria:

Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months of the study
Use of GH or Growth hormone releasing factor within six months of starting the study
Change in lipid lowering or antihypertensive regimen within 3 months of screening
Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
Carpal tunnel syndrome
Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5ng/mL
Prior history of hypopituitarism, head irradiation, or any other condition known to affect the GH axis
positive beta-HCG (women only)
Oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study
weight < 110 pounds
Intervention: Growth hormone
Trial phase: Not Applicable
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Recombinant human growth hormone 2mg SC once daily
Eligibility criteria:
Inclusion Criteria:

previously diagnosed HIV infection
Stable antiretroviral regimen for at least 12 weeks prior to enrollment
Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of treatment for HIV disease
Subjective evidence of at least one of the following changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face

Exclusion Criteria:

Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months of the study
Use of GH or Growth hormone releasing factor within six months of starting the study
Change in lipid lowering or antihypertensive regimen within 3 months of screening
Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
Carpal tunnel syndrome
Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5ng/mL
Prior history of hypopituitarism, head irradiation, or any other condition known to affect the GH axis
positive beta-HCG (women only)
Oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study
weight < 110 pounds
Intervention: Melatonin
Trial phase: Not Applicable
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Subjects with free-running rhythms will take melatonin.

Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.
Eligibility criteria:
Inclusion Criteria:

Totally blind
Between 5-8 yrs or 17-20 yrs of age

Exclusion Criteria:

Pregnancy
Light perception
Low melatonin production
Taking melatonin
Co-morbid medical disorders (such as seizure disorders)
Intervention: Simvastatin
Trial phase: Phase 1 | Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Simvastatin, 80 mg/day

Simvastatin, 80 mg/day for 21 days: Active treatment group
Eligibility criteria:
Inclusion Criteria:

Age > 18
SAH from ruptured cerebral aneurysm within 48 hours of admission.
Modified Fisher grade 2,3,or 4
Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

Pregnancy
SAH secondary to traumatic or mycotic aneurysms
Pre-ictal statin therapy
Contraindication to stain therapy
WFNS grade 5
Contraindications to MAP elevation on day 7-10
Intervention: Pituitrin
Trial phase: Not Applicable
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
Eligibility criteria:
Inclusion Criteria:

Age >/= 18 yrs,
Primary admission to the hospital within 8 h after injury
Closed head injury
Potential for intracranial pressure monitoring

Exclusion Criteria:

Pregnant or nursing women
Hemodynamic instability after initial resuscitation
Vasopressor therapy for greater than 6 hours