anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Galantamine
Trial phase: Phase 4
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Alzheimer-type dementia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV-TR) and a diagnosis of possible or probable Alzheimer-type dementia, according to NINCDS-ADRDA classification (American Psychiatric Association, 2000
McKhann, G. et al, 1984)
should have moderate dementia, evidenced by a Mini-Mental Status examination (MMSE) score between 12 and 20, including these limits
At inclusion, a recent CT or MRI must be available
Physical examination and the electrocardiogram (ECG) performed at the screening visit must be normal or consistent with the underlying illness in the study population
History of sleep behavior changes (eg: insomnia, daytime sleepiness, changes in sleep/wakefulness cycle) 2 or more weeks before, reported by the caregiver
Patients should have a caregiver sufficiently informed of their condition and, if possible, living with them
Patients (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

History of other neurodegenerative disorders, such as Parkinson's disease, Pick disease or Huntington's chorea, Down syndrome, Creutzfeldt-Jakob disease (patients with mild extrapyramidal signs for which no treatment is required are not excluded from the trial)
Clinically significant cardiovascular disease expected to limit the ability of the patient to participate and complete the study
Any history of epilepsy or seizures (except for febrile seizures in childhood)
Clinically significant psychiatric condition, according to the DSM-IV criteria, particularly major depression or schizophrenia currently
Active peptic ulcer (treatment of the disease started < 3 months or treatment is not successful
Clinically significant liver, renal, pulmonary, metabolic, or endocrine disorders
Clinically significant urinary flow obstruction
History of or suspected alcoholism or drug abuse in accordance to the DSM-IV criteria, in the past year, or previous history of prolonged abuse
Previous therapy with memantine or an acetylcholinesterase inhibitor (including galantamine)
Patients receiving antipsychotics, hypnotic or sedative agents (those patients who need this kind of medication during the study would be withdrawn from the study and replaced)
Bedridden patients
Intervention: Fentanyl
Trial phase: Phase 2 | Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Fentanyl given intranasally in the OR without any pre-medication.
Eligibility criteria:
Inclusion Criteria:

functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

history of allergy to either dexmedetomidine or fentanyl
concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Intervention: Lipoic acid
Trial phase: Phase 2 | Phase 3
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 28 subjects receive oral lipoic acid 1200mg daily

lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SPMS
Age 40-70 years
Able to understand English and able to give informed consent

Exclusion Criteria:

Unable to undergo MRI testing
For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
Pregnant or breast-feeding.
Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
Other immunosuppressants or chemotherapies taken in the last 12 months
Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
IV or oral steroids taken in the past 60 days.
Lipoic acid taken in the past 60 days.
Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
Intervention: Riboflavin
Trial phase: Phase 3
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Eyes in the control group will be treated with riboflavin only.
Eligibility criteria:
Inclusion Criteria:

12 years of age or older
Having a diagnosis of keratoconus
Presence of central or inferior steepening
Topography consistent with keratoconus
Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
Contact lens wearers only:Removal of contact lenses for the required period of time
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
Corneal pachymetry ≤ 400 microns
Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Intervention: Topiramate
Trial phase: Phase 3
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255
Eligibility criteria:
Inclusion Criteria:

Have completed the maintenance period of the P09-004 study.
Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
Intervention: ZINC SULFATE
Trial phase: Not Applicable
ATC code: A12CB01 | B05XA18 | C05AX04
SMILES: O=S(=O)([O-])[O-].[Zn+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: Outpatients with diarrhea will be randomized to zinc sulfate

Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.

For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
Eligibility criteria:
Inclusion Criteria:

Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
Symptoms must be present for greater than 24 hours but less than 72 hours.
Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6 months), Diabetes may be enrolled in the study.

Exclusion Criteria:

Children with symptoms less than 24 hours
Children with symptoms greater than 24 hours
Failure to thrive
G or J tube
Major surgery within last 3 months
Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
Developmental delay, patient >1 year behind milestones
Current brain tumor
Currently being treated for cancer or in remission < 6 months
Intussuception
Antibiotics in the last 14 days or currently taking antibiotics for any reason
Autism
Children born premature <33 weeks
Cystic Fibrosis
Major congenital Heart Disease (any disease where child's baseline oxygen saturations <93%)
Short Gut
Liver disease
History of bowel resection
Intervention: ZINC SULFATE
Trial phase: Not Applicable
ATC code: A12CB01 | B05XA18 | C05AX04
SMILES: O=S(=O)([O-])[O-].[Zn+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate

Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.

For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
Eligibility criteria:
Inclusion Criteria:

Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
Symptoms must be present for greater than 24 hours but less than 72 hours.
Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6 months), Diabetes may be enrolled in the study.

Exclusion Criteria:

Children with symptoms less than 24 hours
Children with symptoms greater than 24 hours
Failure to thrive
G or J tube
Major surgery within last 3 months
Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
Developmental delay, patient >1 year behind milestones
Current brain tumor
Currently being treated for cancer or in remission < 6 months
Intussuception
Antibiotics in the last 14 days or currently taking antibiotics for any reason
Autism
Children born premature <33 weeks
Cystic Fibrosis
Major congenital Heart Disease (any disease where child's baseline oxygen saturations <93%)
Short Gut
Liver disease
History of bowel resection
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
Eligibility criteria:
Inclusion Criteria:

Must have relapsing MS
Must have lifetime tetanus vaccination
Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection

Exclusion Criteria:

Patients with a type of MS that is not relapsing
Patients with history of chronic immune disease
Certain cancers
Diabetic patients with certain eye disorders
Patients who are on certain immunosuppressive medications or heart medications
Patients with certain heart conditions
Patients with certain lung conditions
Patients who have already received the 2010/2011 seasonal influenza vaccine

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4083
Group description: Open-label fingolimod 0.5 mg, taken orally once daily
Eligibility criteria:
Key Inclusion Criteria:

- Patients who have completed selected ongoing or planned trials with FTY720.

Key Exclusion Criteria:

Premature permanent discontinuation of a previous fingolimod study.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:

Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
History or presence of a third degree AV block
Proven history of sick sinus syndrome or sino-atrial heart block
Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

Any of the following pulmonary conditions during the previous fingolimod study:

Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
Active tuberculosis
Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
Intervention: Difluprednate
Trial phase: Phase 3
ATC code: D07AC19
SMILES: [H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
Eligibility criteria:
Inclusion Criteria:

Diagnosis of endogenous anterior uveitis in at least 1 eye.
The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
Age 2 years or older on day of consent.
Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
History of steroid-induced elevation of intraocular pressure.
Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
Corneal abrasion or ulceration in either eye.
Pregnancy or lactation.
Other protocol-defined exclusion criteria may apply.
Intervention: GLYCOPYRRONIUM
Trial phase: Phase 3
ATC code: A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 473
Group description: NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
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: Imiquimod
Trial phase: Phase 4
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
Eligibility criteria:
Inclusion Criteria:

Male and female adults; 18 and over
At least 10 and no more than 30 clinically typical actinic keratoses on the face

Exclusion Criteria:

Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
Known contraindication to treatment with imiquimod or photodynamic therapy
Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
Systemically immunocompromised
Pregnant or nursing
Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment
Participation in another clinical study

Treatment within the past 60 days with:

Ultraviolet therapy
Systemic immunomodulators
Chemotherapeutic or cytotoxic agents
Investigational agents

Treatment on the head within the past 60 days with:

Imiquimod
Photodynamic therapy
Red or blue light source therapy
Cryotherapy or chemotherapy
Surgical excision or curettage
Topical corticosteroids
Laser
Dermabrasion
Chemical peel
Topical retinoids
Topical 5-fluorouracil
Topical pimecrolimus or tacrolimus
Topical diclofenac
Treatment for actinic keratoses on the head within the past 60 days
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: sulfonylurea plus metformin
Eligibility criteria:
Inclusion criteria:

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: alpha-glucosidase inhibitor plus metformin
Eligibility criteria:
Inclusion criteria:

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs
Intervention: Sitaxentan
Trial phase: Phase 3
ATC code: C02KX03
SMILES: Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)Nc1onc(C)c1Cl)OCO2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
Eligibility criteria:
Inclusion Criteria:

Subject who completed the B1321052 study as planned.

Exclusion Criteria:

Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.