anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ergocalciferol
Trial phase: Not Applicable
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
ages 18-75 years

Exclusion Criteria:

Diagnosis of any other autoimmune disease:

such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'

Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke
Severe heart problems
Kidney failure requiring dialysis treatment
Liver failure or cirrhosis of the liver
Poorly controlled hypertension
current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
Pregnancy
Intervention: Epoprostenol
Trial phase: Phase 3
ATC code: B01AC09
SMILES: CCCCCC(O)C=CC1C(O)CC2OC(=CCCCC(=O)O)CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 years and above
Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins
Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil
Women of childbearing potential must use a reliable method of contraception
Signed informed consent prior to initiation of any study mandated procedure

Exclusion Criteria:

Patients with respiratory and/or cardiovascular distress in need of emergency care
Known or suspicion of pulmonary veno-occlusive disease (PVOD)
Current use of IV inotropic agents
Current use of any prostacyclin or prostacyclin analog other than Flolan®
Tachycardia with heart rate > 120 beats/min at rest
PAH related to any condition other than those specified in the inclusion criteria
Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
History of myocardial infarction

History of left-sided heart disease, including any of the following:

hemodynamically significant aortic or mitral valve disease
restrictive or congestive cardiomyopathy
left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
unstable angina pectoris
life-threatening cardiac arrhythmias
Chronic bleeding disorders
Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
Women who are pregnant or breast-feeding
Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months
Intervention: Misoprostol
Trial phase: Phase 3
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: 400 mcg buccally 2 hours prior to procedure

Misoprostol: 400 mcg buccally 2 hours prior to procedure
Eligibility criteria:
Inclusion Criteria:

English or Spanish speaking
Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment
Ultrasound used for dating purposes must be within the last two weeks.
Women 18-50 years of age undergoing surgical termination of pregnancy

Exclusion Criteria:

Spontaneous fetal demise
Ruptured membranes or intrauterine infection
Fibroids that significantly distort the uterine shape
Uterine abnormality such as unicornuate uterus
Prior transmural myomectomy
Severe oligohydramnios
Morbid obesity with BMI>45
Inability to place osmotic dilators
Intervention: Cycloserine
Trial phase: Not Applicable
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Eligibility criteria:
Inclusion Criteria:

Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

History of psychosis, obsessive-compulsive disorder, or mania
Recent substance abuse or suicidality
Previous receipt of study treatments
Intervention: Travoprost
Trial phase: Phase 3
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 442
Group description: Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.
Intervention: Travoprost
Trial phase: Phase 3
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 421
Group description: Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.
Intervention: Paclitaxel
Trial phase: Not Applicable
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3

Paclitaxel Dosage:

Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*

not to exceed 10mg total dose
Eligibility criteria:
Inclusion Criteria:

ability to provide informed consent
age 18-90 years old
Rutherford 1-6
occlusion or stenosis in the infrainguinal vessels

Exclusion Criteria:

inability to pass the guide wire across the lesion
pregnant or lactating women
specific limb has not been previously treated with endovascular intervention
Intervention: Diclofenac sodium
Trial phase: Phase 4
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or Poser criteria.
Age 18 or more
Ongoing treatment with glatiramer acetate (Copaxone) for three months or more.
No MS exacerbation for 60 days prior to screening.
Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction scale of last 3 days.
Written informed consent.

Exclusion Criteria:

Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (<325 mg daily), between screening and end of study.

Any contraindication to Diclofenac Sodium Topical Gel (DSTG)

allergy to DSTG or any NSAID.
history of asthma, urticaria, or other allergic reaction after taking any NSAID.
Females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures).
Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
Any other serious and/or unstable medical condition.
Intervention: Chlordiazepoxide
Trial phase: Not Applicable
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 102
Group description: The control group, which received an infusion of normal saline

remifentanil 1: The patients received an infusion of remifentanil
Eligibility criteria:
Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway
Intervention: Bupropion Hydrochloride
Trial phase: Phase 4
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2006
Group description: Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
Eligibility criteria:
Inclusion Criteria:

Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

Subjects with a past or current diagnosis of one of the following disorders:

a. Psychotic Disorders:

Schizophreniform
Delusional Disorder
Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)
Intervention: Thiamine
Trial phase: Not Applicable
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Open label - 200mg IV

Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
Eligibility criteria:
Inclusion Criteria:

Adult patients (age > 18 years) admitted to an ICU
Mechanically ventilated

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temp > 100 at time of VO2 measurement
FIO2 > 60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Thiamine supplementation within 24 hours prior to study enrollment
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 273
Group description: Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 18 to 65 years of age, inclusive.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.

History of meeting DSM-IV-TR criteria for:

Depressive episode with psychotic or catatonic features.
Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
Schizophrenia, schizoaffective, or other psychotic disorder.
Obsessive-compulsive disorder.
Bulimia or anorexia nervosa.
Dementia, amnesic, or other cognitive disorder.
Mental retardation.
Participants considered a suicide risk.
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 273
Group description: Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 18 to 65 years of age, inclusive.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.

History of meeting DSM-IV-TR criteria for:

Depressive episode with psychotic or catatonic features.
Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
Schizophrenia, schizoaffective, or other psychotic disorder.
Obsessive-compulsive disorder.
Bulimia or anorexia nervosa.
Dementia, amnesic, or other cognitive disorder.
Mental retardation.
Participants considered a suicide risk.
Intervention: Bendamustine
Trial phase: Phase 1 | Phase 2
ATC code: L01AA09
SMILES: Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Bendamustine is combined with standard chemotherapy
Eligibility criteria:
Inclusion Criteria:

Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy
Must have adequate liver and renal function
Zubrod Performance Status (ZPS) of 2 or better
Must have measurable disease

Exclusion Criteria:

Peripheral neuropathy of grade II or higher
Thrombocytopenia (platelets less than 50,000/uL)
Neutropenia (ANC<1000/uL)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.4 X ULN
Total bilirubin >1.5 X upper limit of normal (ULN)
Creatinine clearance of less than 45 milliliters per minute (mL/min)
Patients with HIV
Patients with active hepatitis
Pregnant or lactating women
Individuals of child-bearing potential not using adequate contraception
Individuals unable to provide informed consent
Intervention: Azarga
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
Pregnant or lactating.
Participation in any other investigational study within 30 days of screening visit.
Other protocol-defined exclusion criteria may apply.
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.

dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I
18 to 35 years of age

Exclusion Criteria:

MRI and/or PET screening criteria not met
Abnormal sleep habits/known or suspected sleep disorder(s)
Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age
Intervention: Lurasidone
Trial phase: Phase 3
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Lurasidone flexibly dosed

Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Eligibility criteria:
Inclusion Criteria:

The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion Criteria:

The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
The subject resides in a country where lurasidone has been approved for any indication.
The subject is currently enrolled in any other investigational study.
The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).