anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 1
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: 16
Group description: Marcaine 0.25% infiltration (bupivacaine HCl 175 mg).

Marcaine 0.25% infiltration: Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration
Eligibility criteria:
Inclusion Criteria:

To be eligible for inclusion into the study, subjects must:

Be a man or woman ≥18 years of age.
Be eligible for unilateral inguinal hernioplasty with mesh (open laparotomy, tension-free technique) performed according to standard surgical technique under general anesthesia. Repair of multiple hernias through a single incision is permitted. If female of childbearing potential, have a negative pregnancy test at screening and before randomization on Day 1 AND be using an effective contraception method (ie, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, OR be surgically sterile, OR be a postmenopausal female (no menses for at least 1 year or hysterectomy).
Has the ability and willingness to comply with the study procedures.
Be willing to use only permitted medications throughout the study.
Be willing to use opioid analgesia.
Be able to fluently speak and understand either English or Spanish and be able to provide meaningful written informed consent for the study.

Exclusion Criteria:

A subject will be excluded from study participation if prior to surgery he/she:

Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen, or bovine products.
Is scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedure.
Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within the 30 day postoperative period.
Has known or suspected history of alcohol or drug abuse or misuse within 3 years of screening or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.
Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff or otherwise contraindicate study participation.
Has venous access difficulties that may preclude the frequent pharmacokinetic sampling requirements of the study.
Has participated in a clinical trial (investigational or marketed product) within 30 days of surgery.
Intervention: SULFUR HEXAFLUORIDE
Trial phase: Phase 4
ATC code: V08DA05
SMILES: FS(F)(F)(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent.

Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.

Sulfur Hexafluoride: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.

Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Eligibility criteria:
Inclusion Criteria:

- Crohn's disease patients with involvement of terminal ileum (thickness > 3mm).

Exclusion Criteria:

Patients with change of medicine or going to surgery over the 6-months follow-up period.
Patients with unreliable ultrasound images due to conditions such as large body habitus or poor ultrasound imaging window.
Adults lacking capacity to consent.
Vulnerable subjects such as prisoners.
Pregnant women and nursing mothers.
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
Patients with history of hypersensitivity allergic reactions to ultrasound contrast agents.
Intervention: Naloxegol
Trial phase: Phase 4
ATC code: A06AH03
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2[C@@H](OCCOCCOCCOCCOCCOCCOCCOC)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

Naloxegol 25 MG: Oral Naloxegol 25 MG
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Female or male aged at least 18 years
American Society of Anesthesiologists physical status 1-4;
Scheduled for elective primary hip or knee surgery under spinal anesthesia;
Expected to receive intravenous patient-controlled analgesia (IV PCA)
Expected to have significant postoperative pain
Negative pregnancy test

Exclusion Criteria:

Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
Severe renal impairment, or creatinine level > 2.0
History of bladder cancer
Patients receiving perioperative regional anesthesia blocks
Presence of a sacral nerve stimulator
Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
Patients with known or suspected disruption of blood brain barrier, which may include but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and Parkinson's disease
Gastrointestinal obstruction/Gastrointestinal perforation
Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
Intervention: Epicatechin
Trial phase: Phase 2
SMILES: Oc1cc(O)c2c(c1)OC(c1ccc(O)c(O)c1)C(O)C2
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: (-)-epicatechin 50mg twice per day (100mg per day total dose)

(-)-Epicatechin
Eligibility criteria:
Inclusion Criteria:

Prior participation in UCD0113 BMD epicatechin pilot study
Male
Age 18 years to 70 years
Average to low daily physical activity
Ability to ambulate for 75 meters without assistive devices
Diagnosis of BMD confirmed by at least one the following:
Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or
Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or
Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or
Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD.
Hematology profile within normal range
Baseline laboratory safety chemistry profile within normal range
No plan to change exercise regimen during study participation
Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable).

Exclusion Criteria:

Currently enrolled in another treatment clinical trial.
History of significant concomitant illness or significant impairment of renal or hepatic function.
Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.
Regular participation in vigorous exercise.
Symptomatic heart failure with cardiac ejection fraction <25%
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Ferric carboxymaltose, administered IV
Eligibility criteria:
Inclusion criteria include:

Subjects having IDA caused by different aetiologies
Haemoglobin (Hb) ≤ 11 g/dL
Body weight > 50 kg
Serum ferritin (S-ferritin) < 100 ng/mL
Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
Serum phosphate (S-phosphate) > 2.5 mg/dL
Intolerance or unresponsiveness to oral iron
Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion criteria include:

Acute bleeding > 500 mL within 72 hours
Anaemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compounds
Treatment with IV iron within the last 30 days prior to screening
Treatment with erythropoietin or erythropoietin-stimulation agents
Red blood cell transfusion, radiotherapy, and/or chemotherapy
Received an investigational drug within the last 30 days prior to screening
Planned surgical procedure within the trial period
Hepatic enzymes > 3 times upper limit of normal
Surgery under anaesthetic within the last 30 days prior to screening
Any non-viral infection within the last 30 days prior to screening
Alcohol or drug abuse within the past 6 months
Vitamin D deficiency
Untreated hyperparathyroidism
Kidney transplantation
Active malignant disease, disease-free for less than 5 years
History of a psychological illness or seizures
Pregnant or nursing women.
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 3
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Bupivacaine HCl without epinephrine, 75 mg by injection.

173 = Safety Population because 1 subject was randomized to HTX-011, but received bupivacaine HCl.
Eligibility criteria:
Inclusion Criteria:

Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
Has an American Society of Anesthesiologists Physical Status of I, II, or III.
Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

Had any prior inguinal hernia repair.
Has a planned concurrent surgical procedure.
Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Has taken NSAIDs within 10 days prior to the scheduled surgery.
Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
Has been administered bupivacaine within 5 days prior to the scheduled surgery.
Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
Has undergone 3 or more surgeries within 12 months.
Has a body mass index (BMI) >39 kg/m2.
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Ferric carboxymaltose, administered IV
Eligibility criteria:
Inclusion Criteria include:

Subjects diagnosed with IDA, caused by different aetiologies
Haemoglobin (Hb) ≤ 11 g/dL
Body weight > 50 kg
Serum ferritin (S-ferritin) < 100 ng/mL
Estimated glomerular filtration rate (eGFR) ≥ 65 mL/min/1.73 m2
Serum phosphate (S-phosphate) > 2.5 mg/dL
Intolerance or unresponsiveness to oral iron
Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

Acute bleeding > 500 mL within 72 hours
Anaemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compounds
Treatment with IV iron within the last 30 days prior to screening
Treatment with erythropoietin or erythropoietin-stimulation agents
Red blood cell transfusion, radiotherapy, and/or chemotherapy
Received an investigational drug within the last 30 days prior to screening
Planned surgical procedure within the trial period
Hepatic enzymes > 3 times upper limit of normal
Surgery under anaesthetic within the last 30 days prior to screening
Any non-viral infection within the last 30 days prior to screening
Alcohol or drug abuse within the past 6 months
Vitamin D deficiency
Untreated hyperparathyroidism
Kidney transplantation
Active malignant disease, disease-free for less than 5 years
History of a psychological illness or seizures
Pregnant or nursing women.
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 40 IU intranasal oxytocin spray

Oxytocin: 40 IU oxytocin nasal spray, self-administered
Eligibility criteria:
Inclusion Criteria:

Male or female; any race or ethnicity; age 18-75 years.
Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
Participants must be able to comprehend English.
Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS).
A CAPS score of 50 or greater.
Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social phobia, generalized anxiety disorder). The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. Initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.

Exclusion Criteria:

Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically.
Participants who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those participants will be referred clinically.
Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months.
Pregnant women will be excluded from the proposed study.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 24 mg/day for 4 weeks

Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting
Eligibility criteria:
Inclusion Criteria:

Patients must be medically healthy, between 18 and 60 years of age
Fluent (speaking and writing) in English
Patients must have a current diagnosis of obsessive-compulsive disorder (OCD) or tic disorder (OCD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria with moderate or greater disorder severity and moderate or greater severity of sensory phenomena
Patients must be unmedicated or taking antidepressants, stable for at least 6 weeks

Exclusion Criteria:

Present or previous diagnosis of any psychosis, bipolar disorder, or major developmental disorder (autism/Asperger's disorder, pervasive developmental disorder). Present diagnosis of alcohol or substance use disorder (moderate or severe) will also be exclusionary.
Any disability or health problem that prevents them from completing study procedures (e.g. color blindness, severe carpal tunnel syndrome, etc.).
History of organic mental syndromes, head trauma, migraines, seizures, other central nervous system (CNS) neurological disease, or significant medical illness other than that listed above.
Pregnant or nursing women will be excluded.
Subjects with a medical condition or other predisposition that increases the risk of adverse effects when taking ondansetron. These include, but are not limited to, individuals with drug allergies or known hypersensitivity to ondansetron (or other 5-HT3 antagonists), heart disease, congestive heart failure, heart rhythm disorder, congenital long QT syndrome, electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia) or hepatic impairment.
Subjects who report taking apomorphine will be excluded.
Subjects with abnormal EKG will either be excluded from participation, or referred to a cardiologist for further assessment of eligibility.
Subjects with abnormal liver function or electrolytes (as determined by blood test) will be excluded from participation if a study team physician determines it is unsafe for them to participate.
Cross-reactivity with other 5-HT3 antagonists has been reported, so any individual taking a 5-HT3 antagonist will be excluded.
Intervention: Estradiol
Trial phase: Phase 4
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

50mcg estradiol cream: Use of study drug nightly
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women aged 40 to 70 years old.

Postmenopausal, demonstrated by at least one of the following:

i. Cessation of menses for ≥1 years if age is >50 ii. Bilateral oophorectomy iii. A history of climacteric symptoms if below age 50, having an ovary and scarred or absent uterus.

Onset of dyspareunia after menopause.*
Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
No estrogen product use, local or systemic, for 6 months.*
More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).*
Willingness to enter a study where she will receive low-dose local estrogen.*
Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. *

Willingness to evaluate the progress of therapies by use of the Tampon Test as many as 2 times per week, and willingness to attempt intercourse if the Tampon Test indicates tolerable penetrative pain.*

n/a for reference group

Exclusion Criteria:

Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.
Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.
Constant burning pain localized to the vulva.
Allergy to local estrogen products or lidocaine numbing agents.
Previous estrogen receptor positive breast cancer or endometrial cancer.
Endometrial thickness ≥5mm on screening via transvaginal ultrasound.