anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Amphetamine
Trial phase: Phase 2
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.

NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.

Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*

Vaccinium angustifolium
Eligibility criteria:
Inclusion Criteria:

Adults 65-85 years of age (inclusive).
Able to understand and sign the informed consent.
Native English-speaking.
No evidence of dementia (MMSE >=23).
Each subject must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice.

Exclusion Criteria:

Use of high dose antioxidant supplements other than what is provided in the trial.
History of known allergy to components of the study supplements.
Mental illness judged by the PI to preclude a successful completion of the trial.
Persons who are not native English speakers are excluded from the current proposal because many of the cognitive tests that are administered are language-based and are heavily influenced by first language.
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 540
Group description: Participants who participated in primary study [SP0967 (NCT02477839) or SP0969 (NCT01921205)] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing <30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing >=30 kg to <50 kg, and LCM 300 mg/day as tablets for study participants weighing >=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
Eligibility criteria:
Inclusion Criteria:

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
Subject is expected to benefit from participation, in the opinion of the investigator
Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
Subject is male or female aged 1 month to ≤17 years
Subject has a diagnosis of epilepsy with partial-onset seizures

Exclusion Criteria:

Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: normal thermal condition with core temperatures between 36.5°C and 37°C

sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state

Reversal effect of sugammadex in temperature state
Eligibility criteria:
Inclusion Criteria:

Patient for elective abdominal surgery from 20 years (yrs) to 65 yrs Patient in American Society of Anesthesiologists criteria 1 or 2 Patient in the supine position with arm available for neuromuscular monitoring during operation

Exclusion Criteria:

Patients expected to have a difficult airway, known neuromuscular disease, significant hepatic or renal dysfunction, family history of malignant hyperthermia, known allergy to one of the drugs used in this protocol, intake of any medication that might interact with muscle relaxants, pregnant, or breast feeding
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: mild hypothermia with core temperatures between 34.5°C and 35°C

sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state

Reversal effect of sugammadex in temperature state
Eligibility criteria:
Inclusion Criteria:

Patient for elective abdominal surgery from 20 years (yrs) to 65 yrs Patient in American Society of Anesthesiologists criteria 1 or 2 Patient in the supine position with arm available for neuromuscular monitoring during operation

Exclusion Criteria:

Patients expected to have a difficult airway, known neuromuscular disease, significant hepatic or renal dysfunction, family history of malignant hyperthermia, known allergy to one of the drugs used in this protocol, intake of any medication that might interact with muscle relaxants, pregnant, or breast feeding
Intervention: Naldemedine
Trial phase: Phase 3
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 to 80 years inclusive at the time of informed consent
Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)
Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary

Exclusion Criteria:

Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
Evidence of active medical diseases affecting bowel transit
History or presence of pelvic disorders that may be a cause of constipation
Surgery (except for minor procedures) within 60 days of Screening
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)
Subjects who have never taken laxatives for the treatment of OIC
History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer
Current use of any prohibited medication including opioid antagonists, partial agonists or mixed agonists/antagonists
Intervention: Naldemedine
Trial phase: Phase 3
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 621
Group description: Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
Eligibility criteria:
Inclusion Criteria

Subjects aged 18 to 80 years inclusive at the time of informed consent
Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
Subjects may or may not be on a routine laxative regimen at the time of Screening

Exclusion Criteria

Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
Evidence of active medical diseases affecting bowel transit
History of pelvic disorders that may be a cause of constipation
Surgery (except for minor procedures) within 60 days of Screening
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical GI obstruction)
Subjects who have never taken laxatives for the treatment of OIC
Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 2
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
Eligibility criteria:
Inclusion Criteria:

DSM-IV criteria for opioid abuse and prescription opioid physical dependence
18-65 years of age
Stable weight (<10% change in 3 months) and stable physical health
Chronic pain syndrome (e.g., osteoarthritic pain or chronic lower back pain with/without history of surgery) of moderate (4-7) average daily pain of 6+ months duration; opioid medication maintenance for 6+ months
Seeking treatment for chronic pain
Must be expected to achieve a good analgesic effect from buprenorphine

Exclusion Criteria:

DSM-IV untreated Axis I disorders (e.g. MDD, BAD, psychotic disorders, eating disorders) requiring treatment
Regular consumption of more than 500 mg caffeine daily
Primary pain diagnosis of neuropathic pain, malignant pain, or headache
History of allergy, adverse reaction, or sensitivity to opioids, including buprenorphine
Pregnancy, lactation, or history of having given birth or had abortion or miscarriage within the last six months, or unwillingness to use an effective method of birth control (e.g. condoms, birth control pills, abstinence)
Psychotropic medications which would potentially interfere with study procedures
Inability to read or understand the self-report assessment forms unaided
Use of medications known to interfere with buprenorphine metabolism, such as disulfiram, neuroleptics, azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and HIV protease inhibitors (e.g. ritonavir, indivair, and saquinavir)
Methadone-dependent
Current heroin dependence
Current buprenorphine maintenance
History of failed treatment with buprenorphine maintenance for pain
Acute hepatitis with elevated liver function tests (i.e. AST and ALT > 3 times the upper limit of normal) or impaired renal function (creatinine > 1.2 )
Any medical condition that might interfere with the study or significantly increase the medical risks of study participation
Participant is currently receiving any investigational drug or has used any investigational drug within 30 days of study entry
History of significant cardiovascular disease, such as coronary artery disease or hypertension requiring more than two anti-hypertensive agents
History of insulin-dependent diabetes
Body mass index of <18.5 or > 35.0
Intervention: Bravelle
Trial phase: Phase 4
SMILES: CCC(C)C1NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CC(C)C)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(C(C)O)NC1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 352
Group description: 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)

Urofollitrophin
Eligibility criteria:
Inclusion Criteria:

Age: 18-38 years old;
BMI: 18-28 kg/m2;
Less than 3 previously completed IVF cycles;
Basal FSH <10 IU/L and E2 <80 pg/ml;
TSH < 2.5 mIU/L
>10 and <30 antral follicles 2-10 mm in size for both ovaries combined
AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)
Presence and adequate visualization of both ovaries;
Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;

Exclusion Criteria:

Primary ovarian failure or women known as poor responders;
PCO and PCOS;
Severe OHSS in a previous COH cycle;
Uterine malformation that may impair the possibility to get pregnant;
Ovarian cysts >10 mm;
Hydrosalpinx that have not been surgically removed or ligated;
Endometriosis stage 3 or 4;
Oocyte donation;
Severe male factor;
Pathologies associated with any contraindication of being pregnant;
History of recurrent miscarriage (more than 3 previous miscarriages);
Hypersensitivity to the study medication;
Abnormal bleeding of undetermined origin;
Uncontrolled thyroid or adrenal dysfunction;
Neoplasias;
Severe impairment of renal and/or hepatic function.
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge

Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge.
Eligibility criteria:
Inclusion Criteria:

Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
AND:
Cardiac Surgery
Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin

Exclusion Criteria:

use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
left ventricular assist device
percutaneous or laparoscopic surgery
end stage renal disease
end stage liver disease
history of pancreatitis
type 1 diabetes
pregnancy
unable to give consent in english
no phone
prisoners
less than 18 years of age
Intervention: Bucindolol
Trial phase: Phase 2
SMILES: CC(C)(Cc1c[nH]c2ccccc12)NCC(O)COc1ccccc1C#N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: bucindolol hydrochloride (bucindolol)

Capsules were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.

bucindolol hydrochloride
Eligibility criteria:
Key Inclusion Criteria:

Must weigh at least 40 kg
Possess the β1389 Arg/Arg genotype
Left Ventricular Ejection Fraction (LVEF) < 0.50 assessed within 12 months prior to Screening
At least one episode of symptomatic paroxysmal or persistent AF within 180 days of Screening
Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present after study drug initiation
Receiving appropriate anticoagulation therapy prior to Randomization

Key Exclusion Criteria:

NYHA Class IV symptoms at the time of Randomization
Significant fluid overload at Randomization
Permanent AF at Screening
More than two previous ECV within 6 months of Randomization or if the most recent ECV failed to produce SR
Presence of an LVAD, or likely to requirement LVAD placement within 6 months of Randomization
History of a successful atrioventricular (AV) node ablation
History of an AF/AFL ablation within 30 days of Randomization
Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD) device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90 days of Randomization
Intervention: Eplerenone
Trial phase: Phase 4
ATC code: C03DA04
SMILES: [H][C@@]12CC[C@@]3(CCC(=O)O3)[C@@]1(C)C[C@H]1O[C@@]13[C@@]2([H])[C@H](C(=O)OC)CC1=CC(=O)CC[C@@]13C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Change from baseline at time of drug initiation
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
Patient followed regularly at Washington University-affiliated institution
If female, willing to use 2 forms of contraception including one barrier method during protocol

Exclusion Criteria:

GFR <30 ml/min
Potassium >5.0 mmol/L
Unable or unwilling to comply with study protocol
Use of potassium sparing diuretics
Use of an aldosterone blocker currently or previously
Known intolerance of eplerenone or aldosterone blockade
Pregnant, breastfeeding, or actively trying to get pregnant
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).

Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
Eligibility criteria:
Inclusion Criteria:

Children older than 10, and younger than 19 years of age undergoing unilateral arthroscopic surgery of the knee
American Society of Anesthesiologists (ASA) Status I or II
Patient's parent/guardian willing and able to give consent
Patient willing to give assent

Exclusion Criteria:

Arthroscopic anterior cruciate ligament repair
Systemic steroid use within the last 3 months
Diabetes mellitus
Females testing positive for pregnancy
BMI > 98th percentile
Positive pregnancy test
Coagulopathy
Renal or hepatic disease
Pre-existing motor or sensory deficits in the lower extremities
Predisposition for falls based on pre-existing sensory or motor deficits of the legs or inability to perform crutch training.
Non-English speaking
Systemic fungal infection
Immunosuppressed patients
Intervention: Opioid
Trial phase: Not Applicable
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.CCOC(=O)C1(c2ccccc2)CCN(C)CC1.COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 88
Group description: 5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen

Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen
Eligibility criteria:
Inclusion Criteria:

We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.

Exclusion Criteria:

Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.
Intervention: Progesterone
Trial phase: Phase 2
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: In this group women will receive oral micronized progesterone twice a day.

Progesterone
Eligibility criteria:
Inclusion Criteria:

Need to be within 3 weeks of delivery because relapse to smoking happens early after childbirth
Aged 18 to 42 years
history of smoking, with smoking and other nicotine product abstinence achieved in the final two months of pregnancy and at delivery
In good health as verified by medical history
Using acceptable birth control methods other than hormonal contraceptives that contain progestins
Have biologically confirmed abstinence from tobacco and other nicotine products at randomization

Exclusion Criteria:

A history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, liver failure, or other medical conditions that the physician investigator deems will make study participation unsafe for the subject
Current or past history bipolar disorder or schizophrenia or current diagnosis of major depression, panic disorder or post-traumatic stress disorder
Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to randomization into the trial
the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
inability to speak Spanish or English (our group is bilingual)
plans to move out of the area within 8 months after study screening since this will make follow-up difficult
Inability to understand study procedures or provide informed consent
Currently undergoing treatment with another pharmacological agent for smoking cessation
pending legal case that may result in incarceration since this would force abstinence and impede follow-up;
Pending case with child protective services that might lead removal of infant from mother's custody, as this would impede breastfeeding and infant follow-up
Unwilling to accept randomization
Subsequent pregnancy since that would be another source of progesterone
An acute general medical condition that would require imminent re-hospitalization since this would enforce abstinence (women may be randomized if they are discharged and still within the recruitment window)
Allergy to progesterone or peanuts (vehicle for micronized progesterone)
Currently undergoing treatment with ketoconazole or any other known strong CYP3A4 inhibitors