anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
Eligibility criteria:
Inclusion Criteria:Subjects with T2DM who are:

naïve to insulin and TZD therapy
On diet and lifestyle therapy along with submaximal metformin therapy
with HbA1c between 7% and 8.0%
between the ages of 18 and 80 years
both genders

Exclusion Criteria:

Contraindications to TZD therapy including congestive heart failure class III or IV, and/or macular edema
history of osteoporosis (T score < -2.5 on DXA scanning) or osteoporotic fragility fracture
treatment with glucocorticoids within 1 year of study enrollment
treatment with bisphosphonates,calcitriol, raloxifene, Calcitonin, estrogen
vitamin D insufficiency, defined as 25(OH)D levels <30 ng/mL or
hyperparathyroidism
liver disease (LFTS > 3x upper limits of normal)
Kidney disease Cr>1.4 in females and Cr>1.5 in males
smokers (active or within a month from stopping)
alcohol or drug abuse/dependence
hypogonadism in males
mental conditions rendering the subject unable to understand the scope of the study
female subjects who are pregnant or breast feeding
chronic obstructive pulmonary disease
obstructive sleep apnea.
Intervention: Tolcapone
Trial phase: Phase 2
ATC code: N04BX01
SMILES: Cc1ccc(C(=O)c2cc(O)c(O)c([N+](=O)[O-])c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Tolcapone 100-300mg/day

Tolcapone : pill, 100-300mg/day for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Men and women age 21-75;
Meet diagnostic criteria for current pathological gambling based on DSM-IV criteria and confirmed using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
Gambling behavior within 2 weeks prior to enrollment;
Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence.

Exclusion Criteria:

Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
History of elevated liver enzymes (AST/ALT) or other liver abnormalities;
History of seizures;
Myocardial infarction within 6 months;
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
A need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator;
Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3);
Current co-morbid Axis I disorder determined by the Structured Clinical Interview for DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence;
Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder determined by SCID;
Clinically significant cognitive impairment (defined as score less than 88 on 3MS);
Current or recent (past 3 months) DSM-IV substance abuse or dependence;
Positive urine drug screen at screening;
Initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline;
Previous treatment with tolcapone;
Treatment with an investigational medication or depot neuroleptics within 3 months;
Refusal to sign the tolcapone information sheet.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | 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: 29
Group description: 5 ml of 7% saline twice daily

Saline: 7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID)
Eligibility criteria:
Inclusion Criteria:

Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
Age 12 or greater
FEV1 > 30% predicted(within the last 14 days and oxygen saturation > 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
Admitted for an exacerbation,
Use of effective contraception in women,
Able to provide written informed consent.

Exclusion Criteria:

Pregnancy,
History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
Hemoptysis more than 60 mL within the last 30 days,
Use of any investigational study drug within the last 30 days,
Initiation of hypertonic saline within the last 30 days,
A serum creatinine 2 mg/dl or more
Active malignancy in the last year
Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
B cepacia colonization
Waiting list for lung transplant
Lack of FEV1 data from the last 14 days
Previous participation in this study
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: Sham Alpha-Stim intervention with real midazolam administration

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
Eligibility criteria:
Inclusion Criteria:

Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
ASA classification I II and III

Exclusion Criteria:

ASA classification IV (patients with a chronic or severe disease).
Hypersensitivity to midazolam or benzodiazepines
acute narrow-angle glaucoma
untreated open-angle glaucoma
Patients with any sort of psychiatric or neurological disorder
Patients on anti-anxiety medication
Patients who have demand-type pacemakers installed before 1999* *Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
Intervention: Nateglinide
Trial phase: Phase 4
ATC code: A10BX03
SMILES: CC(C)[C@H]1CC[C@H](C(=O)N[C@H](Cc2ccccc2)C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed type 2 diabetes mellitus patients
HbA1c > 6.5 and < 9.0%
Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control

Exclusion Criteria:

History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
Liver disease
Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Precose
Trial phase: Phase 4
ATC code: A10BF01
SMILES: CC1OC(OC2C(CO)OC(OC3C(CO)OC(O)C(O)C3O)C(O)C2O)C(O)C(O)C1NC1C=C(CO)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed type 2 diabetes mellitus patients
HbA1c > 6.5 and < 9.0%
Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control

Exclusion Criteria:

History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
Liver disease
Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Increasing dose to 300 mg four times per day (total of 1200 mg/day)
Eligibility criteria:
Inclusion Criteria:

Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

Exclusion Criteria:

Pregnant women
Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
Individuals with intolerance of gabapentin or memantine
Intervention: Memantine
Trial phase: Not Applicable
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
Eligibility criteria:
Inclusion Criteria:

Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

Exclusion Criteria:

Pregnant women
Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
Individuals with intolerance of gabapentin or memantine
Intervention: Benzocaine
Trial phase: Not Applicable
ATC code: C05AD03 | D04AB04 | N01BA05 | R02AD01
SMILES: CCOC(=O)c1ccc(N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
Eligibility criteria:
Inclusion Criteria:

Understanding and voluntary signature (including date) of an informed consent document
Healthy male or female > 18 years of age
Clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the Modified Fitzpatrick Wrinkle Scale (MFWS section 6.5)
Willingness to receive EVOLENCE® injections in areas of aging defects (wrinkles)
Willingness and ability to comply with the requirements of this protocol

Exclusion Criteria:

History of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock
Subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication
Subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection
History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex
Autoimmune or collagen vascular disease, or connective tissue disease
Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry
Previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or EVOLENCE® within 12 months in the treatment area
Currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry
Botulinum-toxin A within 6 weeks in treatment area
Received any investigational products within 30 days prior to the study enrollment
Females of Childbearing Potential
Any clinically significant organic disease or other medical condition that in the opinion of the PI, makes the subject a poor candidate for participation in the study
Intervention: Pasireotide
Trial phase: Phase 2
ATC code: H01CB05
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 80 mg IM once monthly
Eligibility criteria:
Inclusion Criteria:

gonadotroph adenoma

Exclusion Criteria:

visual impairment attributable to the adenoma
radiation therapy
active gallbladder disease
uncontrolled diabetes
Intervention: Rosuvastatin
Trial phase: Phase 2
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Rosuvastatin: 10mg tablets, once daily in three months
Eligibility criteria:
Inclusion criteria:

Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion
COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
Age between 40 and 80 years

Exclusion criteria:

Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)
History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease
History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays
History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)
Body mass index >40kg/m2
History of diabetes mellitus, measured fasting glucose > 11 mmol/L
History of Hypercholesterolemia, measured total cholesterol > 8 mmol/L
Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy
Neutropenia, anemia (Hb < 8 g/100mL)
History of chronic renal failure, serum creatinine > 176 micromol/L (2.0mg/dL)
Creatine kinase > 3 times the upper limit of normal (ULN)
Acute or chronic liver disease (serum transaminases > 3 times the ULN)
Pregnancy (oral examination and blood test prior to inclusion)
Active abuse of drugs or alcohol, poor compliance anticipated
Statin use within the last 4 weeks prior to study start or previously clear indication for statin use
Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin
History of malignant disease of any kind within 5 years prior to inclusion.
History of uncontrolled hypothyroidism
Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion.
Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid
Intervention: PF-04447943
Trial phase: Phase 2
SMILES: C[C@@H]1CN(Cc2ncccn2)C[C@H]1c1nc2c(cnn2C2CCOCC2)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Mild to moderate Alzheimer's disease (MMSE 14-26)
Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria:

Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
Significant cardiovascular disease in the past 6 months
Illness other than Alzheimer's disease that could contribute to cognitive impairment
History of stroke or seizure disorder
Intervention: Ciprofloxacin
Trial phase: Phase 2
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Eligibility criteria:
Inclusion Criteria:

Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or post pneumonic bronchiectasis
Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days

Exclusion Criteria:

Forced Expiratory Volume 1 < 35% or > 80%
Allergic bronchopulmonary aspergillosis
Immunodeficiency disease requiring immunoglobulin replacement
Inflammatory bowel disease
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.

Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol
Eligibility criteria:
Inclusion Criteria:

Age => 18.
Recipient of a deceased donor kidney transplant.
Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis
Stable serum creatinine for 2 weeks prior to enrollment.
Able to give informed consent.
Compliant with medical regimen and clinic visits.

Exclusion Criteria:

Episode of acute rejection within 4 weeks prior to enrollment.
Calculated GFR < 30 ml/min.
Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).
Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.
Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.
Recipient of pancreas or liver allografts.
Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.
Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.
Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.
Unwilling to comply with study protocol.
Enrollment in another drug trial that precludes use of sirolimus.
Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
For women, pregnancy.
Allergy to iodine
Intervention: Nitric Oxide
Trial phase: Phase 3
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 229
Group description: Inhaled Nitric Oxide

Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Eligibility criteria:
Inclusion Criteria:

Preterm infants who are:

500 to 1250 grams at birth
< 30 weeks gestational age
5 to 14 days of age (inclusive) at the time of entry
Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
Subjects who are dependent on right to left shunting to maintain the systemic circulation
Preterm infants who received prior iNO therapy
Use of another investigational agent
Intervention: Tenofovir
Trial phase: Phase 4
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
CD4 count>200
No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
Ability and willingness to provide written informed consent and comply with protocol requirements

Exclusion Criteria:

Prior exposure to raltegravir or elvitegravir
Women who are pregnant, breast-feeding, or with a positive pregnancy test
Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
Life expectancy less than 6 months
Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
Treatment with proton-pump inhibitor or H2-receptor antagonist
ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness