anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients are given the drug Atomoxetine and Remediation Control training.

Atomoxetine: 40mg 2po qam
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
Males and females.
Ages 18-60 years old.
All races and ethnicities.

Exclusion Criteria:

Diagnosis of an organic brain disease.
Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol or substance dependence within the last 3 months.
Meet criteria for primary negative symptoms, established by clinical judgment.
Current or past history of clozapine treatment for antipsychotic non-response.
Patients hospitalized in a psychiatric hospital within the previous 30 days.
Patients with an unstable medical condition, as determined by the Investigator
Colorblindness
Concurrent treatment with electroconvulsive therapy or psychotherapy.
Pregnant women.

Must be able to read, speak, and understand English.

We do not have the resources necessary to properly study non-English speaking patients in this study. The computer software used for cognitive remediation and some clinical assessments are only available in English. The need to provide such resources in foreign languages would be prohibitive to the successful completion of the study.
Intervention: Defibrotide
Trial phase: Phase 3
ATC code: B01AX01
SMILES: CC(C)c1cc(-c2n[nH]c(=O)n2-c2ccc3c(ccn3C)c2)c(O)cc1OP(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1154
Group description: Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
Eligibility criteria:
Inclusion Criteria:

Entry criteria include the following:

Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven:

1.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical findings:

Ascites (radiographic or physical exam)
Weight gain of ≥5% compared to the day of conditioning-- if this value is not available, the weight on the date of admission to the SCT unit may be used)
Hepatomegaly; increased over baseline.

1.2 Modified Seattle Criteria: At least two of the following

Bilirubin ≥2 mg/dL
Ascites (radiographic or physical exam) and/or weight gain ≥5% above baseline weight (defined as weight on the first day of conditioning- if this value is not available, the weight on the date of admission to the SCT unit may be used)
hepatomegaly increased over baseline

1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible.

Patient must also provide written informed consent.

Exclusion Criteria:

Use of any medication which increases the risk of hemorrhage is disallowed. Use of heparin or other anticoagulants is disallowed within 12 hours unless being used for routine central venous line management, fibrinolytic instillation for central venous line occlusion, intermittent dialysis or ultrafiltration of CVVH.
Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring > 15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and requiring > 300cc of packed red blood cells/24 hours, or an adult patient weighing 70 kg and requiring >3 units of packed red blood cells/24 hours) to replace blood loss, OR bleeding from a site which in the Investigator's opinion constitutes a potential life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of amount of blood loss, at any point from the date of SCT through the date of severe VOD diagnosis.
Hemodynamic instability as defined by a requirement for multiple pressors, or inability to maintain mean arterial pressure (for children: to maintain mean arterial pressure within 1 standard deviation of age-adjusted levels) with single pressor support.
Woman who are pregnant.
Intervention: 2-(2-Chloro-5-(((2S)-3-(5-chloro-2,3-dihydrospiro(benzofuran-2,4'-piperidin)-1'-yl)-2-hydroxypropyl)oxy)-4-((methylamino)carbonyl)phenoxy)-2-methylpropanoic acid
Trial phase: Phase 2
SMILES: CNC(=O)c1cc(Cl)c(OC(C)(C)C(=O)O)cc1OCC(O)CN1CCC2(CC1)Cc1cc(Cl)ccc1O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: AZD4818 Turbuhaler
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of COPD, with symptoms for more than 1 year
Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion Criteria:

Clinical suspicion of active tuberculosis
Any current clinically significant respiratory tract disorder other than COPD
History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Intervention: Ospemifene
Trial phase: Phase 2
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Naturally or surgically menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Intervention: Ospemifene
Trial phase: Phase 2
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Naturally or surgically menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Intervention: Ospemifene
Trial phase: Phase 2
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Naturally or surgically menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Intervention: Betamethasone
Trial phase: Phase 4
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: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 97
Group description: Maxidex 1 drop in each eye 2 times daily
Eligibility criteria:
Inclusion Criteria of Sjorgren's Population:

Inclusion Criteria:

17 years or older
LogMar visual acuity of 0.6 or better
Ocular inflammation associated with Sjogren's Syndrome

Exclusion Criteria:

Has had an adverse reaction to either topical of systemic steroids in the past
Has diabetes (type 1 or 2)
Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1
Has worn contact lenses within one week prior to Visit 1
Has received ocular prescription therapy in the last 30 days
Has active ocular infections or inflammation not associated with Sjogren's Syndrome.
Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
Eligibility criteria:
Inclusion Criteria:

Stable antiretroviral therapy for at least 12 months
Screening CD4+ T cell count < 350 cells/mm3
All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).
>90% adherence to therapy within the preceding 30 days, as determined by self-report
Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
**Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period
Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
Concurrent treatment with phenobarbital, phenytoin, or rifampin.
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute
Pregnant or breastfeeding women
Intervention: Bosentan
Trial phase: Phase 3
ATC code: C02KX01 | G01AE10
SMILES: COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
Eligibility criteria:
Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.

Signed informed consent prior to initiation of any study-related procedures.
Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.

Exclusion Criteria:

Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
Pregnancy or breast-feeding.
AST and/or ALT > 3 times the upper limit of the normal range.
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 hypersensitivity to bosentan or any of the excipients.
Intervention: Mirtazapine
Trial phase: Phase 3
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 342
Group description: Participants receive esmirtazapine 4.5 mg tablets, administered QD
Eligibility criteria:
Inclusion Criteria:

are at least 18 and less than 65 years;
sign written informed consent after the scope and nature of the investigation have been explained;
have shown capability to complete the LogPad questionnaires;
have difficulty falling asleep, maintaining sleep or have early morning awakening;

Exclusion Criteria:

Significant medical or psychiatric illness causing sleep disturbances.
Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
Routinely nap during the day.
Have a Body Mass Index (BMI) of 36 or more.
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 111
Group description: Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
Eligibility criteria:
Inclusion Criteria:

Healthy 18 to 55 years old males

Exclusion Criteria:

Screening sperm count <20 x 106/mL; screening sperm motility <50% motile (a+b) or <25% Class "a" motile or screening sperm morphology <30% normal or semen volume <1.5 mL or white blood cell count >1 x 106 /mL on any screening visit sample
Intervention: Vardenafil
Trial phase: Phase 3
ATC code: G04BE09
SMILES: CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 184
Group description: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Eligibility criteria:
Inclusion Criteria:

Males 18 years-of-age or older
Stable, heterosexual relationship for at least 6 months
A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

Any underlying cardiovascular condition, including unstable angina pectoris
History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
Uncontrolled atrial fibrillation / flutter at screening
History of surgical prostatectomy for prostate cancer
Hereditary degenerative retinal disorders
History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
Presence of penile anatomical abnormalities
Subjects who have been confirmed with phenylketonuria (PKU)
Spinal cord injury
Resting or postural hypotension or hypertension
Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
Use of any treatment for ED within 7 days of Visit 1
History of congenital QT prolongation
History of syncope within the last 6 months prior to entry into the study
Intervention: Ziprasidone
Trial phase: Phase 2
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.

Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
Eligibility criteria:
Inclusion Criteria:

Written informed consent.
Men or women, 18-65 years of age.
MDD, current, according to DSM-IV criteria and as diagnosed by the SCID- I/P during the screen and baseline visit of phase 1.
A HAM-D-17 score > 14 during the screen and baseline visit of phase 1.

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
Device, tubal ligation, or partner with vasectomy).
Serious suicide or homicide risk, as assessed by evaluating clinician.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
History of multiple adverse drug reactions or allergy to the study drug.
The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
Patients requiring excluded medications (see appendix 1 for details).
Psychotic features in the current episode or a history of psychotic features.
Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
Any investigational psychotropic drug within the last 3 months.
Have failed more than 3 adequate antidepressant trials during the current MDE. Some examples of adequate dosage of an antidepressant trial include either > 150 mg of imipramine (or its tricyclic equivalent), > 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), > 20 mg of fluoxetine (or its SSRI-equivalent), > 150mg of bupropion, > 300mg of trazodone (or nefazodone), >75 mg of venlafaxine, >60mg of duloxetine, or > 15mg of mirtazapine. A trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.
Intervention: Droxidopa
Trial phase: Phase 3
ATC code: C01CA27
SMILES: N[C@H](C(=O)O)[C@H](O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Double-blind

Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Eligibility criteria:
PATIENT INCLUSION CRITERIA:

Male or female and aged 18 years or over;
Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathies;
A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing;
Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

MAIN PATIENT EXCLUSION CRITERIA:

Taking ephedrine or midodrine; Patients taking ephedrine or midodrine may enroll after a minimum 7 day washout period;
Taking anti-hypertensive medication;
Have a history of more than moderate alcohol consumption;
Women who are pregnant or lactating;
Have a history of closed angle glaucoma;
Have pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting position);
Have atrial fibrillation or, in the investigator's opinion, have any other significant cardiac arrhythmia;
In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness;
Have diabetes mellitus or insipidus;
Have a known or suspected malignancy;
Have known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug;
In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing;
Have a serum creatinine level > 130 µmol/L;
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: No
Participants at risk: 80
Group description: Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
Eligibility criteria:
Inclusion Criteria:

Participants having painful symmetric neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) in the lower limbs applicable to both of the following conditions: decreased sensation of leg to monofilament, none or decreased ankle reflexes or decreased vibratory sensation and pain symptoms such as numbness (loss of sensation), tingling, paresthesia (a skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause), burning, shooting pain, stabbing or lancinating (characterized by a sensation of cutting, piercing, or stabbing) pain
Participants having painful diabetic neuropathy in the lower limbs for 3 months before randomization
Participants diagnosed with Type ll diabetes and stable blood sugar level controlled with an oral medication, insulin or diet therapy for 3 months before randomization
Participants with glycated hemoglobin (HbA1c) less than or equal to 10 percent
Participants with pain intensity score of greater than or equal to 4 on numeric rating scale (NRS) for the last 48 hours

Exclusion Criteria:

Participants who have previously experienced failure of tramadol treatment or have discontinued tramadol administration due to adverse event
Participants who have received the prohibited medication before randomization (e.g., capsaicin, use of systemic steroids, steroid or local anesthetic injections, tramadol HCl or tramadol combination, gabapentin, opioid analgesics, antidepressants, anticonvulsants, alpha-lipoic acid, acupuncture, COX-2 selective inhibitors, long-acting NSAIDs, opioid analgesics, sedative-hypnotics, muscle relaxants, anxiolytics, antipsychotics, TENS, short-acting non-opioid analgesics)
Participants with neuropathic pain caused by other reasons (e.g., alcohol abuse, connective tissue disease, toxic exposure, infection, neoplasm, ischemia)
Participants suffering from painful diabetic neuropathy over 10 years
Participants with physical damage or disease which may cause abnormal absorption, excessive accumulation, metabolism or excretion disorder of the study medication