anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tolperisone
Trial phase: Phase 2
ATC code: M02AX06 | M03BX04
SMILES: Cc1ccc(C(=O)C(C)CN2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: TID (600 mg/day)

Tolperisone: TID
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
Pain localized below the neck and above the inferior gluteal folds.
Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
Chronic pain for the previous 3 months or longer, on more days than not.
Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
Concomitant severe pain in a region other than the back.
Spinal surgery within 1 year of study entry.
Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
Subjects who test positive for alcohol by breathalyzer test.
Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.

Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
Eligibility criteria:
Inclusion Criteria:

Men scheduled for surgical sperm retrieval for infertility
Men 18 years and older who can provide informed consent
No documented allergy to bupivacaine or celecoxib

Exclusion Criteria:

Prior history of substance abuse
Any narcotic use within the last 3 months
Concomitant use of aspirin
Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 3
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 485
Group description: Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Eligibility criteria:
Inclusion Criteria:

Male, age >= 18.
Histopathologically proven prostate adenocarcinoma.

Concern for metastatic disease in one of the following settings:

Initial staging with intermediate to high risk prostate cancer.
Biochemical recurrence after initial therapy.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Intervention: Pilocarpine Hydrochloride
Trial phase: Phase 3
SMILES: CCC1C(=O)OCC1Cc1cncn1C.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Eligibility criteria:
Inclusion Criteria:

- Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria:

History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
Diagnosis of any type of glaucoma or ocular hypertension
Intervention: Vibegron
Trial phase: Phase 2
ATC code: G04BD15
SMILES: [H][C@]1([C@H](O)c2ccccc2)CC[C@@H](Cc2ccc(NC(=O)[C@@H]3CCc4nccc(=O)n43)cc2)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Exclusion Criteria:

Diagnosis of IBS-C or IBS-U per Rome IV criteria
History of chronic idiopathic constipation or functional constipation
Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
Planned gastrointestinal or abdominal surgery within the next 6 months
Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)
Intervention: Tranexamic acid
Trial phase: Phase 1 | Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).

Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
Eligibility criteria:
Inclusion Criteria:

Patients must have a confirmed diagnosis of hematologic malignancy or solid tumor malignancy
Patients must be undergoing or planned chemotherapy or BMT
Patients will only be eligible to receive study drug or placebo during inpatient periods
Patients must be predicted to have thrombocytopenia ≤20,000/microliter (uL) for ≥5 days
Patient must have a platelet transfusion threshold of ≤30,000/uL
Patients must be >14 days beyond their last dose of Pegylated(PEG)-Asparaginase or >72 hours beyond their last dose of Erwinia Asparaginase
Patients must be able to comply with treatment and monitoring

Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia (APL)
History of Immune Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS)
Diagnosis of Disseminated Intravascular Coagulopathy (DIC)
History of inherited or acquired bleeding disorder AND/OR inherited or acquired prothrombotic disorder
Patient must not have WHO Grade 2 bleeding or greater within 48 hours prior to enrollment or study drug activation
Patient must not have received PEG-Asparaginase within the 7 day period prior to enrollment. If given within the 8-14 day period prior to enrollment patients are eligible if prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR) and fibrinogen are obtained and are within 1.5 times the upper limits of normal.
Patient must not be receiving tranexamic acid or other anti-fibrinolytic agent or any other agent to promote hemostasis (which includes DDAVP, recombinant Factor VII, Prothrombin Complex Concentrate, Estrogen Derivatives and Progestins)
Patient must not be receiving therapy with anticoagulation or antiplatelet therapy (which includes heparin infusion, enoxaparin, aspirin. If anticoagulant/antiplatelet therapy is discontinued when platelet count is <50,000/uL patient will be eligible for enrollment)
Patient must not be receiving platelet growth factors
Current thromboembolic event
History of thromboembolic event <6 months prior to enrollment
Current/prior history of sinusoidal obstruction disease
Visible hematuria
Renal dysfunction (as defined by age-specific creatinine values calculated by Schwartz equation) or hemodialysis or anuria (defined as <10 mL urine/hour over 24 hours)
History of seizures
Allergy to tranexamic acid
Pregnancy
Unwilling to accept blood product transfusions
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.

Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
Eligibility criteria:
Inclusion Criteria:

Patients must have a confirmed diagnosis of hematologic malignancy or solid tumor malignancy
Patients must be undergoing or planned chemotherapy or BMT
Patients will only be eligible to receive study drug or placebo during inpatient periods
Patients must be predicted to have thrombocytopenia ≤20,000/microliter (uL) for ≥5 days
Patient must have a platelet transfusion threshold of ≤30,000/uL
Patients must be >14 days beyond their last dose of Pegylated(PEG)-Asparaginase or >72 hours beyond their last dose of Erwinia Asparaginase
Patients must be able to comply with treatment and monitoring

Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia (APL)
History of Immune Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS)
Diagnosis of Disseminated Intravascular Coagulopathy (DIC)
History of inherited or acquired bleeding disorder AND/OR inherited or acquired prothrombotic disorder
Patient must not have WHO Grade 2 bleeding or greater within 48 hours prior to enrollment or study drug activation
Patient must not have received PEG-Asparaginase within the 7 day period prior to enrollment. If given within the 8-14 day period prior to enrollment patients are eligible if prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR) and fibrinogen are obtained and are within 1.5 times the upper limits of normal.
Patient must not be receiving tranexamic acid or other anti-fibrinolytic agent or any other agent to promote hemostasis (which includes DDAVP, recombinant Factor VII, Prothrombin Complex Concentrate, Estrogen Derivatives and Progestins)
Patient must not be receiving therapy with anticoagulation or antiplatelet therapy (which includes heparin infusion, enoxaparin, aspirin. If anticoagulant/antiplatelet therapy is discontinued when platelet count is <50,000/uL patient will be eligible for enrollment)
Patient must not be receiving platelet growth factors
Current thromboembolic event
History of thromboembolic event <6 months prior to enrollment
Current/prior history of sinusoidal obstruction disease
Visible hematuria
Renal dysfunction (as defined by age-specific creatinine values calculated by Schwartz equation) or hemodialysis or anuria (defined as <10 mL urine/hour over 24 hours)
History of seizures
Allergy to tranexamic acid
Pregnancy
Unwilling to accept blood product transfusions
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.

Transdermal Lidocaine Patch: Transdermal Lidocaine Patch
Eligibility criteria:
Inclusion Criteria:

Maternal age greater than or equal to 18
Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at delivery if no prepregnancy/ early pregnancy weight available
Singleton or multifetal pregnancy
Able to receive neuraxial analgesia
Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate time to consider and consent to the study
Gestational age greater or equal to 32 weeks

Exclusion Criteria:

Known hypersensitivity to lidocaine or colloid patch (defined as a history of a reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or hydrocolloid patch reported by patient or documented in the medical record) or patient report
Contraindication to regional analgesia
Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.
Current opioid use or opioid use disorder per patient report or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)
Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for >3 months
Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)
Planned vertical midline incision
Presence of renal dysfunction precluding the use of NSAIDs
Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy
Coagulopathy
Planned discharge from the hospital less than 24 hours postpartum
Intervention: Amphetamine
Trial phase: Phase 1
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 93
Group description: Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.

d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule
Eligibility criteria:
Inclusion Criteria:

Aged 18-19 years old
BMI of 19-26
Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
at least High School education
Fluent in English

Exclusion Criteria:

No Current Mood, Anxiety, Eating or Psychotic Disorder
No current psychotropic medication
No Recent Drug Dependence
< 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly average)
No weekly (or more frequent) illicit drug use
No women who are pregnant, nursing, or planning pregnancy within 3 months (birth control is okay)
Intervention: Amphetamine
Trial phase: Phase 1
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 93
Group description: Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.

d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule
Eligibility criteria:
Inclusion Criteria:

Aged 18-19 years old
BMI of 19-26
Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
at least High School education
Fluent in English

Exclusion Criteria:

No Current Mood, Anxiety, Eating or Psychotic Disorder
No current psychotropic medication
No Recent Drug Dependence
< 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly average)
No weekly (or more frequent) illicit drug use
No women who are pregnant, nursing, or planning pregnancy within 3 months (birth control is okay)
Intervention: Lumateperone
Trial phase: Phase 2
ATC code: N05AD10
SMILES: CN1CCN2c3c(cccc31)C1CN(CCCC(=O)c3ccc(F)cc3)CCC12
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Open-Label ITI-007 40-60 mg

ITI-007: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Eligibility criteria:
Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
Has capacity to provide informed consent
Medically stable for study participation
Judged clinically not to be at significant suicide or violence risk
Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

Exclusion Criteria:

Substance abuse within last 90 days
ECG abnormality that is clinically significant
Pregnancy, lactation, or lack of use of effective birth control
Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
History or presence of concomitant major psychiatric illness.
Use of other antipsychotic medications at baseline.
Use of another investigational medication in the previous 4 weeks
Intervention: Methenamine Hippurate
Trial phase: Phase 2
SMILES: C1N2CN3CN1CN(C2)C3.O=C(O)CNC(=O)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.

Methenamine Hippurate 1 g tablet: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).
Eligibility criteria:
Inclusion Criteria:

Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR via failed retrograde void trial and require an indwelling Foley catheter upon hospital discharge.

Exclusion Criteria:

Unwillingness to participate in the study
Inability to understand English
Pregnant women
Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder, chronic renal insufficiency (GFR <60 ml/min/1.73 m² or serum creatinine level >1.03 for >3months), sarcoidosis, and severe hepatic insufficiency
Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
Active urinary tract infection
Patient history of taking Warfarin (Coumadin)
Intraoperative bladder injury or cystotomy
Physical or mental impairment that would affect the subject's ability to take medications daily or fill out questionnaires
Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill
Intervention: Rifaximin
Trial phase: Phase 4
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Rifaximin 550 mg BID

Rifaximin: Rifaximin 550 MG BID
Eligibility criteria:
Inclusion Criteria:

Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of >25.

Exclusion Criteria:

Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.