anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lovaza
Trial phase: Phase 4
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: 4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day
Eligibility criteria:
Inclusion Criteria:

Female or male patients, 18-75 years of age.
Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl
Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months

Exclusion Criteria:

Current use of triglyceride or cholesterol-lowering medication other than a statin
Current use of omega-3 fatty acid supplement
Intake of fish more than twice per week
Currently pregnant, or breastfeeding
Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)
Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).
Consumption of alcohol greater than two drinks per day or active substance abuse
Any medical condition that would make participation in the study unsafe, as determined by investigator
Intervention: Dapsone
Trial phase: Phase 4
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Dapsone Gel 5% and Tazarotene Cream 0.1%
Eligibility criteria:
Inclusion Criteria:

Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications
Intervention: Tazarotene
Trial phase: Phase 4
ATC code: D05AX05 | D05AX55
SMILES: CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Tazarotene Cream 0.1%
Eligibility criteria:
Inclusion Criteria:

Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications
Intervention: Butenafine Hydrochloride
Trial phase: Phase 1
SMILES: CN(Cc1ccc(C(C)(C)C)cc1)Cc1cccc2ccccc12.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 221
Group description: Lotrimin Ultra (butenafine) applied for 7 days
Eligibility criteria:
Inclusion Criteria:

Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.

Exclusion Criteria:

Use of any of the following within the indicated timeline:
Oral or injectable steroids
Any oral anti-fungals within 4 weeks of the study start
Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
Use of any antihistamines within 72 hours of the study start.
Any known hypersensitivity to butenafine or other antifungal agents.
Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Intervention: Lente
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(CC3C=NC=N3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC3C=NC=N3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C.[Zn]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
Eligibility criteria:
Inclusion Criteria:

Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
Less than 24 weeks at study enrollment
Singleton or twin pregnancy
English or Spanish speaking
Able to give informed consent

Exclusion Criteria:

End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
Prior need for insulin for glycemic control
History of diabetic ketoacidosis (DKA) or hyperosmolar state
Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
Kidney or liver disease
Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
Eligibility criteria:
Inclusion Criteria:

currently smoking at least 15 cigarettes daily
in good health
able to read and speak English fluently
have a home telephone and plan to reside in Western New York for 6 months
willing to make quit attempt
signed informed consent
who planned quit attempt.

Exclusion Criteria:

serious medical condition
depression or mental health condition requiring treatment in the past year
history of panic disorder, psychosis, bipolar disorder
alcohol or drug abuse in the past year
use of tobacco products other than cigarettes
current use of other cessation pharmacotherapies
pregnancy/planned pregnancy.
Intervention: Lovenox
Trial phase: Not Applicable
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Eligibility criteria:
There are two Study Sections: A and B

--------------------------------------------

Study Section A Inclusion Criteria:

acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 6 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning)
patient not a candidate for rTPA treatment because treatment cannot be started within the required 3 hours after stroke onset, or because rTPA treatment is refused.

Study Section A Exclusion Criteria:

intracranial hemorrhage;
subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
history of hypersensitivity or intolerance to or toxicity from enoxaparin, other heparinoids, heparin, minocycline, or other tetracyclines;
weight 125lbs or less;
active bleeding;
thrombolytic treatment or major surgery in the previous 24 hours;
anticipated need for treatment with coumarin, or a low-molecular weight heparin other than enoxaparin, or unfractionated heparin before 36 hours after stroke onset (but see deep venous thrombosis prophylaxis, below);
INR above the normal range;
known coagulopathy;
platelet count <100,000/mm3 (if the count drops below 100,000 while on enoxaparin, the medication will be stopped)
pregnancy or lactation;
undergoing dialysis; severe renal impairment (creatinine clearance known or estimated to be <30ml/min);
mean arterial BP (taken to be 1/3 of the difference in mm Hg between diastolic BP and systolic BP, added to the diastolic BP) of 130 mm Hg or greater; (if the mean arterial BP is 130 mm Hg or greater but can be reduced by treatment to < 130 mm Hg, with systolic BP in the 150 169 mm Hg range, the patient may be entered).

Patients in Study Section A will be randomly assigned to one of the four treatment arms: enoxaparin, minocycline, enoxaparin and minocycline, or no intervention.

--------------------------------------------

Study Section B Inclusion Criteria:

acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 24 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning;)
patient does not qualify for, or declines to participate in, Study Section A.

Study Section B Exclusion Criteria:

acute primary intracranial hemorrhage;
subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
pregnancy or lactation.

Patients in Study Section B will be randomly assigned to one of TWO treatment arms: minocycline, or no intervention.
Intervention: Minocycline
Trial phase: Not Applicable
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Minocycline 200 mg orally once daily for 5 days

Minocycline: 200 mg orally once daily for 5 days
Eligibility criteria:
There are two Study Sections: A and B

--------------------------------------------

Study Section A Inclusion Criteria:

acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 6 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning)
patient not a candidate for rTPA treatment because treatment cannot be started within the required 3 hours after stroke onset, or because rTPA treatment is refused.

Study Section A Exclusion Criteria:

intracranial hemorrhage;
subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
history of hypersensitivity or intolerance to or toxicity from enoxaparin, other heparinoids, heparin, minocycline, or other tetracyclines;
weight 125lbs or less;
active bleeding;
thrombolytic treatment or major surgery in the previous 24 hours;
anticipated need for treatment with coumarin, or a low-molecular weight heparin other than enoxaparin, or unfractionated heparin before 36 hours after stroke onset (but see deep venous thrombosis prophylaxis, below);
INR above the normal range;
known coagulopathy;
platelet count <100,000/mm3 (if the count drops below 100,000 while on enoxaparin, the medication will be stopped)
pregnancy or lactation;
undergoing dialysis; severe renal impairment (creatinine clearance known or estimated to be <30ml/min);
mean arterial BP (taken to be 1/3 of the difference in mm Hg between diastolic BP and systolic BP, added to the diastolic BP) of 130 mm Hg or greater; (if the mean arterial BP is 130 mm Hg or greater but can be reduced by treatment to < 130 mm Hg, with systolic BP in the 150 169 mm Hg range, the patient may be entered).

Patients in Study Section A will be randomly assigned to one of the four treatment arms: enoxaparin, minocycline, enoxaparin and minocycline, or no intervention.

--------------------------------------------

Study Section B Inclusion Criteria:

acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 24 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning;)
patient does not qualify for, or declines to participate in, Study Section A.

Study Section B Exclusion Criteria:

acute primary intracranial hemorrhage;
subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
pregnancy or lactation.

Patients in Study Section B will be randomly assigned to one of TWO treatment arms: minocycline, or no intervention.
Intervention: Epigallocatechin Gallate
Trial phase: Phase 1
SMILES: O=C(O[C@@H]1Cc2c(O)cc(O)cc2O[C@@H]1c1cc(O)c(O)c(O)c1)c1cc(O)c(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of MS by McDonald criteria
Relapsing-remitting MS or secondary progressive MS
Stable therapy with Copaxone, for at least six months prior to inclusion in the study or no therapy for six months in subjects refusing therapy.
EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)
Ages 18-60.
Leukocytes ≥3,000/µL
Absolute neutrophil count ≥1,500/µL
Platelets ≥100,000/µL
Total bilirubin ≤local upper limit of normal
normal AST (SGOT) ALT (SGPT)
normal serum Creatinine
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Ability to understand and the willingness to sign a written informed consent document.
Willing to drink at most one cup of black tea and two cups of coffee per day, and abstain from drinking green tea or taking supplements containing green tea or green tea compounds, for the duration of the investigation.

Exclusion Criteria:

MS relapse within the 30 days prior to enrollment.
A primary progressive form of MS.
Previous treatment prior to study entry as follows: complete radiation ablation of the bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone, cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or immunosuppressant therapies except for Copaxone or methylprednisone for relapses within prior nine months.
History of renal or liver disease.
Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment.
Participants may not participate in any other clinical trial involving investigational agents during the study, or within six months prior to enrolling in the study.
history of allergic reactions attributed to compounds of similar chemical or biologic composition to Polyphenon E, tea, or any of the inactive ingredients present in the active or placebo capsules, including gelatin.
history of allergic reactions to gadolinium or any other condition contraindicated for MRI.
Uncontrolled, clinically-relevant active illness (aside from MS) including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
Inability to complete the baseline MRI scan.
Pregnant or breastfeeding women.
Intervention: Prednisone
Trial phase: Phase 2 | Phase 3
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of PMR by standard criteria. The Bird criteria will be used. 3 or more features are required to make the diagnosis.

Bilateral shoulder pain/stiffness
Duration of symptoms <2/52
Initial ESR >40 mm/h
Stiffness >1 h
Age >65 years
Depression and/or weight loss
Bilateral upper arm tenderness
Are over 50 but less than 85 years old.
No or stable NSAID or analgesic therapy for at least 7 days.
Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one hour or PV >1.72

Exclusion Criteria:

Currently on oral glucocorticoid treatment or taken within 2 months
Parenteral glucocorticoid treatment with the last 2 months
Pregnancy and lactation
Inflammatory diseases such as inflammatory bowel disease, colitis, asthma
Co-existent giant cell arteritis
Other auto-immune diseases
Cancer
Infections, treatment with antibiotics within the past 6 weeks
Significant renal disease (creatinine >150 μmol/L)
Significant hepatic impairment
Participation in a clinical trial within the past 30 days
Working shift employee
Jet lag
Intervention: Prednisolone
Trial phase: Phase 2 | Phase 3
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of PMR by standard criteria. The Bird criteria will be used. 3 or more features are required to make the diagnosis.

Bilateral shoulder pain/stiffness
Duration of symptoms <2/52
Initial ESR >40 mm/h
Stiffness >1 h
Age >65 years
Depression and/or weight loss
Bilateral upper arm tenderness
Are over 50 but less than 85 years old.
No or stable NSAID or analgesic therapy for at least 7 days.
Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one hour or PV >1.72

Exclusion Criteria:

Currently on oral glucocorticoid treatment or taken within 2 months
Parenteral glucocorticoid treatment with the last 2 months
Pregnancy and lactation
Inflammatory diseases such as inflammatory bowel disease, colitis, asthma
Co-existent giant cell arteritis
Other auto-immune diseases
Cancer
Infections, treatment with antibiotics within the past 6 weeks
Significant renal disease (creatinine >150 μmol/L)
Significant hepatic impairment
Participation in a clinical trial within the past 30 days
Working shift employee
Jet lag
Intervention: Estradiol
Trial phase: Phase 4
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: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Group A received the oral estradiol for 12 months
Eligibility criteria:
Inclusion Criteria:

Girls with Turner Syndrome (45X, or related karyotypes) diagnosed clinically and cytogenetically
Female subjects with Y material will be allowed providing gonadectomies have been performed previously
Age: 13-20 years
Subjects have completed or nearly completed their linear growth
Previous growth hormone (GH) therapy discontinued at least 6 months prior to study participation
Stable thyroid replacement therapy will be allowed
Celiac disease on stable diets will be allowed
Any previous hormone replacement therapy (HRT) will be allowed

Exclusion Criteria:

Diabetes Mellitus on insulin therapy, insulin sensitizers or oral hypoglycemics
Inflammatory Bowel Disease (ulcerative colitis or Crohn's disease), celiac disease
Cigarette smoking
Any other chronic conditions, that, in the opinion of investigators could impair the metabolism of nutrients
Severe obesity, i.e., Body Mass Index (BMI) >95th centile