anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of type 1 or 2 diabetes mellitus
Diagnosis of macular edema
Visual acuity between 20/200 to 20/40

Exclusion Criteria:

Eye surgery to the study eye within 3 months
Use of Ozurdex® within 9 months
Any active ocular inflammation and infection
Diagnosis of glaucoma
Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
Intervention: Healon
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Sodium hyaluronate ophthalmic solution 0.1%
Eligibility criteria:
Inclusion Criteria:

Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

Active ocular infection
Vernal keratoconjunctivitis
Recurrent corneal erosion
Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
Anticipated use of contact lens during the study.
Insertion of punctal plug or fall out of punctal plug within 3 months
Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
Receipt of any investigational product within 4 months.
Intervention: Prostaglandin
Trial phase: Phase 2
SMILES: CCCCCC(C=CC1C=CC(=O)C1CC=CCCCC(=O)OC)OC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: One drop at 8.00pm.
Eligibility criteria:
Inclusion Criteria:

Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

Any ocular hypertension other than chronic open angle glaucoma
Intervention: SODIUM CHLORIDE
Trial phase: Early Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: In this crossover study, all participants received all 5 treatments, including placebo.
Eligibility criteria:
Inclusion criteria: 1) Female and male smokers, aged 18 to30 years, who have been smoking for at least a year, and a life-time consumption of at least 100 cigarettes; 2) smoke more frequently than once a week and ≤5 cpd; 3) FTND score <3 indicating no or minimal evidence for nicotine dependence; 4) urine cotinine levels >100 ng/mL indicating smoking status and a level <1000 mg/mL consistent with nicotine intake of LITS; 5) not seeking treatment at the time of the study for nicotine dependence; 6) in good health as verified by medical history, screening examination, and screening laboratory tests; 7) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion criteria: 1) history of major medical illnesses that the physician investigator deems as contraindicated for the subject to be in the study; 2) requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) or psychiatric diagnosis and treatment for psychiatric disorders including major depression, bipolar disorder, schizophrenia in the past 6 months; and 3) current dependence to alcohol or any other recreational or prescription drugs and; 4) daily use of smokeless tobacco products or exclusive daily use of e-cigarettes (non-daily users will be included).
Intervention: Naproxen Sodium
Trial phase: Phase 3
SMILES: COc1ccc2cc(C(C)C(=O)[O-])ccc2c1.[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
Eligibility criteria:
Inclusion Criteria:

Healthy, ambulatory, male and female volunteers ages 12 and older

Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:

one full bony impaction
two partial bony impactions
one full bony impaction and one partial bony impaction
one full bony impaction and one soft tissue impaction
one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
Current or past history of bleeding disorder(s)
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
Positive alcohol breathalyzer test and positive urine drug test prior to surgery
Females who are pregnant or lactating
Chronic or severe sleep problems that do not respond to Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
Habitually spends less than 6.5 hours in bed
Intervention: Phenytoin
Trial phase: Phase 3
ATC code: N03AB02 | N03AB52
SMILES: O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Eligibility criteria:
Inclusion Criteria:

Healthy, ambulatory, male and female volunteers ages 12 and older

Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:

one full bony impaction
two partial bony impactions
one full bony impaction and one partial bony impaction
one full bony impaction and one soft tissue impaction
one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
Current or past history of bleeding disorder(s)
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
Positive alcohol breathalyzer test and positive urine drug test prior to surgery
Females who are pregnant or lactating
Chronic or severe sleep problems that do not respond to Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
Habitually spends less than 6.5 hours in bed
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Titration of gabapentin to effect

Sham epidural steroid injection: Injection of saline into the back muscles

Gabapentin: Titration of gabapentin to effect
Eligibility criteria:
Inclusion Criteria:

Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain)
MRI evidence of spinal pathology consistent with symptoms

Exclusion Criteria:

Untreated coagulopathy
Previous spine surgery
No MRI study
Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.

Pregnancy
Intervention: Olanzapine
Trial phase: Not Applicable
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
Eligibility criteria:
Inclusion Criteria:

Healthy Volunteer
Male
Aged 18-35 years
Body Mass Index (BMI): <30 kg/m2

Exclusion Criteria:

Presence of any medical disorder that may confound the assessment of relevant biological measures
Intervention: Clindamycin
Trial phase: Not Applicable
ATC code: D10AF01 | D10AF51 | G01AA10 | J01FF01
SMILES: [H][C@]1([C@]([H])(NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@H](SC)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 53
Group description: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Eligibility criteria:
Inclusion Criteria:

Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.

Exclusion Criteria:

Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
Children with surgical site infections will be excluded.
Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
Patients allergic or intolerant to both bactrim and clindamycin will be excluded.
Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.
Intervention: Oxcarbazepine
Trial phase: Phase 4
ATC code: N03AF02
SMILES: NC(=O)N1c2ccccc2CC(=O)c2ccccc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 174
Group description: Oxcarbazepine twice a day treatment Group

150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
Eligibility criteria:
Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria:

Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
Subject taking any immunosuppressant within 28 days prior to Visit 1
Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
Subject has a history of status epilepticus within last 3-month period prior to Visit 1
Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
Body weight is lower than 40 kg (< 40 kg)
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 402
Group description: Lantus SC injection once daily for 12 months on top of mealtime insulin.
Eligibility criteria:
Inclusion criteria :

Participants with type 2 diabetes mellitus

Substudy inclusion criteria:

Completion of the 6-month study period in main study (Visit 10)
Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

Age less than (<) 18 years
HbA1c <7.0% or greater than (>) 10% at screening
Diabetes other than type 2 diabetes mellitus
Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
Any contraindication to use of insulin glargine as defined in the national product label
Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
Use of an insulin pump in the last 6 months before screening visit
Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
Pregnant or breast-feeding women or women who intend to become pregnant during the study period

Substudy exclusion criteria:

Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 406
Group description: Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
Eligibility criteria:
Inclusion criteria :

Participants with type 2 diabetes mellitus

Substudy inclusion criteria:

Completion of the 6-month study period in main study (Visit 10)
Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)

Exclusion criteria:

Age less than (<) 18 years
HbA1c <7.0% or greater than (>) 10% at screening
Diabetes other than type 2 diabetes mellitus
Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
Participants using sulfonylurea in the last 2 months before screening visit
Any contraindication to use of insulin glargine as defined in the national product label
Use of insulin pump in the last 6 months before screening
Initiation of new glucose-lowering medications in the last 3 months before screening visit
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
Pregnant or breast-feeding women or women who intend to become pregnant during the study period

Substudy exclusion criteria:

Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.