anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: A continuous intravenous infusion of lidocaine

Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
Patients with Chronic uncontrolled neuropathic pain with documented pain score > or = 4 despite opioids
Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
Having baseline/screening EKG

Exclusion Criteria:

Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
Hepatic dysfunction as determined by history and physical or clinical significant lab.
Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
Subject has inability to understand and cooperate with study procedures or provide informed consent.
Subject has history of intolerance or allergic reaction to lidocaine.
Subject has history of seizures.
Raynaud's disease
Renal impairment as determined by clinically significant labs.

Women of childbearing age who either have:

A positive pregnancy test
Unprotected heterosexual sex since their previous menses or;
Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: A continuous intravenous infusion of saline

Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
Patients with Chronic uncontrolled neuropathic pain with documented pain score > or = 4 despite opioids
Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
Having baseline/screening EKG

Exclusion Criteria:

Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
Hepatic dysfunction as determined by history and physical or clinical significant lab.
Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
Subject has inability to understand and cooperate with study procedures or provide informed consent.
Subject has history of intolerance or allergic reaction to lidocaine.
Subject has history of seizures.
Raynaud's disease
Renal impairment as determined by clinically significant labs.

Women of childbearing age who either have:

A positive pregnancy test
Unprotected heterosexual sex since their previous menses or;
Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).
Intervention: Dalfampridine
Trial phase: Phase 3
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 316
Group description: Prolonged-release fampridine 10 mg BID for up to 24 weeks
Eligibility criteria:
Key Inclusion Criteria:

Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration
Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
Must have walking impairment, as deemed by the Investigator

Key Exclusion Criteria:

History of human immunodeficiency virus (HIV)
Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
Creatinine clearance (CrCl) of <80 mL/min
History of malignant disease
Presence of pulmonary disease
A body mass index (BMI) ≥40 (BMI formula: BMI = mass [kg]/[height(m)]2)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL
HCV genotype 2
Chronic HCV infection (≥ 6 months)
Females of childbearing potential must have a negative serum pregnancy test
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.

Exclusion Criteria:

Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
Screening electrocardiogram (ECG) with clinically significant abnormalities
Laboratory results outside of acceptable ranges at Screening
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Intervention: Bryostatin 1
Trial phase: Phase 1 | Phase 2
SMILES: CCCC=CC=CC(=O)OC1C(=CC(=O)OC)CC2CC(C(C)O)OC(=O)CC(O)CC3CC(OC(C)=O)C(C)(C)C(O)(CC4CC(=CC(=O)OC)CC(C=CC(C)(C)C1(O)O2)O4)O3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour

Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
Eligibility criteria:
Inclusion Criteria:

Male or female, age 50 - 85 yrs. Females are non-childbearing potential
Patient must have a cognitive deficit present for at least 1 year and meet diagnostic criteria for probable Alzheimer's Disease Dementia by NIA-AA criteria or prodromal Alzheimer's Disease
Mini Mental State Exam score of 16-26
Ability to walk, at least with an assistive device
Vision and hearing sufficient to comply with testing
Normal cognitive and social functioning prior to onset of dementia, with evidence of progressive symptoms from patient or informant
Consistent caregiver to accompany patient to visits
Sufficient basic education to be able to complete the cognitive assessments
Living outside an institution

Exclusion Criteria:

Dementia due to any condition other than AD, including vascular dementia
Significant neuroimaging abnormalities, previously known or discovered on screening MRI scan,
Evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months
Use of any drug within 14 days prior to randomization unless the dose of the drug and the condition being treated have been stable for at least 30 days and are expected to remain stable during the study
Use of tobacco products or nicotine-containing products within 3 months before Day 1
Use of high dose vitamin E, or valproic acid
Any medical or psychiatric condition that may require medication or surgical treatment during the study
Life expectancy less than 6 months
Use of an investigational drug within 2 months prior to the screening visit
Clinically significant neurological disease other than AD
Major depression, alcohol or drug dependence or suicidality
Psychotic episodes requiring hospitalization or antipsychotic therapy for more than 2 weeks within the past 10 years, not linked to AD
Agitation sufficient to preclude participation in this trial
Epilepsy or anti-epileptic drug therapy
Abnormal laboratory tests that might point to another etiology for dementia;
Acute or poorly controlled medical illness
Likelihood, according to clinical judgment, of being transferred to a nursing home within 6 months
Intervention: Bupivacaine
Trial phase: Phase 4
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: 206
Group description: Surgical site infiltration of 0.25% bupivacaine.

Bupivacaine
Eligibility criteria:
Inclusion Criteria:

At least 18-years-old, undergoing laparoscopic urologic surgery.

Exclusion Criteria:

Pregnant and/or nursing mothers.
Allergy to bupivacaine.
Intervention: Bupivacaine
Trial phase: Phase 4
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: 206
Group description: Surgical site infiltration of liposomal bupivacaine.

liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

At least 18-years-old, undergoing laparoscopic urologic surgery.

Exclusion Criteria:

Pregnant and/or nursing mothers.
Allergy to bupivacaine.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
Eligibility criteria:
Inclusion Criteria:

Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide informed consent and to participate in all 3 periods of the study.
BMI < 35 kg/m2.

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
Eligibility criteria:
Inclusion Criteria:

Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide informed consent and to participate in all 3 periods of the study.
BMI < 35 kg/m2.

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
Eligibility criteria:
Inclusion Criteria:

Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide informed consent and to participate in all 3 periods of the study.
BMI < 35 kg/m2.

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
Eligibility criteria:
Inclusion Criteria:

Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide informed consent and to participate in all 3 periods of the study.
BMI < 35 kg/m2.

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
Eligibility criteria:
Inclusion Criteria:

Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide informed consent and to participate in all 3 periods of the study.
BMI < 35 kg/m2.

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.
Intervention: Dabigatran
Trial phase: Phase 2
SMILES: Cn1c(CNc2ccc(C(=N)N)cc2)nc2cc(C(=O)N(CCC(=O)O)c3ccccn3)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Eligibility criteria:
Inclusion criteria:

Neonates and infants with aged < 12 months at Visit 1
Objective diagnosis of VTE
End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.
Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.

Exclusion criteria:

Weight less than 3 kg at Visit 1
Conditions associated with an increased risk of bleeding
renal dysfunction
hepatic disease
Anemia or thrombocytopenia at screening
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Ciprofloxacin:

Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.

Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis.
Eligibility criteria:
Inclusion Criteria:

Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given in either Dr. Fan's clinic using povidone-iodine and post-injection topical ciprofloxacin 0.3% 4x daily for 3 days, or in Dr. Rauser's clinic where povidone-iodine only is applied to the injection site and conjunctival fornix but no post-injection antibiotics are given.

Exclusion Criteria:

Administration of anti-VEGF agents outside of Dr. Fan's or Dr. Rauser's clinics
Intraocular surgery
Use of topical antibiotics other than ciprofloxacin 0.3%
Infections of the eye or ocular adnexa within the last 3 months
Use of oral antibiotics within the last 30 days
Contact lens wear.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
Eligibility criteria:
Inclusion Criteria:

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total knee replacement.
No focal neurologic deficit of the surgical lower extremity.
Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
Body mass index (BMI) > 40 kg/m2
Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

Major systemic medical problems such as:

Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
Impaired cognitive function or inability to understand the study protocol
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
Previous contralateral knee replacement managed with regional or periarticular injection
Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)