anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Solifenacin
Trial phase: Not Applicable
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: patients is this arm will receive placebo

solifenacin: patient will receive solifenacin 5mg daily or placebo daily
Eligibility criteria:
Inclusion Criteria:

Women between the ages of 18 and 89
Incontinence in the form of post void dribbling that occurs at least twice weekly.

Exclusion Criteria:

Severe renal or hepatic disease.
Active urinary tract infection.
Glaucoma.
Stress incontinence as the only incontinence symptom
Urge incontinence as the only incontinence symptom
Chronic severe constipation.
History of bladder cancer.
Known or suspected hypersensitivity to anticholinergics.
Any clinical condition that would not allow safe completion of the study.
Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.
Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.
Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.
Intervention: Alcaftadine
Trial phase: Phase 4
ATC code: S01GX11
SMILES: CN1CCC(=C2c3ccccc3CCn3c(C=O)cnc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Eligibility criteria:
Inclusion Criteria:

History of eye allergies within the past 24 months
Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Exclusion Criteria:

Current eye infection
Eye surgery within 3 months or vision correction surgery within 6 months
Any planned surgery during the study or 30 days after the study
Intervention: Olopatadine
Trial phase: Phase 4
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Eligibility criteria:
Inclusion Criteria:

History of eye allergies within the past 24 months
Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Exclusion Criteria:

Current eye infection
Eye surgery within 3 months or vision correction surgery within 6 months
Any planned surgery during the study or 30 days after the study
Intervention: Pramipexole
Trial phase: Not Applicable
ATC code: N04BC05
SMILES: CCCN[C@@H]1CCc2nc(N)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients

pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Eligibility criteria:
Inclusion Criteria:

idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
De Novo
Hoehn&Yahr staging (H&Y) I-II

Exclusion Criteria:

Atypical Parkinsonism
Pregnant or breast-feeding women
those with abnormal Liver/kidney function
those participating other clinical trials within 30 days before being enrolled for this trial.
Intervention: Milnacipran
Trial phase: Phase 2
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
Eligibility criteria:
Inclusion Criteria:

Meet Rome III criteria for IBS and have no red flags.
Must have had a colonoscopy within the previous 5 years to exclude inflammatory or other bowel disease
Be fluent and literate in English
Must either be of non-childbearing potential or agree to utilize approved birth control for the duration of the study

Exclusion Criteria:

Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening.
Any other diagnosis to explain the abdominal pain,
Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or any disease that may interfere with the subject successfully completing the trial
Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >3 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL)
Has disease affecting electrolytes balance, such as SIADH with serum Sodium less than 130mmol/L
Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
Any surgery on the stomach, small intestine or colon, excluding appendectomy
A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 1 year.
History of attempted suicide or uncontrolled bipolar disorder.
Currently using antidepressants for psychiatric conditions like major depression. Use of TCA or SSRI class antidepressant acceptable if being used specifically for treatment of bowel symptoms and patient is willing to taper off the medication
Previous use of Milnacipran or other SNRI antidepressant (duloxetine, venlafaxine, desvenlafaxine)
A diagnosis of seizure disorder
A diagnosis of glaucoma
Currently taking heparin or warfarin
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: FDA approved drug used in single arm study

intranasal ketorolac: 15 mg
Eligibility criteria:
Inclusion Criteria:

Patient is being seen in the emergency department (ED) in acute pain from an acute illness or injury (such as a kidney stone or an acute musculoskeletal injury)
Age ≥ 18 years and < 65 years
Stable patient with stable vital signs, including not in shock (systolic BP >90), not in respiratory failure, and not a multiple trauma patient
Mentally competent patient is able to understand the consent form
Baseline pain score is moderate to severe (e.g. on NRS ≥ 4 on a 0 to 10 NRS or ≥ 40 on a 0 to 100 NRS)

Exclusion Criteria:

Unstable patients
Multiple trauma patients
Patients with any allergies to ketorolac or any of the components in the nasal spray preparation
Patients with active peptic ulcer disease
Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS
Patients about to undergo major surgery
Patients with renal disease or at risk for renal failure due to volume depletion
Pregnant or nursing mothers
Patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, and/or those at high-risk of bleeding
Patient with a nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)
Patient with any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
History of chronic pain
History of drug abuse
History of significant neurologic disorder (could include diseases such as diabetic neuropathy, Parkinson's disease, etc)
History of significant psychiatric disorder
History of being on medications that may affect neurotransmitters (such as certain neurologic or psychiatric medications)
No immediate post-op patients
Intervention: Vildagliptin
Trial phase: Phase 4
ATC code: A10BD08 | A10BH02
SMILES: N#C[C@@H]1CCCN1C(=O)CNC12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months

vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
Oral hypoglycemic agents treatment
Chronic foot ulcers
Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test >30 -mmHg, anklebrachial index values > 0.7 and < 1.2 with toe pressure > 30 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg
Written consensus

Exclusion Criteria:

Active Charcot disease
Ulcers resulting from electrical, chemical, or radiation burns
Collagen vascular disease
Ulcer malignancy
Untreated osteomyelitis, or cellulitis
Ulcer treatment with normothermic or hyperbaric oxygen therapy
Concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy
Recombinant or autologous growth factor products
Skin and dermal substitutes within 30 days of study start
Use of any enzymatic debridement treatments
Pregnant or nursing mothers
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
Eligibility criteria:
Inclusion Criteria:

Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
No prior therapy for breast cancer.
Age 18 years or older.
Any menopausal status
Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
Availability of tissue blocks from initial core needle biopsy.
Signed informed consent.
Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.

Exclusion Criteria:

Presence of any Metastatic lesion.
History of parathyroid disease, hypercalcemia, or kidney stones.
History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy.
Receiving metformin.
History of renal failure requiring dialysis or kidney transplantation.
Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
Any condition potentially interfering with subjects ability to comply with taking study medication.
Any medical condition that would potentially interfere with vitamin D absorption.
Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
Patients currently taking more than 2000 IU of Vitamin D.
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Obese participants receive Vitamin D at 400 or 10,000 IU/day
Eligibility criteria:
Inclusion Criteria:

Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
No prior therapy for breast cancer.
Age 18 years or older.
Any menopausal status
Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
Availability of tissue blocks from initial core needle biopsy.
Signed informed consent.
Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.

Exclusion Criteria:

Presence of any Metastatic lesion.
History of parathyroid disease, hypercalcemia, or kidney stones.
History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy.
Receiving metformin.
History of renal failure requiring dialysis or kidney transplantation.
Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
Any condition potentially interfering with subjects ability to comply with taking study medication.
Any medical condition that would potentially interfere with vitamin D absorption.
Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
Patients currently taking more than 2000 IU of Vitamin D.
Intervention: Febuxostat
Trial phase: Phase 4
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Febuxostat: 80mg PO daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).
Plasma uric acid level ≥5 mg/dl
Ages 18-50
non-smokers
Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.

Exclusion Criteria:

no current smoking in the prior 6 months.
Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.
Any history of gout, hypertension, hypercholesterolemia, morbid obesity.
Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications
any history of illicit drug use within the last 6 months
Intervention: TRIENTINE
Trial phase: Not Applicable
ATC code: A16AX12
SMILES: NCCNCCNCCN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients receive once a day trientine

Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of Wilson Disease:

That have been treated for at least 1 year
Compensated liver disease and/or stable neurological or psychiatric disease.
Normal or minimal elevation of serum ALT (<2 times upper limit of normal)
Non-ceruloplasmin copper <25 mcg/dl

Exclusion Criteria:

Wilson disease diagnosis not well established Wilson disease treated for less than one year Decompensated liver disease (ascites, jaundice, encephalopathy, bleeding due to portal hypertension) Liver disease with elevations of ALT > 2 times upper limit of normal A female who is pregnant or intends to become pregnant
Intervention: Amoxicillin clavulanate
Trial phase: Not Applicable
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C(O)C1C(=CCO)OC2CC(=O)N21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65 years (male or female)
Good general health
Able to comply with study requirements and to provide informed consent
For women of childbearing potential oA negative urine pregnancy test immediately prior to starting the study treatment oAgreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)

Exclusion Criteria:

History of organ transplantation
Known chronic or recurrent systemic disorder associated with immunocompromise
A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins
History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
Oral or systemic antibacterial therapy during the 3 months prior to study enrollment
New prescription medications during the 4 weeks prior to study enrollment
Prescription, OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
Active gastrointestinal disease
Patients with a central venous catheter
Patients taking antifungals or laxatives within 14 days of enrolment
Patients enrolled in other clinical trials within the past 60 days
Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
History of chronic constipation with passage of fewer than 3 bowel movements per week on average
Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
Intervention: Vilazodone
Trial phase: Phase 4
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 255
Group description: Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
Eligibility criteria:
Inclusion Criteria:

Men and women, 18-70 years of age.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.

Patients with a history of meeting DSM-IV-TR criteria for any:

manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
any depressive episode with psychotic or catatonic features;
panic disorder with or without agoraphobia;
obsessive-compulsive disorder;
schizophrenia, schizoaffective, or other psychotic disorder;
bulimia or anorexia nervosa;
presence of borderline personality disorder or antisocial personality disorder;
mental retardation, dementia, amnesia, or other cognitive disorders;
patients who are considered a suicide risk.
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Male or non-pregnant female patients
Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
On regularly scheduled oral loop diuretics prior to admission

Fluid overload manifested by at least two of the following:

Pitting edema (2+) of the lower extremities
Jugular venous distention > 8 cm
Pulmonary edema or pleural effusion on chest x-ray
Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
Respiration rate ≥ 20 per minute.
Have received ≤ 2 IV loop diuretics doses before randomization
Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
Provide written informed consent form as required by the local IRB (Institutional Review Board)

Exclusion Criteria:

Acute coronary syndromes
Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
Systolic blood pressure < 90 mmHg at time of enrollment
Pulmonary Arterial Hypertension not secondary to left heart disease
Contraindications to systemic anticoagulation
Hematocrit > 45%
Inability to obtain venous access
Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
Severe concomitant disease expected to prolong hospitalization
Severe concomitant disease expected to cause death in ≤ 90 days
Sepsis or ongoing systemic infection
Severe uncorrected valvular stenosis
Active myocarditis
Hypertrophic obstructive cardiomyopathy
Constrictive pericarditis or restrictive cardiomyopathy
Liver cirrhosis
Previous solid organ transplant
Requirement for mechanical ventilatory support
Presence of a mechanical circulatory support device
Unwillingness or inability to complete follow up
Active drug or ETOH substance abuse
Participating in another interventional clinical trial