anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Donepezil
Trial phase: Phase 2
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 45
Group description: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)

donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
Eligibility criteria:
Inclusion Criteria:

confirmed genetic diagnosis of fragile X syndrome
age >=12, <=29
Verbal IQ >= 50, <=75
Tanner pubertal stage >= 3

Exclusion Criteria:

Current or lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder, NOS based upon reported history
Poorly controlled seizure disorder or taking more than one anticonvulsant (subjects cannot be prescribed carbamazepine, phenytoin, or phenobarbital due to potential interaction effects with donepezil). The investigators will permit one anticonvulsant as monotherapy for seizures if the seizure disorder is well controlled with no evidence of break through seizures within the past year
Concomitant or anticipated use of other medications having prominent effects on the cholinergic system (e.g., bethanechol, benztropine, atropine, succinylcholine)
Medications or nutritional supplements that have the potential to significantly alter donepezil levels, clinical effects or adverse reactions (antifungal agents, corticosteroids, erythromycin, beta-blockers, calcium channel blockers, NSAIDs, gingko biloba, St. John's wort)
Medical illnesses where donepezil could worsen the condition such as asthma, cardiac conduction abnormalities, urinary obstruction or gastrointestinal disease with gastric bleeding
Pregnancy or sexually active females not using a reliable method of contraception
If considering participation in brain MRI part of the study, then any contraindications for MRI (e.g., orthodontia, metal in or on the body, etc.)
Intervention: Lactose
Trial phase: Phase 2
SMILES: OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 45
Group description: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)

sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
Eligibility criteria:
Inclusion Criteria:

confirmed genetic diagnosis of fragile X syndrome
age >=12, <=29
Verbal IQ >= 50, <=75
Tanner pubertal stage >= 3

Exclusion Criteria:

Current or lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder, NOS based upon reported history
Poorly controlled seizure disorder or taking more than one anticonvulsant (subjects cannot be prescribed carbamazepine, phenytoin, or phenobarbital due to potential interaction effects with donepezil). The investigators will permit one anticonvulsant as monotherapy for seizures if the seizure disorder is well controlled with no evidence of break through seizures within the past year
Concomitant or anticipated use of other medications having prominent effects on the cholinergic system (e.g., bethanechol, benztropine, atropine, succinylcholine)
Medications or nutritional supplements that have the potential to significantly alter donepezil levels, clinical effects or adverse reactions (antifungal agents, corticosteroids, erythromycin, beta-blockers, calcium channel blockers, NSAIDs, gingko biloba, St. John's wort)
Medical illnesses where donepezil could worsen the condition such as asthma, cardiac conduction abnormalities, urinary obstruction or gastrointestinal disease with gastric bleeding
Pregnancy or sexually active females not using a reliable method of contraception
If considering participation in brain MRI part of the study, then any contraindications for MRI (e.g., orthodontia, metal in or on the body, etc.)
Intervention: Utibron Neohaler
Trial phase: Phase 3
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Eligibility criteria:
Inclusion Criteria:

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Citrulline
Trial phase: Phase 1 | Phase 2
SMILES: NC(=O)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: IV bolus of 150 mg/kg L-citrulline at the initiation of bypass, followed by L-citrulline (200 μmol/L) addition to the filtration or hemoconcentration replacement fluid used during bypass. Plus L-citrulline (20 mg/kg) bolus 30 minutes after decannulation from bypass, immediately followed by 9 mg/kg/h continuous L-citrulline infusion for 48 hours.

Intravenous L-Citrulline
Eligibility criteria:
Inclusion Criteria:

Informed Consent signed by the subject's legal representative
Subjects < 6 years old
Subjects undergoing cardiopulmonary bypass for repair of an atrial septal defect, a ventricular septal defect or an atrioventricular septal defect

Exclusion Criteria:

Pulmonary artery or vein abnormalities being addressed surgically
Preoperative requirement for invasive mechanical ventilation or intravenous inotrope support
Any condition which, in the opinion of the investigator, might interfere with study objectives
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Testosterone x 24 weeks

Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18- 45 years; if participating in the neuroimaging sub study, age 18-40
Meet DSM-IV criteria for AN (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of <18.5 kg/m2 with or without amenorrhea.
Free T below the median for healthy women of reproductive age
All participants will be required to have a treatment team in place that consists of (at least) a primary care physician and a psychotherapist. Participants will need to have had regular contact with a primary care physician and be in an individual psychotherapy program. Participants will agree to continue with this treatment team and therapy throughout the active course of the study. If participants are taking psychotropic medications, the dose must be stable for 3 months before study entry

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using medically accepted means of contraception (to include oral contraceptive, patch or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Serious suicide risk, substance use disorder active within last 6 months, bipolar I disorder, severe current depressive symptoms (indexed by HAM-D score >20 [excluding 2 eating/weight loss items related to the symptoms of AN]), or psychotic disorder
New psychotropic drug regimen, specifically a significant dose change or change in drug class, within the last 6 weeks. A study psychiatrist will assess whether PRN medications and dose changes are clinically significant enough to defer enrollment of specific potential study subjects.
Untreated hypothyroidism
If receiving estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior 3 months
Use of androgens or androgen precursors, including T, DHEA and methyl T, within 3 months
Any investigational psychotropic drug within the last 3 months
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period
Alanine aminotransferase (ALT) > 2x upper limit of normal
Creatinine >1.5x upper limit
Serum potassium < lower limit of normal
If participating in the sub study, unable to tolerate 1 hour in MRI; contraindication to MRI (such as implanted pacemaker, cerebral aneurysm clips, extensive orthopedic hardware instrumentation); gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection); history of psychosis by SCID
Intervention: Desvenlafaxine
Trial phase: Phase 4
ATC code: N06AX23
SMILES: CN(C)CC(c1ccc(O)cc1)C1(O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 217
Group description: Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
Eligibility criteria:
Inclusion Criteria:

Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.

Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:

an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
a change in duration (absolute change of 2 or more days); or
periods of amenorrhea lasting at least 3 months.
A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.

Exclusion Criteria:

Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 863
Group description: Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
Eligibility criteria:
Key Inclusion Criteria:

The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.

During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Key Exclusion Criteria:

The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
The patient has psychotic symptoms or had psychosis during the double-blind study.
The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.
Intervention: Triamcinolone
Trial phase: Not Applicable
ATC code: A01AC01 | C05AA12 | D07AB09 | D07BB03 | D07CB01 | D07XB02 | H02AB08 | R01AD11 | R03BA06 | S01BA05 | S02CA04
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: corticosteroid injection into subacromial space

corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
Eligibility criteria:
Inclusion Criteria:

Patients presenting with rotator cuff symptoms for at least 4 weeks
Examination reveals diffuse pain with provocative maneuvers
Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
Willingness to participate in an investigational technique
Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)

Exclusion Criteria:

Previous rotator cuff repair
Complete rotator cuff tear or two tendon tears
Pt w/ complex regional pain syndrome
Cervical neuropathy or other nerve pathology
RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
Evidence of intraarticular arthritis
Work related or compensable injury
Previous treatment: corticosteroid injection in the last 6 months
Patients who are currently pregnant
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 3
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Eligibility criteria:
Inclusion Criteria:

0 to 3 years of age.
Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
Informed consent signed by a parent or legal guardian.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
Patients with posttraumatic cataract.
Active uveitis in the study eye.
Ocular neoplasm in the study eye.
Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
History of steroid-induced intraocular pressure (IOP) rise.
Currently on medication for ocular hypertension or glaucoma in the study eye.
Diabetes.
Other protocol-defined exclusion criteria may apply.
Intervention: Telcagepant
Trial phase: Phase 2 | Phase 3
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2660
Group description: Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Eligibility criteria:
Inclusion Criteria:

Participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles
Participant experiences headache during menstrual period in at least 2 out of last 3 cycles
Participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening
Participant agrees to use an effective method of birth control through the duration of the study

Exclusion Criteria:

Participant has basilar or hemiplegic migraine headache
Participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening
Participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening
Participant has history of significant liver disease
Participant has had cardiac surgery or symptoms within 3 months of screening
Participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine
Participant has history of neoplastic disease ≤ 5 years prior to signing informed consent
Participant has history of gastric or small intestinal surgery
Participant consumes 3 or more alcoholic drinks per day
Intervention: Retapamulin
Trial phase: Phase 4
ATC code: D06AX13
SMILES: [H][C@@]12C(=O)CC[C@]13CC[C@@H](C)[C@@]2(C)[C@H](OC(=O)CS[C@@H]1C[C@H]2CC[C@@H](C1)N2C)C[C@@](C)(C=C)[C@@H](O)[C@@H]3C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Eligibility criteria:
Inclusion Criteria:

Male or female patients from 9 months of age up to 98 years of age.
Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.
The patient, and if applicable the parent or guardian, is able to give informed consent
Females of child bearing potential have a negative urine pregnancy test.
Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.

Exclusion Criteria:

Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.
Subject who has been enrolled in a clinical trial within the last 30 days.
Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.
Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator
Subjects who have taken oral antibiotics within the last 7 days.
Subjects with known sensitivity to the study medication.
The subject is pregnant or breastfeeding
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
Eligibility criteria:
Inclusion Criteria:

Full thickness rotator cuff tear
Pre operative MRI
Patients who are medically stable to undergo the surgery
Patients who consent to involvement in the study

Exclusion Criteria:

Prior surgery on the involved shoulder
Preoperative MRI suggesting that the rotator cuff tear is unrepairable
Patients with known allergies to oxycodone, bupivacaine or a similar drug
Workman's compensation patients
Patients who do not fill out their visual analog scores or their medication diaries.
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
Eligibility criteria:
Inclusion Criteria:

Full thickness rotator cuff tear
Pre operative MRI
Patients who are medically stable to undergo the surgery
Patients who consent to involvement in the study

Exclusion Criteria:

Prior surgery on the involved shoulder
Preoperative MRI suggesting that the rotator cuff tear is unrepairable
Patients with known allergies to oxycodone, bupivacaine or a similar drug
Workman's compensation patients
Patients who do not fill out their visual analog scores or their medication diaries.