anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Maraviroc
Trial phase: Phase 4
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.

Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet.
Eligibility criteria:
Inclusion Criteria:

HIV Positive
On HAART, with plasma viral load < 50 copies/ml for previous 12 months or more
Able to provide informed consent
HAND diagnosis, with symptom progression within previous 6 months

Exclusion Criteria:

Non-HIV related neurological disorders and active central nervous system (CNS) opportunistic infection (as assessed by full blood count, electrolytes, creatinine, glucose, liver funciton tests, cryptococcal antigen, venereal disease research laboratory (VDRL), MRI brain scan and CSF analysis for cell count, protein, glucose, culture, VDRL and cryptococcal antigen)
Psychiatric disorders on the psychiatric axis
Current major depression
Current substance use disorder, or severe substance use disorder within 12 months of study entry
Active Hepatitis C Virus (HCV) (detectable HCV RNA)
History of loss of consciousness > 1 hour
Non-proficient in English
Medications known to pharmacologically interact with antiretrovirals (ARVs)
Currently taking an entry inhibitor
Pregnancy (as assessed by the urine pregnancy test)
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT

Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
Eligibility criteria:
Inclusion Criteria:

Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
Age 18 years or older
ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
Ability to provide written informed consent • Capable of complying with study protocol

Exclusion Criteria:

History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
Intraocular injection of steroid medication within prior 4 months
Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
Previous laser photocoagulation within 4 months of study
Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
Patients who are pregnant.
Unwilling or unable to follow or comply with all study related procedures.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks

Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Eligibility criteria:
Inclusion Criteria:

Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
Age 18 years or older
ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
Ability to provide written informed consent • Capable of complying with study protocol

Exclusion Criteria:

History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
Intraocular injection of steroid medication within prior 4 months
Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
Previous laser photocoagulation within 4 months of study
Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
Patients who are pregnant.
Unwilling or unable to follow or comply with all study related procedures.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization

Intravenous fluid: 0.9% Sodium chloride intravenous fluid
Eligibility criteria:
Inclusion Criteria:

Emergency department patient with suspected or confirmed infection as primary reason for admission
Serum venous lactate 2.0 - 3.9 mmol/L
Hospital admission planned

Exclusion Criteria:

Age < 18 years
Pregnancy
Serum lactate ≥ 4.0 mmol/L
Any vasopressor or inotrope requirement
Mechanical ventilation or non-invasive positive pressure ventilation
Chronic end-stage renal disease requiring hemodialysis
Pulmonary edema as diagnosed by the primary care team
Requirement for surgery within the treatment protocol timeframe
Inability to obtain informed consent from subject or surrogate
Patient to receive comfort measures only
Intervention: Sitagliptin
Trial phase: Phase 4
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: 24
Group description: Sitagliptin response patients
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetic patients with less than 15 yrs of disease duration
BMI between 22-27 kg/m2

HbA1c ≤ 9% at recruitment

Study group

After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy

Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or

Increase of HbA1c over 1% within 2-3 months without abrupt increase of blood glucose levels within several days

Sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or glibenclamide 10mg
Metformin dose : 500~2000mg
Reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely.

2. Control group

Age, sex, BMI matched patients with same condition of study patients
After change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea therapy, no change of blood glucose levels like above or stable HbA1c change within 1% within 2-3 months

Exclusion Criteria:

Other causes of increase of blood glucose levels except drug change
Patients with history of insulin treatment
Patients taking thiazolidinediones, alpha-glucosidase inhibitors, GLP-1 analogue or DPP-4 inhibitors
Patients with renal, hepatic dysfunction
Patients with diabetic complications such as coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy or diabetic gastroparesis
Patients taking medications affecting glucose level
Intervention: Nitrofurantoin
Trial phase: Phase 4
ATC code: J01XE01 | J01XE51
SMILES: O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
Eligibility criteria:
Inclusion Criteria:

Undergoing urogynecologic surgery
Receive postoperative catheterization

Exclusion Criteria:

Age less than 21 years old
Pregnancy
Allergy, contraindication or intolerance to Nitrofurantoin
Do not speak English
Dependent on trans-urethral catheter to accomplish voiding preoperatively
Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
Sustain intraoperative urinary tract injury requiring postoperative catheterization
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Rocuronium dose 0 mg/kg
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.

Proellex: vaginal suppository, daily, for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound.
Normal transvaginal ultrasound (other than for presence of fibroids)
History of menstrual events occurring in regular cycles
Agreement not to attempt to become pregnant
Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit
Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits.

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6 month study period
Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months.
Has an IUD in place
Women currently using narcotics
Women currently taking spironolactone
Infectious disease screen is positive for HIV or Hepatitis A, B or C
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks

Proellex: vaginal suppository, daily, for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound.
Normal transvaginal ultrasound (other than for presence of fibroids)
History of menstrual events occurring in regular cycles
Agreement not to attempt to become pregnant
Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit
Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits.

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6 month study period
Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months.
Has an IUD in place
Women currently using narcotics
Women currently taking spironolactone
Infectious disease screen is positive for HIV or Hepatitis A, B or C
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks

Proellex: vaginal suppository, daily, for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound.
Normal transvaginal ultrasound (other than for presence of fibroids)
History of menstrual events occurring in regular cycles
Agreement not to attempt to become pregnant
Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit
Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits.

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6 month study period
Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months.
Has an IUD in place
Women currently using narcotics
Women currently taking spironolactone
Infectious disease screen is positive for HIV or Hepatitis A, B or C
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).

Duloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week
Eligibility criteria:
Inclusion Criteria:

premenopausal adult women, aged 18-50
Have chronic pelvic pain, as defined by the American College of Obstetrics and Gynecology
Able to read and speak English

Exclusion Criteria:

Chronic Pelvic Pain (CPP) only presenting in low back or vulva, or only present during menstruation or vaginal intercourse
Self-report or documentation that all CPP sites were attributed by a prior physician to Irritable Bowel Syndromd (IBS), Interstitial cystitis (IC)/painful bladder syndrome (PBS), urinary tract infection, urinary stones, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cancer or shingles.
Currently pregnant or lactating
A primary psychiatric diagnosis of major depression or history of suicide attempt as assessed by medical history. Also, those who would be considered to have Major Depressive Disorder (MDD) on the basis of the Diagnostic and Statistical Manual IV (DSM-IV) criteria will excluded, as well as those selecting "3" or "4" on item #9 of the Beck Depression Inventory (BDI; suicidal ideation).
A history of bipolar disorder
A history of seizure disorders
Orthostatic Hypertension

Exclusions based on the effects of duloxetine:

Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;
Treatment with an monoamine oxidase inhibitor (MAOI) within 14 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug;
Treatment with cytochrome P450 enzyme inhibitors;
Uncontrolled narrow-angle glaucoma;
Concurrent use of thioridazine
Renal Impairment (serum creatinine of 1.5 or greater)
History of jaundice or hepatomegaly
Hepatic Insufficiency (elevated aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, or Alkaline Phosphatase), tested at the screening period, after the first week of study medication, and again at the midpoint of the study.
Participants who are taking Selective serotonin reuptake inhibitors (SSRIs), Selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), monoamine oxidase inhibitors (MAOIs), or tricyclics within 14 days of randomization will be excluded.
Participants who currently meet DSM-IV diagnostic criteria for Alcohol Abuse or Dependence
Weight exceeding 285 pounds
Hyponatremia, as determined by blood test results
Intervention: Epigallocatechin Gallate
Trial phase: Phase 2
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
Healthy volunteers: No
Participants at risk: 6
Group description: Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.

Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of MS by McDonald criteria
Relapsing-remitting MS or secondary progressive MS
Stable therapy with Copaxone, Rebif, Betaseron or Avonex 30 mcg for at least six months
EDSS Score less than or equal to 7.0
Ages 18-60.

Participants must have normal organ and marrow function as defined below:

Leukocytes ≥3,000/µL
Absolute neutrophil count ≥1,500/µL
Platelets ≥100,000/µL
Total bilirubin ≤local upper limit of normal
AST (SGOT) ≤local upper limit of normal
ALT (SGPT) ≤local upper limit of normal
Creatinine ≤local upper limit of normal

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, Natalizumab or other immunomodulatory or immunosuppressant therapies except the DMT's included in the inclusion criteria and 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 women
Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, diverticulitis, colitis, hemorrhoids)