anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Milnacipran
Trial phase: Phase 3
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 134
Group description: Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Eligibility criteria:
Key Inclusion Criteria:

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Key Psychiatric Exclusion Criteria:

DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol
Intervention: Milnacipran
Trial phase: Phase 3
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 138
Group description: Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Eligibility criteria:
Key Inclusion Criteria:

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Key Psychiatric Exclusion Criteria:

DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol
Intervention: Premarin
Trial phase: Phase 4
ATC code: G03CA57
SMILES: CC12CCC3c4ccc(OS(=O)(=O)[O-])cc4CCC3C1CCC2=O.[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal: no menses for >1 year
Minimum age: 48 years
Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
Medically fit for elective surgery
Physically able to apply/insert the study drug
Available for clinic follow-up for minimum 1yr

Exclusion Criteria:

Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
BMI >35 kg/m2
Recent history (within last month) of vaginal infection or vaginitis
Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
History of connective tissue disease
Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
History of vaginal irradiation
Allergy to Premarin or its constituents
Prior apical repair or use of mesh for prolapse repair
Current tobacco use
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most

Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with mild to moderate psoriasis vulgaris, chronic plaque type, with PASI score not more than 10
Adult patients ≥ 19 years old and ≤ 65 years old
Male or female
Able to give consent
Able to follow-up monthly for 6 months

Exclusion Criteria:

Patients with PASI score ≥ 10
Systemic therapy for psoriasis within the last two months
Phototherapy within the last four weeks
Known allergy to any of the treatments
Active liver disease or liver enzymes (AST and ALT) more than 3 times the upper limit of normal
Any myopathy or presence of elevated creatine kinase (CK-MM) levels
Intake of any drug that might affect or interact with the study drug (e.g. fibrates, niacin, macrolide antibiotics)
Patients already taking statins or patients with clear indications for statin treatment (i.e. coronary heart disease or disease equivalents according to the Adult Treatment Panel III Guidelines)
Impaired renal function or creatinine > 2.0 mg/dL
Active infection or WBC > 10
Pregnant or lactating
Uncontrolled hypertension, endocrine or other metabolic diseases
Intervention: Amcasertib
Trial phase: Phase 2
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(-c4csc(-c5ccccc5)n4)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants who were enrolled into the study received amcasertib (BBI503), administered orally, once daily. Dosing began at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events was allowed according to following schedule: Full dose: 200 mg daily; Modification Level-1: 100 mg daily; Modification Level-2: 50 mg daily.
Eligibility criteria:
Key inclusion criteria:

Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point.
Recurrent or relapsed after completion of initial therapy of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point (includes completion of surgery with or without postoperative chemotherapy, including maintenance chemotherapy)

Elevation of CA-125 according to the following definitions:

Patients with an elevated CA-125 before chemotherapy and normalization of CA-125 with/after chemotherapy must show evidence of CA-125 greater than or equal to 2 times the upper limit of normal (ULN) on 2 occasions at least 1 week apart
Patients with an elevated CA-125 before cancer chemotherapy, which never normalizes, must show evidence of CA-125 greater than or equal to 2 times the nadir value on 2 occasions at least 1 week apart

Patients with CA-125 in the normal range before cancer chemotherapy must show evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart

For patients who have received subsequent treatment for recurrent cancer, "chemotherapy" in the above criteria refers to the most recent round of chemotherapy.
Patients with a history of ovarian cancer who are asymptomatic and who do not have documented previous CA-125 levels may enroll if the CA-125 is greater than three times the ULN on two occasions, at least one week apart
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0

Key exclusion criteria:

Symptoms (other than ≤ grade 1 fatigue, anxiety, depression, or other psychological symptoms) that, in the opinion of the treating oncologist, are a direct result of cancer recurrence. (Examples of symptoms that would preclude enrollment include unintentional weight loss, ≥ grade 2 fatigue, and new abdominal pain unrelated to operative procedures for the ovarian malignancy.)
Receiving any other investigational agent that would be considered a treatment for the primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents ≤14 days of first dose of study drug
Major surgery ≤28 days before start of treatment
History of another primary malignancy with an associated disease-free interval of less than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix.
Intervention: JNJ-42165279
Trial phase: Phase 2
SMILES: O=C(Nc1cnccc1Cl)N1CCN(Cc2ccc3c(c2)OC(F)(F)O3)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well
Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at Screening and Baseline
Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (<=) 18
Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, at screening
Female participants must be either postmenopausal or surgically sterile

Exclusion Criteria:

Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included
Participants is currently receiving specific psychotherapy for SAD
Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or clonazepam >= 2.5 mg/day or its equivalent)
Concurrent use of psychotropic medications
has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it
Intervention: Iopamidol
Trial phase: Not Applicable
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: 100 of the first 200 subjects will be randomized to a fixed dose of contrast material.

Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
Eligibility criteria:
Inclusion Criteria:

Patients referred for a CT of the Abdomen & Pelvis with Contrast Material

Exclusion Criteria:

Younger than 18
Pregnant
Contraindication of iodinated contrast material
Contraindication to a bolus injection
Indication for biphasic exam (arterial + venous phases)
Diffuse hepatic disease
Subjects weighing more than 300 pounds
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: 10 mg daily for the 12 weeks

dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes
Eligibility criteria:
Inclusion Criteria:

Age 20-80 years inclusive.
Type 2 diabetes
BMI ≥30 kg/m2
Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will be allowed as long as they are on stable doses of these -compounds and the dosage in not changed during the course of study. -Patients will be evenly distributed between the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.
HbA1c ≤ 8.0%

Exclusion Criteria:

Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.
Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and -hypertriglyceridemia.
Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery bypass, surgery or coronary angioplasty) in the previous 3 months.
Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver -function defined as:
aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine aminotransferase (ALT) >3x ULN
Total bilirubin >2.0 mg/dL (34.2 µmol/L)
Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
(liver function tests more than 3 times the upper limit of normal)
Renal impairment (serum eGFR <60 ml/min)
Any other life-threatening, non-cardiac disease
Uncontrolled hypertension (BP > 160/100 mm of Hg)
Congestive Heart Failure class III or IV.
Use of an investigational agent or therapeutic regimen within 30 days of study
Participation in any other concurrent clinical trial
pregnant or breastfeeding patients
Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics
Intervention: Amitriptyline
Trial phase: Phase 2 | Phase 3
ATC code: N06AA09 | N06CA01
SMILES: CN(C)CCC=C1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Eligibility criteria:
Inclusion Criteria:

Age 18 or older and able to consent for themselves.
Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
Able to speak and read the English language.
Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux.
Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study.

Exclusion Criteria:

Environmental allergies.
Smoking within past 5 years.
Using ginko bilboa (or unwilling to cease using it).
Current upper respiratory infections.
Use of narcotics (e.g. oxycodone, methadone).
Any prior history of amitryptiline use.
Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
History of urinary retention.
Any history of major depressive disorder.
Any prior history of allergy to a tricyclic antidepressant.
Current diagnosis of gastroesophageal reflux (GERD).
For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods).
Intervention: Morphine
Trial phase: Phase 4
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: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.

Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.
Eligibility criteria:
Inclusion Criteria:

Children aged 7-18 years
sickle cell anemia patient with severe acute painful crisis
Parental consent and child assent where applicable

Exclusion Criteria:

Oxygen saturations below 90% on initial assessment
Altered conscious and mental state that hinders communication
Current enrollment in another clinical trial involving an investigational drug.
History of a stroke
Hypertension,
Increased intracranial pressure.
Glaucoma,
Failed/ Difficult IV access
Intervention: Desipramine
Trial phase: Phase 2
ATC code: N06AA01
SMILES: CNCCCN1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
Eligibility criteria:
Inclusion Criteria:

Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

Exclusion Criteria:

Cardiovascular disease other than well controlled hypertension
Depression
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 115
Group description: Eligible participants will receive 40 mg of atorvastatin

Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 30 - 70 years old
BMI: 20 - 37 kg/m2
Without diabetes as defined by fasting plasma glucose <126 mg/dL and not taking glucose lowering medications
Eligible for statin therapy for primary prevention of ASCVD based on LDL-C ≥ 130 mg/dL, > 5% ASCVD risk over 10 years, or hs-CRP ≥ 2.0 mg/L

Exclusion Criteria:

Younger than 30 or older than 70 years
Persons with any significant co-morbidities, such as diabetes (fasting glucose ≥ 126 mg/dL or use of glucose lowering medications), active coronary artery disease, heart failure, accelerated or malignant hypertension, kidney disease (creatinine ≥ 1.5 mg/dL), liver disease (alanine aminotransferase > 2 times upper limit of normal), or severe anemia (hematocrit < 30%).
Individuals taking any medications for weight loss or known to influence insulin sensitivity.
Pregnant or lactating
Women unwilling to use an effective birth control method
History of statin intolerance