anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CID 3081884
Trial phase: Phase 2
ATC code: L03AX13
SMILES: CC(=O)O.CC(N)C(=O)O.NC(CCC(=O)O)C(=O)O.NC(Cc1ccc(O)cc1)C(=O)O.NCCCCC(N)C(=O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Dose escalation:

Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.

Glatiramer Acetate
Eligibility criteria:
Inclusion Criteria:

Female patients with genetically confirmed Rett Syndrome (RTT)
Age: 10 or more years old. Selection of the age is based on the available evidence of the safety of Glatiramer Acetate (GA) in this group, and the relative homogeneity/stability of the phenotype, which is not expected to spontaneously change within a 6 month period at this age
Ambulatory (with our without support)

Exclusion Criteria:

Prolonged Qtc (obtained within 30 days prior to enrollment)
Presence of co morbid non-Rett related disease
Presence of immunodeficiency requiring intravenous immunoglobulin 3 (IVIG 3) months prior to enrollment
Allergy/sensitivity to GA or mannitol
Inability or unwillingness of legal guardians to give written informed consent
Intervention: Midodrine
Trial phase: Not Applicable
ATC code: C01CA17
SMILES: COc1ccc(OC)c(C(O)CNC(=O)CN)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.

Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session
Eligibility criteria:
Inclusion Criteria:

Patients of participating surgeons undergoing unilateral primary total hip arthroplasty
Ages 18-90
English-speaking
If the patients are diagnosed with orthostatic hypotension (fall in SBP of at least 20 mmHg or DBP of at least 10 mmHg within 3 min of assuming a sitting/standing position)

Exclusion Criteria:

Body mass index > 40
Low ejection fraction (<50%)
Clinical diagnosis of congestive heart failure
Aortic insufficiency characterized as greater than moderate
Severe uncontrolled hypertension
Symptomatic bradycardia (HR < 50 bpm and symptoms)
Creatinine > 1.2 mg/dl
Hepatic insufficiency
Severe respiratory disease in which supplemental oxygen is required
History of severe urinary retention
Use of MAO inhibitors
Severe supine hypertension (SBP >= 150 mmHg or DBP >= 90 mmHg)
History of visual problems and using fludrocortisone acetate
Contraindication for repeated BP measurements
Revision THA and additional procedures
Clonidine use
Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual.

Ropivacaine
Eligibility criteria:
Inclusion Criteria:

Patients undergoing Roux-en-Y gastric bypass surgery;
Patients who able to tolerate general anesthetic and pneumoperitoneum;
Patients who able to provide informed consent for the surgery;
Patients over the age of 18 years;

Exclusion Criteria:

Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve Gastrectomy after delivery of intraperitoneal ropivacaine will be included and analyzed using intention-to-treat approach)
Patients with an allergy to local anesthetics
Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/hr (millilitre per hour))
Patients with hepatic dysfunction Child-Pugh Class B or C
Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Modafinil 200 mg will be administered orally one time

Modafinil
Eligibility criteria:
Inclusion Criteria:

Osteoarthritis of the knee or hip
Adult (ages 18-80)
Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with normal activity)
American Society of Anesthesiologists physical status 1-3
Healthy subjects without pain

Exclusion Criteria:

Pregnancy;
Currently taking gabapentin
Currently taking a narcotic prescription medication that is > 50 mg morphine equivalents/day
Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction
History of previous eye surgery
Psychotic disorder or a recent psychiatric hospitalization
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Gabapentin 900 mg will be administered orally one time

Gabapentin
Eligibility criteria:
Inclusion Criteria:

Osteoarthritis of the knee or hip
Adult (ages 18-80)
Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with normal activity)
American Society of Anesthesiologists physical status 1-3
Healthy subjects without pain

Exclusion Criteria:

Pregnancy;
Currently taking gabapentin
Currently taking a narcotic prescription medication that is > 50 mg morphine equivalents/day
Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction
History of previous eye surgery
Psychotic disorder or a recent psychiatric hospitalization
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.

ramelteon
Eligibility criteria:
Inclusion Criteria:

At screening visit:

aged 18-65
nonsmokers
for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers

To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:

ages 18-65 inclusive;
PSQI-Component 2 (sleep latency) score of greater than 1;
non-smoker (e.g., less than 20 cigarettes in the past 5 years);
habitual bedtime between 8:30 pm and midnight

For premenopausal women:

regular menstrual cycles determined by Framingham Study criteria;
not pregnant and no history of oral contraceptive (OC) usage in last 6-months.

For postmenopausal women:

no recent (< 6 months) use of Hormone Replacement Therapy (HRT)
no surgical menopause

Exclusion Criteria:

positive urine drug screen
Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.
Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.
use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).
Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.
Intervention: Morpholinoacetonitrile
Trial phase: Phase 1
SMILES: N#CCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic plaque psoriasis for at least 6 months before screening
Greater than or equal to (>=) 10% of BSA with plaques
Psoriasis Area and Severity Index (PASI) >=12
Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
Currently having a form of non-plaque psoriasis as specified in the protocol
Drug induced psoriasis
Biological treatments as specified in the protocol, within 3 months prior to Day 1
Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1
Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol
Use of aspirin as defined in the protocol
Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1
Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol
Other protocol defined exclusion criteria could apply
Intervention: Morpholinoacetonitrile
Trial phase: Phase 1
SMILES: N#CCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic plaque psoriasis for at least 6 months before screening
Greater than or equal to (>=) 10% of BSA with plaques
Psoriasis Area and Severity Index (PASI) >=12
Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
Currently having a form of non-plaque psoriasis as specified in the protocol
Drug induced psoriasis
Biological treatments as specified in the protocol, within 3 months prior to Day 1
Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1
Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol
Use of aspirin as defined in the protocol
Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1
Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol
Other protocol defined exclusion criteria could apply
Intervention: Serine
Trial phase: Phase 2
SMILES: NC(CO)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: D-serine

D-serine: D-serine 60 mg/kg
Eligibility criteria:
Inclusion criteria:

18 to 64 years old,
IQ≥85 and
estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry.

Exclusion criteria:

history of neurological visual or hearing impairment,
active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),
current alcohol or drug abuse (<1 month) or substance dependence (<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.
Intervention: Clavulanate Potassium
Trial phase: Phase 2
SMILES: O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: The Control Group received standard dosings of intravenous Timentin plus other standard care.
Eligibility criteria:
Inclusion Criteria:

M or F subjects 18 - 90 years old
Subject has pre-existing diabetes diagnosis
Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life
Consequence of infected wound would require Std of Care share debridement
Subject willing and able to provide written informed consent
Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations
PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device

Exclusion Criteria:

Allergy to contrast media
Known bleeding disorder including thrombocytopenia
Recent AMI or elevated Troponin levels within last 30 days
Penicillin sensitivity; Timentin sensitivity
Female subjects known to be or suspected to be pregnant or lactating
Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure
Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment
The PI determines the subject is not an appropriate subject for the study
PROCEDURAL EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device
Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters
Intervention: Ovral
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2031
Group description: AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)

AG200-15: Transdermal contraceptive delivery system
Eligibility criteria:
Inclusion Criteria:

Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion Criteria:

Known or suspected pregnancy
Lactating women
Anticipates use of condoms or any other form of back-up contraception during the study
History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
Has a contraindication to combined estrogen-progestin contraceptive use
Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
Smoker who is 35 years old or over
Intervention: ASPIRIN
Trial phase: Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: 150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older
Determined to have a venous leg ulcer (clinical indications of venous ulceration, Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)
Able to tolerate compression therapy
Able to provide written informed consent
Confirmation with participant's general practitioner that the participant can take low dose aspirin or placebo.

Exclusion Criteria:

Pregnant or breast-feeding women
History of myocardial infarction, stroke, transient ischaemic attack, angina or significant peripheral arterial disease
History of adverse effects related to aspirin use
Currently using aspirin, or other anti-platelet or anticoagulant therapy
Opinion of screening medical practitioner at National Institute of Health Innovation that participant has an existing condition or treatment that is a contraindication to use of aspirin or to participation in the trial.
Intervention: Ketoprofen
Trial phase: Phase 4
ATC code: M01AE03 | M01AE17 | M01AE53 | M02AA10 | M02AA27 | N02AJ14
SMILES: CC(C(=O)O)c1cccc(C(=O)c2ccccc2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.

Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes
Eligibility criteria:
Inclusion Criteria:

patients presented with headache who diagnosed as migraine attack according to the international headache society

Exclusion Criteria:

denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
Intervention: Ertapenem
Trial phase: Phase 2
ATC code: J01DH03
SMILES: [H][C@@]1(SC2=C(C(=O)O)N3C(=O)[C@]([H])([C@@H](C)O)[C@@]3([H])[C@H]2C)CN[C@]([H])(C(=O)Nc2cccc(C(=O)O)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Eligibility criteria:
Inclusion Criteria:

Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015
Diagnosed with end stage renal disease and requires hemodialysis three times a week
No allergy to β lactam medications
Existing IV access for parenteral ertapenem infusion
Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post.
No evidence of hepatic disease
No history of alcoholism or drug abuse within pervious 2 years
Not pregnant

Exclusion Criteria:

History of any form of epilepsy, seizure or convulsion
Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states
Currently taking probenecid
Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study
Currently receiving any antimicrobial agents for prophylaxis or treatment
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.

Normal Saline: Dispensed in a 5 cc syringe
Eligibility criteria:
Inclusion Criteria:

Males and females 18 years or older of all races and backgrounds
Competent to give informed consent
Meet the Rome III diagnostic criteria for functional constipation
Inability to relax the puborectalis muscle at electromyography
Altomare Obstructed Defecation Syndrome score of 15 points or above

Failure of treatment with 2 conservative measures which may be as follows:

1 laxative (osmotic or stimulant) for 2 weeks
1 fiber supplement for one month
And/or trial of biofeedback for at least 4 sessions

Exclusion Criteria:

Previous treatment with Botox (possible antibodies)
Known hypersensitivity to any of the components of the toxin
Medication regimen includes narcotics
Previous radiation therapy to the anal canal and rectum
Prior proctectomy
Presence of unhealed and symptomatic anal fissure
Presence of anal pain
Presence of fecal incontinence
Presence of full thickness rectal prolapse
Presence of internal sphincter myopathy
Inflammatory bowel disease or proctitis
Pregnancy or breast-feeding
Subject is currently enrolled/ just finished participating in a clinical trial in which the intervention/ its carry-over effect may interact with the intervention in this trial
Intervention: SECRETIN
Trial phase: Phase 2 | Phase 3
ATC code: V04CK01
SMILES: CC(C)C[C@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(=O)N[C@H](C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Stimulate pancreatic secretion

Secretin: Drug to stimulate pancreatic secretion
Eligibility criteria:
Inclusion Criteria:

Scheduled for pancreatic surgery requiring pancreatic resection at DHMC
Age greater than 18 years old
Ability to provide written informed consent

Exclusion Criteria:

Inability to provide written informed consent
Current ongoing acute pancreatitis
Pregnant or nursing mothers
Any medical condition which in the judgment of the Investigator renders participation in this study medically inadvisable.
Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: One drop of olopatadine in each eye on Days 1 and 15.
Eligibility criteria:
Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

Presence of active eye infection (bacterial, viral, or fungal)
History of an eye herpetic infection.