anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Eligibility criteria:
Inclusion Criteria:

Male or female subjects, 18 years of age or older.
Written informed consent and written authorization for use or release of health and research study information have been obtained.
Subject has chronic Prosthetic knee joint pain for more than 3 months.
Subject has pain 6 or greater on a 10 point Numerical Pain Rating scale
Ability to follow study instructions and likely to complete all required visits.
Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (if applicable)
Negative infectious etiology workup (joint aspiration, serological parameters such as Erythrocyte Sedimentation Rate (ESR) or C-reactive protein (CRP) and clinical examination).
Patients who were considered not to be candidates for Prosthetic knee joint revision surgery and have failed traditional treatments including oral pain medications, as determined by referring orthopedic surgeon

Exclusion Criteria:

Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
Any medical condition that may put the subject at increased risk with exposure to BOTOX ®including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or known disorders of neuromuscular function
Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Know allergy or sensitivity to any of the components in the study medication.
History of recent or ongoing alcohol or drug abuse.
Known, uncontrolled systemic disease.
Concurrent participation in another research study
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Patients whose pain is rated as less than 6 on a 10 point Numerical Pain Rating scale at the screening visit
Intervention: Paroxetine
Trial phase: Phase 3
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
Eligibility criteria:
Inclusion Criteria:

Male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S;
A minimum 6-month duration of PTSD illness; 3)CGI-S score of 4 or higher and a total CAPS-2 severity score of 50 or higher at the baseline visit;
Homozygous for either the S/S or L/L 5-HTT;
Females must not be pregnant or lactating and must agree to an acceptable form of contraception while receiving study medication and for 1 month after.

Exclusion Criteria:

Presence of any other primary axis I disorder (concurrent depression will be permitted if it is judged to be secondary to development for PTSD);
Suicide ideation or attempts within the past 3 months;
Alcohol or substance abuse or dependence in the past six months;
Evidence of clinically significant hepatic or renal disease;
Previous seizure disorder or condition predisposing to seizures, or on medications that might lower the seizure threshold
Any acute or unstable medical condition that might interfere with the safe conduct of the study;
Intolerance or hypersensitivity to citalopram or any other SSRI;
Treatment with a monoamine oxidase inhibitor within 14 days of initiating the study;
Concomitant treatment with serotonin agonists, other SSRIs, meperidine, tramadol or other medication as determined by the study clinician.
PTSD symptoms in need of immediate treatment as determined by clinical assessment from a psychiatrist not affiliated with the study.
Intervention: Glucosamine Sulfate
Trial phase: Phase 4
SMILES: NC(C=O)C(O)C(O)C(O)CO.NC(C=O)C(O)C(O)C(O)CO.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 250
Group description: The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
Eligibility criteria:
Inclusion Criteria:

Low back pain for more than 6 months
Patient older than 25 years old
MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Exclusion Criteria:

Spinal stenosis with neurological deficits
Spinal prolapse with neurological deficits
Rheumatoid arthritis, psoriatic arthritis,
Old lumbar fractures
Chronic pain syndromes (e.g. fibromyalgia)
Psychosocial status not suitable for participation
Pregnancy
Breastfeeding
Allergic to shellfish
Intervention: Ciclesonide
Trial phase: Phase 4
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 741
Group description: 320 mcg/day or 640 mcg/day
Eligibility criteria:
Main inclusion criteria:

Written informed consent
18 years or older with diagnosis of asthma for at least 6 months
Clinically stable asthma at the time of study enrollment
Clinical requirements for treatment with ICS as outlined in the Canadian Asthma Consensus Guidelines
If patients are currently on ICS, the dose must be stable for 3 months and they must be willing to switch

Main exclusion criteria:

On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy
Severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids
Mild asthma requiring short acting beta-2-agonists only
Patients with a contraindication to ICS therapy
Any other disease or medical condition requiring further clinical evaluation, which in the opinion of the Primary Care Practitioner may interfere with the clinical study or interfere with the diagnosis of asthma.
Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Intervention: Nesiritide
Trial phase: Phase 1 | Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography
No signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure

Exclusion criteria:

Myocardial Infarction (MI) within 3 months of screening
Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion
Total bilirubin of > 1.5 mg/dL or other liver enzymes > 1.5 times the upper limit of normal (mg/dL = milligrams per deciliter)
Serum creatinine of > 3.0 mg/dL
Serum sodium of < 125 mEq/dL or > 160 mEq/dL (milliequivalents per deciliter)
Serum potassium of < 3.5 mEq/dL or > 5.0/dL
Serum digoxin level of > 2.0 ng/ml (nanograms per milliliter)
Systolic pressure of < 85 mm Hg (millimeters of mercury)
Hemoglobin < 10 gm/dl (grams per deciliter)
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 241
Group description: For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Eligibility criteria:
Inclusion Criteria:

Males or females, between 18 and 55 years of age, at the time of consent.
Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

Exclusion Criteria:

Subjects who are unable to provide informed consent
Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
Females who are pregnant, breast feeding, or lactating at screening.
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 60
Group description: 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
Normal intelligence
Able to swallow capsules

Exclusion Criteria:

Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
Prior treatment with atomoxetine
History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
History of severe allergies or multiple adverse drug reactions
Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 61
Group description: 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
Normal intelligence
Able to swallow capsules

Exclusion Criteria:

Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
Prior treatment with atomoxetine
History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
History of severe allergies or multiple adverse drug reactions
Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: 75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
Eligibility criteria:
Inclusion Criteria:

Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

Exclusion Criteria:

Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
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: 111
Group description: Duloxetine 60/120 mg QD
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Acute liver injury (such as hepatitis) or severe cirrhosis.
Previous exposure to duloxetine.
Body Mass Index (BMI) over 40.
Major depressive disorder.
Daily use of narcotics.
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: 116
Group description: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
Eligibility criteria:
Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain. Exclusion Criteria: - You have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study. - Have acute liver injury (such as hepatitis) or severe cirrhosis. - Have had previous exposure to duloxetine. - Have a body mass index (BMI) over 40. - Have major depressive disorder. - Require daily narcotics.
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: 112
Group description: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
Eligibility criteria:
Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain. Exclusion Criteria: - You have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study. - Have acute liver injury (such as hepatitis) or severe cirrhosis. - Have had previous exposure to duloxetine. - Have a body mass index (BMI) over 40. - Have major depressive disorder. - Require daily narcotics.
Intervention: Valsartan
Trial phase: Phase 2
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 268
Group description: Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 18 years old or older
Subjects who are hospitalized for ischemic chest discomfort at rest lasting at least 10 minutes and consistent with cardiac ischemia
Final diagnosis of acute coronary syndrome
Elevated concentrations of natriuretic peptide 3-10 days after admission for their qualifying acute coronary syndrome event

Exclusion Criteria:

Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARBs), renin antagonists, or to drugs with similar chemical structures.
Presence of clinically overt heart failure
Known evidence of left ventricular systolic dysfunction
Percutaneous coronary intervention (PCI) less than 24 hours before randomization.
Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is clinically required with no reasonable alternative therapy available.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: HYDROXYPROGESTERONE CAPROATE
Trial phase: Phase 2
ATC code: G03DA03
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CCCCC)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
Eligibility criteria:
Inclusion Criteria:

Singleton gestation prior to 20 0/7 weeks gestation
Planning to receive or receiving 17-OHPC (250 mg IM weekly)
Previous history of preterm birth
Able to give consent

Exclusion Criteria:

Fetal demise, anomaly, or growth restriction
Hepatic or renal dysfunction
Placental previa or abruptio placenta
Polyhydramnios/oligohydramnios
Short cervix or planned cerclage
Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs
Participation in another interventional study that influences gestational age at delivery
Heparin treatment of known platelet count <100,000/mm3 (because of contraindication to intra-muscular injections)
Intervention: Mirabegron
Trial phase: Phase 2
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Men 45 years of age or older
Documented bladder outlet obstruction

Exclusion Criteria:

History of urinary retention
Symptomatic and recurrent urinary tract infection (UTI)
Intervention: Mirabegron
Trial phase: Phase 2
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Men 45 years of age or older
Documented bladder outlet obstruction

Exclusion Criteria:

History of urinary retention
Symptomatic and recurrent urinary tract infection (UTI)
Intervention: Gatifloxacin
Trial phase: Phase 4
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: topical gatifloxacin 4 times per day

gatifloxacin
Eligibility criteria:
Inclusion Criteria:

intravitreous injection

Exclusion Criteria:

antibiotic use
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Active treatment. No adverse events recorded
Eligibility criteria:
Inclusion criteria

Type 2 diabetes diagnosed according to and in accordance with the WHO criteria
Metformin treatment of ≥ 1 gram
7,5 % ≤ HbA1c ≤ 10%
Age > 18
BMI ≥ 25 kg/m2
Informed consent
Contraception, if appropriate

Exclusion criteria

Proliferating retinopathy
Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria (>300 mg/day)
Liver disease with ALAT and/or ASAT > 2 x normal value
Complicated coronary artery disease, NYHA group III and IV
Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies
Occurrence of type 1 diabetes in first degree relatives
Anaemia
Pregnancy and/or breast feeding
Treatment with medication affecting insulin secretion
non-compliance

Withdrawal criteria

The subject may withdraw at will at any time
Pregnancy discovered during the trial
Severe illness
Unacceptable side effects
If self-measured fasting plasma glucose on three consecutive days exceeds 15 mM, the result is repeated in an immediately scheduled visit, and no treatable intercurrent cause for the hyperglycaemia can be found.