anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 254
Group description: Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.

Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
Eligibility criteria:
Inclusion Criteria:

Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.

Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis.
Eligibility criteria:
Inclusion Criteria:

Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.

Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
Eligibility criteria:
Inclusion Criteria:

Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Growth hormone
Trial phase: Phase 1
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
Eligibility criteria:
Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years
Cystic fibrosis, diagnosed by either sweat chloride or genetic testing
Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men
Moderate or better pulmonary function (Forced Expiratory Volume (FEV1) >40% of predicted).
Agree to use an effective method of birth control to prevent pregnancy during the research study.

Women should not nurse (breast feed) a baby while on this study because Nutropin AQ may enter breast milk and possibly harm the child.

Exclusion Criteria:

Pregnancy (positive pregnancy test) prior enrollment in the study
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Participation in another simultaneous medical investigation or trial
Pediatric patients
Active neoplasm
History of organ transplantation
Prader Willi Syndrome who are severely obese or have severe respiratory impairment
Patients with hepatic impairment resulting in abnormal coagulation studies (>1.5 times normal reference range)
Poorly controlled diabetes as determined by a Hemoglobin A1c greater than or equal to 9.0%.
Individuals with electrocardiogram abnormality or cardiac pacing.
Intervention: Duloxetine
Trial phase: Phase 3
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: 60 to 120 mg, capsules, oral, once a day for 15 weeks
Eligibility criteria:
Inclusion Criteria:

Psychiatric Diagnosis of generalized anxiety disorder (GAD)
Outpatients
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
Clinical Global Impression (CGI) of Severity Score of at least moderate
Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

Exclusion Criteria:

Pregnancy or breast feeding
Serious medical illness
Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
lifetime history of bipolar or psychosis
Any unstable serious medical condition for which duloxetine would not be allowed
Any use of medications that are not allowed
Intervention: Alprazolam
Trial phase: Phase 4
ATC code: N05BA12
SMILES: Cc1nnc2n1-c1ccc(Cl)cc1C(c1ccccc1)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Pacients receiving only alprazolam
Eligibility criteria:
Inclusion Criteria:

Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/14. (Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).

Exclusion Criteria:

A history of some kind of recent somatic disease.
Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
Hamilton Anxiety Scale lower than 20 points or higher than 30.
Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
Patients who could not complete the clinical examination
Patients who have not accepted to complete or sign the written informed consent.
Pregnant patients or in lactation. (A pregnancy test was performed for women in fertile age)
Patients with history of rejection to the used drug.
Intervention: Doxycycline
Trial phase: Phase 4
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Oral doxycycline

doxycycline: Oral doxycycline 100mg bid
Eligibility criteria:
Inclusion Criteria:

Meibomian gland dysfunction

Exclusion Criteria:

Lid margin scarring; herpetic blepharitis
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Topical azithromycin daily to the conjunctival culdesac

azithromycin: topical 1% azithromycin daily to eye
Eligibility criteria:
Inclusion Criteria:

Meibomian gland dysfunction

Exclusion Criteria:

Lid margin scarring; herpetic blepharitis
Intervention: VALACYCLOVIR
Trial phase: Not Applicable
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 103
Group description: Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

19 years or older
HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
Documented HIV-1 seropositive
Currently receiving HAART for 3 months or longer
CD4 (cluster of differentiation 4) count 350 or greater
Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD (intrauterine device), diaphragm or cervical cap.
Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed

Exclusion Criteria:

History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.
Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.
Medical history of seizures
Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
AST (aspartate aminotransferase) or ALT (alanine aminotransferase) over 5 times uper limit of normal
History of thrombotic microangiopathy
For women, pregnancy as confirmed by a urine or serum pregnancy test.
Any other condition which, in the opinion of the principal investigator, may compromise the subject's ability to follow study procedures and complete the study.
Participants with active bacterial STDs (sexually transmitted diseases) may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.
Intervention: Oseltamivir Phosphate
Trial phase: Phase 3
SMILES: CCOC(=O)C1=CC(OC(CC)CC)C(NC(C)=O)C(N)C1.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 336
Group description: oseltamivir phosphate oral capsules
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction
Intervention: Clevidipine
Trial phase: Phase 3
ATC code: C08CA16
SMILES: CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1cccc(Cl)c1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales
Baseline systolic blood pressure (immediately prior to initiation of study drug) of ≥160 mm Hg
Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)
Required IV antihypertensive therapy to lower blood pressure
Written informed consent

Exclusion Criteria:

Administration of an agent (IV or oral) for the treatment of elevated BP within the previous 2 hours of randomization. (Previous short-acting non-IV nitrates, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) were permitted)
Chest pain and/or electrocardiogram with ST segment changes consistent with acute coronary syndrome
Known or suspected aortic dissection
Acute myocardial infarction within the prior 14 days
Dialysis-dependant renal failure
Requirement for immediate endotracheal intubation
Positive pregnancy test, known pregnancy or breast feeding female
Intolerance or allergy to calcium channel blockers
Allergy to soybean oil or egg lecithin
Known liver failure, cirrhosis or pancreatitis
Prior directives against advanced life support
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Intervention: Calcitriol
Trial phase: Phase 4
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
Eligibility criteria:
Inclusion Criteria:

Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
Subject will be able to complete the study, to the best of his/her knowledge
Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
Anticipated parathyroidectomy (partial or full) within 6 months after randomization
Have a scheduled date for kidney transplant surgery
Received cinacalcet since initiating hemodialysis
Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
Subject is pregnant (eg, positive HCG test) or is breast-feeding
Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
Intervention: Ciclopirox Olamine
Trial phase: Not Applicable
SMILES: Cc1cc(C2CCCCC2)n(O)c(=O)c1.NCCO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 220
Group description: Ciclopirox Olamine Topical Suspension
Eligibility criteria:
Inclusion Criteria:

Male or female at least 10 years of age, and otherwise healthy
Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
In good health with no clinically significant disease that might have interfered with study evaluations
Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

History of hypersensitivity or allergy to ciclopirox
Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
Had a history of dermatophyte infection unresponsive to antifungal treatment
Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
Was unwilling to sign the informed consent
Female who was pregnant or lactating
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.
Intervention: Troglitazone
Trial phase: Phase 2
ATC code: A10BG01
SMILES: Cc1c(C)c2c(c(C)c1O)CCC(C)(COc1ccc(CC3SC(=O)NC3=O)cc1)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
Eligibility criteria:
Inclusion Criteria:

Written informed consent prior to any study-related procedures
Ability to read and understand the English language
Bronchiectasis confirmed by CT scan of the chest
Previous treatment with antibiotics for bronchiectasis
Documented history of positive sputum culture for a gram-negative organism within 5 years
Positive sputum culture for a gram-negative organism at first visit (Day -14)

Exclusion Criteria:

Hospitalization or hemoptysis > 30 mL within 14 days of first visit (Day -14)
Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14), excluding chronic, stable azithromycin use
Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day -14)
Forced expiratory volume in 1 second (FEV1) < 25% predicted approximately 15 minutes following use of a bronchodilator at first visit (Day -14)
Cigarette smoking within 6 months of first visit (Day -14)
Intervention: Testosterone
Trial phase: Not Applicable
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Healthy, premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.
Eligibility criteria:
Inclusion Criteria:

Women aged 18-75 years and men 45-75 years
Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care