anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Mirtazapine
Trial phase: Phase 2
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.

Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Eligibility criteria:
Inclusion Criteria:

DSM-IV-TR diagnosis of current alcohol dependence, confirmed by the Mini International Neuropsychiatric Interview (MINI)
DSM-IV-TR diagnosis of current major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

Any person who meets criteria for alcohol-induced depression
Any psychotic disorder bipolar disorder, mental retardation, impaired cognitive functioning, or use of any psychotropic medication in the previous month
Current Diagnostic and Statistical Manual (DSM-IV) criteria for dependence on substances other than alcohol, cannabis, nicotine, or caffeine
Significant neurological conditions or medical conditions
Persistent elevation of liver function enzymes indicating active liver disease (elevated t. bilirubin or elevation to three-time normal range of liver enzymes, SGOT, SGPT, or g-GTP)
The presence of renal function impairment defined as serum creatinine >2x upper limit of normal
Pregnancy, inability or unwillingness to use contraceptive methods
Use of any antidepressant medication in the prior two months, or any lifetime use of mirtazapine
Inability to read or understand study forms and agree to informed consent
Intervention: Ciprofloxacin
Trial phase: Not Applicable
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 120
Group description: This group received antibiotic therapy

Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group
Eligibility criteria:
Inclusion Criteria:

CD138 immunohistochemical staining of endometrial specimen showed presence of one or more plasma cells per 10HPF which confirmed chronic endometritis, according to published criteria.
women who were pre-menopausal.
no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.
agreement to have a second endometrial biopsy ~4 weeks after the initial endometrial biopsy.
written informed consent obtained

Exclusion Criteria:

women who received steroid hormone therapy within one month of recruitment.
allergy or suspected allergy to the chosen antibiotic therapy.
women who developed any concurrent infection and received any antibiotic therapy during the period of study other than the one prescribed according to the study protocol.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic hepatitis C virus (HCV) infection
Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
Subject must be HCV treatment-naïve or have failed previous HCV treatment.
Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.

Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent
Scheduled for open abdominal surgery
American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

Inability to understand the study or provide written informed consent
Inability to follow protocol instructions
Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
Allergy to local anesthetic agents
Contraindication to regional nerve block such as:
Bleeding disorder
Sepsis
Infection at site of block
Body Mass Index (BMI) >40
Pregnancy
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane

Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent
Scheduled for open abdominal surgery
American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

Inability to understand the study or provide written informed consent
Inability to follow protocol instructions
Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
Allergy to local anesthetic agents
Contraindication to regional nerve block such as:
Bleeding disorder
Sepsis
Infection at site of block
Body Mass Index (BMI) >40
Pregnancy
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump

Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent
Scheduled for open abdominal surgery
American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

Inability to understand the study or provide written informed consent
Inability to follow protocol instructions
Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
Allergy to local anesthetic agents
Contraindication to regional nerve block such as:
Bleeding disorder
Sepsis
Infection at site of block
Body Mass Index (BMI) >40
Pregnancy
Intervention: Methylprednisolone
Trial phase: Phase 4
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
Eligibility criteria:
Inclusion Criteria:

Primary idiopathic CTS
Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)
Failed treatment with wrist splinting (2 months)
Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis
Symptom severity that warranted referral for consideration for surgery

Exclusion Criteria:

Previous steroid injection for CTS
Thenar muscle atrophy
Sensory deficit (two-point discrimination >8 mm)
Diabetes, thyroid disorder, or inflammatory disease
Polyneuropathy or vibration-induced neuropathy
Current pregnancy
Previous carpal tunnel surgery on the study hand
Surgery on the contralateral hand in the past 2 months
Inability to respond to questionnaires
Severe medical illness
Known drug/alcohol abuse
Intervention: Methylprednisolone
Trial phase: Phase 4
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
Eligibility criteria:
Inclusion Criteria:

Primary idiopathic CTS
Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)
Failed treatment with wrist splinting (2 months)
Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis
Symptom severity that warranted referral for consideration for surgery

Exclusion Criteria:

Previous steroid injection for CTS
Thenar muscle atrophy
Sensory deficit (two-point discrimination >8 mm)
Diabetes, thyroid disorder, or inflammatory disease
Polyneuropathy or vibration-induced neuropathy
Current pregnancy
Previous carpal tunnel surgery on the study hand
Surgery on the contralateral hand in the past 2 months
Inability to respond to questionnaires
Severe medical illness
Known drug/alcohol abuse
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 105
Group description: In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)

Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Eligibility criteria:
Inclusion Criteria :

ASA 1 and 2
18-60 years old
Patients scheduled for ambulatory arthroscopic or open surgery

Exclusion Criteria:

ASA 3 and 4
Pre-existing pain disorder
Regular consumption of chronic pain medication
Anatomical abnormalities of upper extremity
Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
Known allergy to dexmedetomidine
Coagulopathy
Uncontrolled Diabetes
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: Dapagliflozin 10 mg daily

Dapagliflozin
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
No change in diuretic management for at least 1 week prior to enrollment
Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment

Exclusion Criteria:

History of type 1 diabetes
Estimated glomerular filtration rate (eGFR) < 30 at enrollment
Hospitalization for heart failure within the 30 days prior to enrollment
Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment
Patients who are volume depleted based upon physical examination at the time of screening or randomization
Intervention: Potassium magnesium citrate (2:1:3)
Trial phase: Phase 4
SMILES: O=C([O-])CC(O)(CC(=O)O)C(=O)O.O=C([O-])CC(O)(CC(=O)O)C(=O)O.O=C([O-])CC(O)(CC(=O)[O-])C(=O)O.[K+].[K+].[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks

Potassium magnesium Citrate (KMgCit)
Eligibility criteria:
Inclusion Criteria:

Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
Age > 21 years of age

Exclusion Criteria:

Diabetes mellitus,
Renal impairment (serum creatinine > 1.4 mg/dL),
Any heart diseases such as congestive heart failure or sustained arrhythmia,
Chronic NSAID use,
Treatment with diuretics,
Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
Esophageal-gastric ulcer,
Chronic diarrhea
Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)
Liver function test above upper limit of normal range.
Subjects who require any potassium supplement on a regular basis from any reasons
Pregnancy
History of major depression, bipolar disorder, or schizophrenia
History of substance abuse.
Intervention: Potassium Citrate
Trial phase: Phase 4
ATC code: A12BA02
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[K+].[K+].[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.

Potassium citrate powder
Eligibility criteria:
Inclusion Criteria:

Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
Age > 21 years of age

Exclusion Criteria:

Diabetes mellitus,
Renal impairment (serum creatinine > 1.4 mg/dL),
Any heart diseases such as congestive heart failure or sustained arrhythmia,
Chronic NSAID use,
Treatment with diuretics,
Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
Esophageal-gastric ulcer,
Chronic diarrhea
Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)
Liver function test above upper limit of normal range.
Subjects who require any potassium supplement on a regular basis from any reasons
Pregnancy
History of major depression, bipolar disorder, or schizophrenia
History of substance abuse.
Intervention: POTASSIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12BA01 | A12BA51 | B05XA01
SMILES: [Cl-].[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks

Potassium chloride powder
Eligibility criteria:
Inclusion Criteria:

Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
Age > 21 years of age

Exclusion Criteria:

Diabetes mellitus,
Renal impairment (serum creatinine > 1.4 mg/dL),
Any heart diseases such as congestive heart failure or sustained arrhythmia,
Chronic NSAID use,
Treatment with diuretics,
Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
Esophageal-gastric ulcer,
Chronic diarrhea
Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)
Liver function test above upper limit of normal range.
Subjects who require any potassium supplement on a regular basis from any reasons
Pregnancy
History of major depression, bipolar disorder, or schizophrenia
History of substance abuse.
Intervention: Darinaparsin
Trial phase: Phase 2
SMILES: C[As](C)SC[C@H](NC(=O)CC[C@H](N)C(=O)O)C(=O)NCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Eligibility criteria:
Inclusion Criteria:

Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
Patients aged ≥20 years on the date of informed consent

Patients with histologically confirmed diagnosis of one of the following:

Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
Angioimmunoblastic T-cell Lymphoma (AITL)
Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)
Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
Have at least 1 measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with a life expectancy of at least 3 months as determined by the investigator
Intervention: OBETICHOLIC ACID
Trial phase: Not Applicable
ATC code: A05AA04
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCC(=O)O)[C@@]1(C)CC[C@]1([H])[C@@]3(C)CC[C@@H](O)C[C@@]3([H])[C@@H](CC)[C@@H](O)[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.

10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Individuals ≥ 21 to 65 years old
Able to provide informed consent & negative urine pregnancy test where appropriate
Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
Women of child bearing potential should be willing to practice contraception throughout the treatment period

Exclusion Criteria:

Active infection as evidenced by positive urine culture, blood culture, or pneumonia
Serum creatinine > 1.5 mg/dL
Known co-existing infection with hepatitis C, hepatitis B, or HIV
Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
Total bilirubin > 2 mg/dl and INR > 1.5 Page 20 of 37
Women who are pregnant or nursing
Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
Subjects who are taking warfarin