anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydrochlorothiazide
Trial phase: Phase 3
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Once daily for 3 years

12.5 mg hydrochlorothiazide: Once daily for 3 years
Eligibility criteria:
Inclusion Criteria:

Informed Consent as documented by signature
Age 18 years or older
Recurrent kidney stone disease (≥ 2 stone events within the last 10 years prior to randomization)
Any past kidney stone containing 50% or more of calcium oxalate, calcium phosphate or a mixture of both

Exclusion Criteria:

Pharmacologic prevention for stone recurrence less than 3 months prior to randomization

Patients with secondary causes of recurrent calcareous nephrolithiasis including:

Severe eating disorders (anorexia or bulimia)
Chronic inflammatory bowel disease, bariatric surgery, intestinal surgery with malabsorption or chronic diarrheal status
Sarcoidosis
Primary hyperparathyroidism
Complete distal tubular acidosis
Active malignancy

Patients with the following medications:

Thiazide or loop diuretics
Carbonic anhydrase inhibitors (including topiramate)
Xanthine oxidase inhibitors (febuxostat or allopurinol)
Alkali, including potassium citrate or sodium bicarbonate
Treatment with 1,25-OH Vitamin D (calcitriol)
Calcium supplementation
Bisphosphonates
Denosumab
Teriparatide
Glucocorticoids
Obstructive uropathy, if not treated successfully
Urinary tract infection, if not treated successfully
Chronic kidney disease (defined as CKD-EPI eGFR < 30 mL/min per 1,73 m2 body surface area for more than 3 months)
Patients with a kidney transplant
> 3 gout arthritis episodes within one year prior to randomisation or gout arthritis requiring uric acid lowering therapy
Cystinuria at screening
Hypokalemia (blood potassium level < 3 mmol/L) at screening
Hyponatremia (blood sodium level < 125 mmol/L) at screening
Pregnant and lactating women [pregnancy test to be performed for women of child-bearing potential (defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months)]
Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial
Inability to understand and follow the protocol
Known allergy to the study drug
Intervention: Hydrochlorothiazide
Trial phase: Phase 3
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Once daily for 3 years

25.0 mg hydrochlorothiazide: Once daily for 3 years
Eligibility criteria:
Inclusion Criteria:

Informed Consent as documented by signature
Age 18 years or older
Recurrent kidney stone disease (≥ 2 stone events within the last 10 years prior to randomization)
Any past kidney stone containing 50% or more of calcium oxalate, calcium phosphate or a mixture of both

Exclusion Criteria:

Pharmacologic prevention for stone recurrence less than 3 months prior to randomization

Patients with secondary causes of recurrent calcareous nephrolithiasis including:

Severe eating disorders (anorexia or bulimia)
Chronic inflammatory bowel disease, bariatric surgery, intestinal surgery with malabsorption or chronic diarrheal status
Sarcoidosis
Primary hyperparathyroidism
Complete distal tubular acidosis
Active malignancy

Patients with the following medications:

Thiazide or loop diuretics
Carbonic anhydrase inhibitors (including topiramate)
Xanthine oxidase inhibitors (febuxostat or allopurinol)
Alkali, including potassium citrate or sodium bicarbonate
Treatment with 1,25-OH Vitamin D (calcitriol)
Calcium supplementation
Bisphosphonates
Denosumab
Teriparatide
Glucocorticoids
Obstructive uropathy, if not treated successfully
Urinary tract infection, if not treated successfully
Chronic kidney disease (defined as CKD-EPI eGFR < 30 mL/min per 1,73 m2 body surface area for more than 3 months)
Patients with a kidney transplant
> 3 gout arthritis episodes within one year prior to randomisation or gout arthritis requiring uric acid lowering therapy
Cystinuria at screening
Hypokalemia (blood potassium level < 3 mmol/L) at screening
Hyponatremia (blood sodium level < 125 mmol/L) at screening
Pregnant and lactating women [pregnancy test to be performed for women of child-bearing potential (defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months)]
Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial
Inability to understand and follow the protocol
Known allergy to the study drug
Intervention: Hydrochlorothiazide
Trial phase: Phase 3
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Once daily for 3 years

50.0 mg hydrochlorothiazide: Once daily for 3 years
Eligibility criteria:
Inclusion Criteria:

Informed Consent as documented by signature
Age 18 years or older
Recurrent kidney stone disease (≥ 2 stone events within the last 10 years prior to randomization)
Any past kidney stone containing 50% or more of calcium oxalate, calcium phosphate or a mixture of both

Exclusion Criteria:

Pharmacologic prevention for stone recurrence less than 3 months prior to randomization

Patients with secondary causes of recurrent calcareous nephrolithiasis including:

Severe eating disorders (anorexia or bulimia)
Chronic inflammatory bowel disease, bariatric surgery, intestinal surgery with malabsorption or chronic diarrheal status
Sarcoidosis
Primary hyperparathyroidism
Complete distal tubular acidosis
Active malignancy

Patients with the following medications:

Thiazide or loop diuretics
Carbonic anhydrase inhibitors (including topiramate)
Xanthine oxidase inhibitors (febuxostat or allopurinol)
Alkali, including potassium citrate or sodium bicarbonate
Treatment with 1,25-OH Vitamin D (calcitriol)
Calcium supplementation
Bisphosphonates
Denosumab
Teriparatide
Glucocorticoids
Obstructive uropathy, if not treated successfully
Urinary tract infection, if not treated successfully
Chronic kidney disease (defined as CKD-EPI eGFR < 30 mL/min per 1,73 m2 body surface area for more than 3 months)
Patients with a kidney transplant
> 3 gout arthritis episodes within one year prior to randomisation or gout arthritis requiring uric acid lowering therapy
Cystinuria at screening
Hypokalemia (blood potassium level < 3 mmol/L) at screening
Hyponatremia (blood sodium level < 125 mmol/L) at screening
Pregnant and lactating women [pregnancy test to be performed for women of child-bearing potential (defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months)]
Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial
Inability to understand and follow the protocol
Known allergy to the study drug
Intervention: Hexaminolevulinate Hydrochloride
Trial phase: Not Applicable
SMILES: CCCCCCOC(=O)CCC(=O)CN.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.

Hexaminolevulinate HCL: Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor.
Planned transurethral resection of bladder tumor in the operating room.
Ability to give informed consent.
Willing to spend time for the study
Men or women (age 18 or older)
Any racial or ethnic origin

Exclusion Criteria:

Pregnancy
Nursing mother
Diagnosis of porphyria
Gross hematuria
BCG immunotherapy or intravesical chemotherapy within the past 90 days
Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid
Intervention: Cenicriviroc
Trial phase: Phase 2
SMILES: CCCCOCCOc1ccc(-c2ccc3c(c2)/C=C(/C(=O)Nc2ccc([S@@+]([O-])Cc4cncn4CCC)cc2)CCCN3CC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
Eligibility criteria:
Inclusion Criteria:

Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
Histopathological progression to cirrhosis
Model for end-stage liver disease (MELD) score ≥ 15
Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).

Exclusion Criteria:

Prior or planned liver transplantation
Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
Intervention: NIACINAMIDE
Trial phase: Phase 2
ATC code: A11HA01
SMILES: NC(=O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 1500mg twice daily: 2, 750mg tablets taken orally twice daily

Nicotinamide: Niacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet.
Eligibility criteria:
Inclusion Criteria:

Mild Cognitive Impairment (MCI) or dementia due to Alzheimer's disease (AD)

Biomarker criteria:

Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 600 pg/mL, or A ratio of total tau to Aβ42 ≥ 0.39.

Mini-Mental State Exam (MMSE) ≥ 20
Blood laboratories, urinalysis, and electrocardiogram are within normal limits or deemed clinically not significant by the site investigator
Stable medications (including approved AD therapies) for at least 4 weeks
At least 6 years of education
Able to swallow oral tablets
Speaks English fluently
Available qualified study partner (≥3 times per week in-person communication with the participant)

Exclusion Criteria:

Active neurological or psychiatric diagnosis other than AD that may affect cognition and/or function. (Obstructive sleep apnea is permitted, if treated.)
Inability to undergo lumbar puncture, including use of Coumadin, novel oral anticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily is permitted.
Hachinski ischemic scale > 4
Magnetic Resonance Imaging (MRI) incompatibility
MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter hyperintensity (Cardiovascular Health Study score 7-8+)
Diagnosis of cancer in the previous 5 years (with the exception of basal or squamous cell carcinoma)
Geriatric Depression Scale (GDS) score >6
History within the past 5 years of alcohol or substance use disorder
Laboratory evidence of a clinically significant abnormality that may interfere with study assessments
Active partial or total malabsorptive disease (e.g., celiac disease)
Resides in a skilled nursing facility
Participation in a clinical trial of a potential disease-modifying therapy for AD in previous 6-months (time between last investigational drug administration and baseline for the current study)
Pregnant, lactating or of child bearing potential (that is, women must be 2 years post-menopausal or surgically sterile to be considered not child bearing potential).
Unwillingness to abstain from over-the-counter nicotinamide for the duration of the trial
Intervention: Iodine
Trial phase: Phase 3
ATC code: D08AG03
SMILES: II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.

Iodine (Betadine)
Eligibility criteria:
Inclusion Criteria:

being over 20 years of age;
having at least one obviously cavitated tooth;
refraining from smoking, brushing the teeth and using a mouthwash the day of the bacterial sampling;
refraining from using a commercial mouth rinse during the three months of the study;
having any two of the following risk factors in the Caries Management by Risk Assessment (CAMBRA) protocol which qualifies as a high caries risk.

The high caries risk factors included:

receiving fillings within the past three years;
snacking frequently between meals;
presenting with hyposalivation due to medication, radiation or systemic conditions;
visual presence of heavy plaque accumulation;
and a minimum of 20 natural teeth.

Exclusion Criteria:

using a systemic antibiotic within the past three months;
currently receiving dental treatment or planning to receive treatment within the next three months (emergency treatment allowed);
being pregnant or nursing;
any thyroid disease or sensitivity to iodine;
the use of a commercially available mouth rinse the day of the screening examination;
smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling;
not being able to make morning examinations.
Intervention: Mepivacaine
Trial phase: Phase 4
ATC code: N01BB03 | N01BB53
SMILES: Cc1cccc(C)c1NC(=O)C1CCCCN1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.

Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Eligibility criteria:
Inclusion Criteria:

Patients ≥ 18 years of age
Planned TURBT for unilateral or bilateral posterolateral bladder tumors
Ability to understand and provide informed consent

Exclusion Criteria:

Patient refusal or inability to provide informed consent
True allergy, not sensitivity, to local anesthetics
True allergy, not sensitivity, Propofol
True allergy, not sensitivity, general anesthetic agents
Pregnancy
Severe hepatic impairment
Evidence of infection at or near the proposed needle insertion site
Any sensorimotor deficit of the lower extremity, whether acute or chronic
Inability to walk without assistance
Lower extremity joint replacement surgery in the preceding six months
Intervention: Phenazopyridine
Trial phase: Phase 3
ATC code: G04BX06
SMILES: Nc1ccc(/N=N/c2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 76
Group description: Participant is given Phenazopyridine

Phenazopyridine: Phenazopyridine on morning of postoperative day 1

76 subjects were randomized into this arm

4 were removed from the intent-to-treat analysis:

1 had a bowel injury re-operation that precluded performing a void trial
1 intraoperative cystotomy that precluded performing a void trial

2 were using Foley catheters preoperatively, which was part of the exclusion criteria

72 subjects in the intent-to-treat analysis

3 did not receive the intervention:

1 was too nauseous
1 was erroneously missed

1 refused

69 subjects in the as-treated analysis
Eligibility criteria:
Inclusion Criteria:

Women undergoing overnight admission after prolapse surgery

Exclusion Criteria:

Unable to provide consent
Under 18 years of age
Pregnant women
Prisoners
Using intermittent self-catheterization preoperatively
Neurological disease or spinal cord injury resulting in voiding dysfunction
Undergoing spinal or epidural anesthesia for the procedure
Allergy to phenazopyridine
Renal insufficiency
Liver disease
Intra-operative bladder injury necessitating use of prolonged indwelling Foley catheter
Intervention: Dronabinol
Trial phase: Phase 2
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.

Dronabinol and Palmitoylethanolamide: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult between 18-60 years of age
Meet DSM-5 criteria for the diagnosis of Tourette syndrome
Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial
Accepted method of birth control

Exclusion Criteria:

Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70)
Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
Taking any co-medications (over the counter or prescription), food supplements/additives which can have a drug interaction with dronabinol or PEA.
Positive pregnancy test or drug screening test
History of cannabis dependence
Significant Medical Comorbidity
History of hypersensitivity to any cannabinoid or sesame oil
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 254
Group description: Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 milligrams (mg), orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. One participant randomized to Placebo who was dosed with Sotagliflozin 400 mg treatment during the study is included in the Sotagliflozin 400 mg arm in the safety population.
Eligibility criteria:
Inclusion criteria :

Participants with T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
Signed written informed consent.

Exclusion criteria:

At the time of screening, age <18 years or < legal age of majority, whichever is greater.
Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening.
Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
Women of childbearing potential with no effective contraceptive method.
Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
History of severe hypoglycemia within 6 months prior to the Screening visit.
Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency.
Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN).
Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
Pregnancy, breastfeeding.
Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.