anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 63
Group description: STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age
Molecular documentation of the fragile X mutation.
Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate or higher at screening and at Visit 1
An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score >12 and at least 3 items on the Irritability Subscale rated at least moderate or above.
Current treatment with no more than three psychoactive medications, including anti-epileptics.
Current pharmacological treatment regimen has been stable for at least 4 weeks.

Exclusion Criteria:

Subjects with a history of seizure disorder who are not currently receiving treatment with antiepileptics.
Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
Subjects who are currently receiving treatment with racemic baclofen.
Subjects currently treated with vigabatrin or tiagabine.
Subjects taking another investigational drug currently or within the last 30 days.
Intervention: Etoricoxib
Trial phase: Phase 3
ATC code: M01AH05
SMILES: Cc1ccc(-c2ncc(Cl)cc2-c2ccc(S(C)(=O)=O)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
Patient has uncontrolled high blood pressure
Patient has a history of drug and/or alcohol abuse within the last 5 years
Patient has taken part in another investigational study within 4 weeks of the start of study
Patient is breast-feeding
Patient has an active ulcer or inflammatory bowel disease
Intervention: Etoricoxib
Trial phase: Phase 3
ATC code: M01AH05
SMILES: Cc1ccc(-c2ncc(Cl)cc2-c2ccc(S(C)(=O)=O)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
Patient has uncontrolled high blood pressure
Patient has a history of drug and/or alcohol abuse within the last 5 years
Patient has taken part in another investigational study within 4 weeks of the start of study
Patient is breast-feeding
Patient has an active ulcer or inflammatory bowel disease
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 4
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 421
Group description: Two sprays in each nostril twice a day for up to 12 months
Eligibility criteria:
Inclusion Criteria:

Sign informed consent;
Normal nasal exam;
History of perennial allergic rhinitis;
Allergy to perennial allergen documented by allergy testing;
Age 12 years and older;
Must follow instructions;
Must make required study visits;
Negative pregnancy test and adequate birth control methods for females of childbearing potential;
Refrain from certain allergy medications during the study;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Nasal disorders;
Use of substances that affect the nasal septum;
Exposure to industrial metal plating solutions;
Uncontrolled, severe, or unstable diseases;
Hypersensitivity to the study drug or nasal spray components;
Relative of site staff with access to the protocol;
Participation in another investigational study within 30 days or at the same time as this study;
Medical Monitor decision;
Other protocol-defined exclusion criteria may apply.
Intervention: Welchol
Trial phase: Phase 3
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 175
Group description: Welchol 625mg tablets

Welchol : Welchol 625mg tablets
Eligibility criteria:
Inclusion Criteria:

Male or female subjects >= 18 years of age;
Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
Diagnosis of Type 2 Diabetes Mellitus;
HbA1C >= 7.5% and =< 9.5 % at screening;
Fasting C-peptide >0.5 ng/mL at screening;
Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
Clinically stable in regards to medical conditions other than type 2 diabetes;
Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
Fasting glucose =< 240 mg/dL at randomization

Exclusion Criteria:

A history of type 1 diabetes and/or a history of ketoacidosis;
History of bowel obstruction;
History of hypertriglyceridemia-induced pancreatitis;
Fasting serum triglyceride concentrations >500 mg/dL;
History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening;
Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period.
Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
Body mass index (BMI) >40 kg/m2;
Weight loss > 3% in prior 3 months; and
LDL <60 mg/dL.
Intervention: Naproxen
Trial phase: Not Applicable
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 129
Group description: participants will be randomized to oral naproxen

naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
Eligibility criteria:
Inclusion Criteria:

Must be of reproductive age from 18 to 45 years
Must be choosing LNG-IUC for contraception
Must be English-speaking
Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study
Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study
Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled
Be willing and able to provide informed consent

Exclusion Criteria:

Known or suspected pregnancy

Contraindication to estrogen use, such as presence or history of:

venous thromboembolism
Arterial thrombosis
Thrombophilia disorders, or known family history of
Hypertension
Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years
Recent or planned future major surgery which will result in prolonged immobilization during the study period
Presence or history of severe hepatic disease or liver tumors
Known or suspected estrogen-dependent neoplasm
Vaginal bleeding of unknown etiology
Any cigarette smoking and age over 35 years

Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of:

Gastrointestinal ulcer disease
Renal insufficiency or failure
Aspirin-induced asthma or hypersensitivity reaction
Systemic lupus erythematosus (SLE) and mixed connective tissue disorders
Use of anticoagulants
Cardiovascular disease
Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure medications
Regular use of an NSAID
Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyp
Hypersensitivity or allergy to any of the components of the estradiol patch
Use of injectable contraception within 6 months of the start of the study medication
Delivery or abortion in the previous 4 weeks
Prior use of LNG-IUD
Any condition, that in the opinion of the investigator, would contraindicate study participation
Intervention: Estradiol
Trial phase: Not Applicable
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 129
Group description: participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Must be of reproductive age from 18 to 45 years
Must be choosing LNG-IUC for contraception
Must be English-speaking
Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study
Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study
Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled
Be willing and able to provide informed consent

Exclusion Criteria:

Known or suspected pregnancy

Contraindication to estrogen use, such as presence or history of:

venous thromboembolism
Arterial thrombosis
Thrombophilia disorders, or known family history of
Hypertension
Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years
Recent or planned future major surgery which will result in prolonged immobilization during the study period
Presence or history of severe hepatic disease or liver tumors
Known or suspected estrogen-dependent neoplasm
Vaginal bleeding of unknown etiology
Any cigarette smoking and age over 35 years

Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of:

Gastrointestinal ulcer disease
Renal insufficiency or failure
Aspirin-induced asthma or hypersensitivity reaction
Systemic lupus erythematosus (SLE) and mixed connective tissue disorders
Use of anticoagulants
Cardiovascular disease
Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure medications
Regular use of an NSAID
Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyp
Hypersensitivity or allergy to any of the components of the estradiol patch
Use of injectable contraception within 6 months of the start of the study medication
Delivery or abortion in the previous 4 weeks
Prior use of LNG-IUD
Any condition, that in the opinion of the investigator, would contraindicate study participation
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1798
Group description: Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Eligibility criteria:
Inclusion Criteria:

> 24 weeks, viable pregnancy, singleton or twins

Exclusion Criteria:

No consent
Contraindication to oxytocin
Antepartum fetal demise
Intrapartum use of concentrated oxytocin
Planned cesarean
DIC or coagulopathy
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7266
Group description: Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
Eligibility criteria:
Inclusion Criteria:

Has T2DM
Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
Has pre-existing cardiovascular disease

Exclusion Criteria:

Has a history of type 1 diabetes mellitus or ketoacidosis.
Is not able to take sitagliptin
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Melatonin
Eligibility criteria:
Inclusion Criteria:

Age 18-69 years.
Diagnosed with ulcerative colitis and currently experiencing a flare up of mild-moderate severity according to Mayo Scoring system (>=4 and <=10).
Has a regular GI physician(s).
Availability for 14 weeks after enrolling in the study.
Female patients of child bearing potential must be surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (i.e., abstinence, oral, intramuscular, or implanted hormonal contraception, 2-barrier methods such as condom, diaphragm or spermicide).

Exclusion Criteria:

Night shift workers; otherwise, inability to attend morning study visits.
Current severe colitis according to the Mayo Scoring System (>10) or requiring hospital admission, or current very mild colitis (<4).
Current supplemental intake of melatonin or currently using tobacco products.
Proctitis or Crohn's disease
Previous gastrectomy or small or large bowel resection
Malabsorption syndrome (e.g., pancreatic insufficiency).
History of large bowel resection for any reason.
Diagnosed narcotic or alcohol dependence.
On renal dialysis.
Active liver disease (a chronic condition or under current therapy)
Seizure disorders
Immune system disorders
Any history of hypo- or hyperparathyroidism.
Unable to be off aspirin for 7 days.
Use of systemic or rectal steroids in the past 8 weeks.
Have a history of allergy or hypersensitivity to melatonin.
History of bleeding disorder or current use of anticoagulant medication.
Current use of calcium channel blockers, anticonvulsants, sedatives, hypnotics, or psychotropic medications.
Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the following 6 months, or are currently taking hormone replacement therapy (HRT).
Intervention: Varenicline
Trial phase: Not Applicable
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.

varenicline: Given orally
Eligibility criteria:
INCLUSION CRITERIA

Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

Interested in quitting smoking

Willing to set a quit date 7 days after baseline assessment

Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

Codac, Inc. (with two independent sites)
Addiction Recovery Institute
Center for Treatment and Recovery
Discovery House
Has received methadone for at least the past month

EXCLUSION CRITERIA

Pregnant or nursing (Must have negative pregnancy test)
Non-English speaking
No personal telephone or does not live close to a relative or neighbor with a telephone
Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
Unvailable for this study for the next 12 months
Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
Active skin condition (e.g., psoriasis)
History of skin allergy
History of a suicide attempt
Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent insulin or blood thinners
No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.

nicotine: Given transdermally and orally
Eligibility criteria:
INCLUSION CRITERIA

Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

Interested in quitting smoking

Willing to set a quit date 7 days after baseline assessment

Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

Codac, Inc. (with two independent sites)
Addiction Recovery Institute
Center for Treatment and Recovery
Discovery House
Has received methadone for at least the past month

EXCLUSION CRITERIA

Pregnant or nursing (Must have negative pregnancy test)
Non-English speaking
No personal telephone or does not live close to a relative or neighbor with a telephone
Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
Unvailable for this study for the next 12 months
Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
Active skin condition (e.g., psoriasis)
History of skin allergy
History of a suicide attempt
Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent insulin or blood thinners
No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
Intervention: Liothyronine
Trial phase: Phase 3
ATC code: H03AA02 | H03AA03
SMILES: NC(Cc1cc(I)c(Oc2ccc(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: liothyronine (T3)

Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day
Eligibility criteria:
Inclusion Criteria:

Age 18-65;
DSM-IV diagnosis of BP I or BP II as per SCID;
Currently presenting with at least moderate levels of depression (HAM-D > 15;
Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate, carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as per history;
Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;

Exclusion Criteria:

Evidence of acute mania or hypomania (as measured by CARS-M > 7);
Abnormal (outside of lab normal range) thyroid function tests;
Current thyroid hormone treatment;
Any medical condition considered a contraindication for treatment with T3 (i.e. history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency, Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid antibody testing, previous or current thyroid adenoma, hyperthyroidism);
EKG showing rhythm other than sinus or repolarization phase abnormalities;
Current alcohol or substance abuse or dependence in past month as per SCID;
Score of 3 or more on the suicide item of the HAM-D;
Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.
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: 160
Group description: avanafil 50 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.