anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Saline will be used instead of trimethaphan during insulin clamp

Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
Eligibility criteria:
Inclusion Criteria:

For lean subjects:
21 subjects aged 18-60 yr.
All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
Body mass index < 25Kg/m^2 .
Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.
For Obese subjects with metabolic syndrome:
21 subjects aged 18-60 yr.
All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
Body mass index > 30Kg/m^2.

Participants will be enrolled if they met at least three of the following criteria for metabolic syndrome (Expert panel, Jama 2001):

Waist circumference >102 cm in men and >88 cm in women
High fasting blood sugar (>110 mg%)
Triglyceride levels >150 mg%
Low HDL cholesterol (<40 mg% for men; <50 mg% for women)
High blood pressure (systolic=130 and diastolic = 85 mmHg) • Female volunteers of childbearing potential will undergo serum HCG pregnancy test at screening and urine HCG pregnancy test again on the study day.

Exclusion Criteria:

Pregnant females
Subjects unable to give voluntary informed consent
Subjects on anticoagulant drugs or anemic (anemia defined as Hcto less than 35%)
Subjects with a recent medical illness documented by physicians's visit or detected during the screening visit.
Subjects with a history of coronary heart disease.
Subjects with known kidney or liver disease.
Subjects with recent weight loss or consuming low carbohydrate diet.
Intervention: Vitamin E
Trial phase: Not Applicable
SMILES: Cc1c(C)c2c(c(C)c1O)CC[C@@](C)(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)O2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 1500 units daily for 16 weeks

Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Normal health status except for allergic asthma
Physician diagnosis of mild allergic asthma
Positive allergen skin tests to common aeroallergens

Exclusion Criteria:

Use of systemic or high doses of inhaled corticosteroids, >840 mcg of inhaled beclomethasone of its equivalent (as defined in the consensus report (6))
Past history of severe asthma (as defined in the consensus report (6))
History of asthma exacerbation within the past month
History of recent upper respiratory infection within the past month
Active immunotherapy for allergic diseases
Significant disease other than allergic asthma and allergic rhinitis, such as coronary disease, hypertension, renal failure, anemia, immunodeficiency, cancer, diabetes
Present or remote tobacco smoking
Use of Over The Counter drugs including acetaminophen and pseudoephedrine, herbs, or vitamins
Psychiatric illness that would make adherence to protocol difficult
Inability to give informed consent
Nursing or pregnant women
Woman planning to become pregnant during the study or not using adequate birth control methods (barrier or hormonal methods)
H/o sensitivity to tocopherol-derivatives or medications used during bronchoscopy
Inability to comply with the research protocol
Intervention: Solifenacin
Trial phase: Not Applicable
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Number of subjects that were in compliance with the study protocol and took medication for at least one month.
Eligibility criteria:
Inclusion Criteria:

Men diagnosed with prostate cancer undergoing robotic radical prostatectomy
Incontinence
Obesity
Large prostate weight
Mild and severe AUA symptom scores
Urinary Bother

Exclusion Criteria:

Contra-indication to Solifenacin
Narrow angle glaucoma
Hepatic impairment
Renal impairment
CYP3A4 inhibitors (e.g. Ketoconazole)
Gastric Retention (delayed or slow emptying of the stomach)
Intervention: Novolog mix 70/30
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Intranasal Insulin was administered in either first or second intervention period.
Eligibility criteria:
Inclusion Criteria:

Patients with Early Alzheimer's disease

Exclusion Criteria:

Patients with Late Alzheimer's disease
Intervention: Phenytoin
Trial phase: Phase 4
ATC code: N03AB02 | N03AB52
SMILES: O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Phenytoin target dose of 5 mg/kg qhs
Eligibility criteria:
Inclusion Criteria:

Anticipating a 10-15% drop-out rate, we will induct 30 neurologically normal subjects (age 18 (21) -60) to obtain 25 evaluable subjects who are legally licensed to drive in their state of residence and have been actively driving under appropriate legal guidelines for at least 5 years (to minimize performance variations of novice drivers).
Because this study is intended to determine the potential effects of phenytoin on driving performance, a relatively healthy cohort of patients must be chosen. Chronic medical or psychiatric conditions could cause significant alterations in driving performance independent of those caused by phenytoin, which would complicate interpretation of performance impairments.

Exclusion Criteria:

Subjects who are younger than 18 or older than 60
Have history of prior seizures, family history of epilepsy, or prior history of head injury
Have a known history of prior drug or alcohol abuse or unwillingness to abstain from drug or alcohol use during the study period
Have a past or current active neurological or psychiatric disorder that could impair cognitive or driving performance (i.e. baseline IQ < 90, dementia, mental retardation, stroke, severe head injury, schizophrenia, active clinical depression, progressive brain tumor).
Subjects who have a chronic medical condition (i.e. diabetes mellitus, renal insufficiency, congestive heart failure, hepatic dysfunction, hematologic condition, HIV)
Taking medications known to affect the central nervous system (i.e. baseline pre-study treatment with antiepileptic drug, anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, narcotics and tranquilizers)
Regularly use over-the-counter cough suppressants, antihistamines, or sleep aids; or who ingest over 7 cups of daily coffee or currently smoke cigarettes.
Subjects will be excluded if they cannot complete SIREN testing or neuropsychological instruments because of visual or hearing impairment (history or screening discovery of corrected visual acuity of less than 20/50) or other physical disability, or if they have a history of severe motion sickness as an adult-a marker for patients who develop simulator sickness and therefore cannot participate in SIREN testing.
Intervention: Inosine
Trial phase: Phase 2 | Phase 3
ATC code: D06BB05 | G01AX02 | S01XA10
SMILES: O=c1[nH]cnc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: iNO administration

inhaled nitric oxide : inhaled 80ppm for duration of surgery.
Eligibility criteria:
Inclusion Criteria:

Patients > 19 yr of age scheduled to undergo liver transplantation.

Exclusion Criteria:

Patients < 19 yr of age
Patients undergoing re-transplantation or dual organ transplantation
Patients with underlying pulmonary complications
Intervention: Nitrogen
Trial phase: Phase 2 | Phase 3
ATC code: V03AN04
SMILES: N#N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Placebo (nitrogen)

nitrogen gas : inhaled
Eligibility criteria:
Inclusion Criteria:

Patients > 19 yr of age scheduled to undergo liver transplantation.

Exclusion Criteria:

Patients < 19 yr of age
Patients undergoing re-transplantation or dual organ transplantation
Patients with underlying pulmonary complications
Intervention: Modafinil
Trial phase: Not Applicable
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: 10
Group description: Participants received single oral dose of modafinil (400mg) every morning for 16 days
Eligibility criteria:
Inclusion Criteria:

Male or female individuals, ages 18-65, meeting current DSM-IV criteria for cocaine dependence. Documented positive urine toxicology screen for cocaine at intake and regular 3 times more weekly use of cocaine.
Subject has voluntarily given informed consent and signed the informed consent document(s).
Able to read English and complete study evaluations.

Exclusion Criteria:

Use of prescription medication in the past 6 months indicating a medical or psychiatric condition that in the opinion of the PI would interfere with study participation (e.g. hypertension, severe renal or hepatic disease, HIV, primary psychotic disorder, primary mood disorder, primary sleep disorder).
Meeting DSM-IV criteria for dependence on any substance other than cocaine and nicotine.
Significant underlying medical or psychiatric conditions or hypersensitivity to modafinil that in the opinion of the PI would interfere with study participation.
Abstinence from cocaine for more than one week prior to inpatient admission.
Positive urine or serum pregnancy test.
Women who are pregnant or lactating, or not using a reliable method of birth control.
(For subjects completing the fMRI portion of the study) Presence of or history indicative of ferromagnetic metal in their bodies.
Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
Eligibility criteria:
Inclusion Criteria:

Male or female patients 18 - 65 years of age
Recipients of deceased or living donors
Patients who had undergone primary liver transplantation at least 6 months before enrolment
Recurrent Hepatitis C viral infection and histologically confirmed liver fibrosis (stage I-IV in the Ishak-Knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
Patients receiving tacrolimus or cyclosporine micro-emulsion with or without - Mycophenolic acid (MPA), with or without steroids.
Absence of acute rejection episodes within the previous 6 months to the date of enrolment
Patient in whom an allograft biopsy will not be contraindicated
Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
Patients with Hepatocellular carcinoma (HCC) within the University California, San Francisco (UCSF) Criteria and no recurrence for at least 18 months after OLT.

Exclusion Criteria:

Recipients of multiple organ transplants or patients who have undergone retransplantation
Current biliary complications
History of drug or alcohol abuse within 1 year before enrolment
Patients treated with anti-hepatitis C virus treatment at the time of enrollment or within the previous month to the date of enrolment
Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
Patients with Leukocyte count (WBC) < 3000/mm3, platelet count < 75000/mm3 or Hemoglobin (Hb) < 8 g/dl
Patients with proteinuria >1g/24 hours
Patient with a current severe systemic infection

Other protocol defined inclusion/exclusion criteria may apply.
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Subjects will receive omeprazole 40 mg daily for 30 days
Eligibility criteria:
Inclusion Criteria:

Women at least 5 years past menopause, defined as the last date of menses

Exclusion Criteria:

Allergy/Intolerance to orange juice
Allergy/Intolerance to omeprazole or other PPI therapy
Use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin & tacrolimus
Use of antacids, PPI or H2-blocker therapy within the past two months
Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's Disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute
Use of medications known to interfere with calcium metabolism, including oral steroids or anticonvulsants
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

capsule the night before surgery
capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery
Eligibility criteria:
Inclusion Criteria:

Age at least 18 years
Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included)
Have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

History of bleeding disorders
History of liver or kidney dysfunction
History of allergy to sulfa containing medications
History of lactose intolerance
History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs
Women who are currently pregnant, nursing, or trying to conceive
History of allergy or intolerance to acetaminophen or hydrocodone
History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib.
PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits.
History of cardiovascular disease
Patients currently taking celecoxib
Intervention: Ipratropium
Trial phase: Not Applicable
ATC code: R01AX03 | R03AL01 | R03AL02 | R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 141
Group description: levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)

ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
Eligibility criteria:
Inclusion Criteria:

18-45 years of age
history of asthma
FEV1 > 50% of predicted for their height, age, gender and race upon presentation to the ED
no other cause of wheezing or shortness of breath except for asthma as determined by the Investigator
no history of glaucoma
no Ipratropium or other anticholinergics within 6 hours of study

Exclusion Criteria:

subjects who, in the investigator's opinion, have life-threatening asthma requiring emergent intervention precluding the ability to complete the treatments during the treatment period
based upon history or physical exam in the ED orClinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
subject with a known sensitivity to levalbuterol or racemic albuterol
known 20 pack year smoker
use of ipratropium 6 hours prior to presenting to the ED
subject who may be pregnant or is pregnant es evidenced by pregnancy test
Intervention: Ipratropium
Trial phase: Not Applicable
ATC code: R01AX03 | R03AL01 | R03AL02 | R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 141
Group description: ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses

ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
Eligibility criteria:
Inclusion Criteria:

18-45 years of age
history of asthma
FEV1 > 50% of predicted for their height, age, gender and race upon presentation to the ED
no other cause of wheezing or shortness of breath except for asthma as determined by the Investigator
no history of glaucoma
no Ipratropium or other anticholinergics within 6 hours of study

Exclusion Criteria:

subjects who, in the investigator's opinion, have life-threatening asthma requiring emergent intervention precluding the ability to complete the treatments during the treatment period
based upon history or physical exam in the ED orClinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
subject with a known sensitivity to levalbuterol or racemic albuterol
known 20 pack year smoker
use of ipratropium 6 hours prior to presenting to the ED
subject who may be pregnant or is pregnant es evidenced by pregnancy test
Intervention: Risperidone
Trial phase: Phase 2 | Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
Eligibility criteria:
Inclusion Criteria:

Willingness to participate and written informed consent obtained from parent and when indicated by subject
Confirmed DSM-IV-TR diagnosis of Autistic Disorder or Asperger's Disorder using the ADOS and the ADI-R, the current gold standards for diagnosing autism spectrum disorders, subject history, and clinical consensus with PI. The ADI-R and ADOS will be administered by research-reliable clinicians, including a clinical psychologist, a certified trainer on the ADOS and the ADI-R
rated by study clinician as at least "moderate" on the CGI-Severity scale (a rating of ≥ 4) and greater than 18 on the ABC Irritability subscale

Males or females of any race between 4 and 18 years of age (5) A nonverbal IQ greater than or equal to 55 on the Stanford-Binet:V (6) Women of childbearing potential must use an adequate method of contraception throughout the study.

Exclusion Criteria:

Primary diagnosis of bipolar disorder, schizophrenia, or autism spectrum disorder other than Autistic and Asperger's Disorders
Nonverbal IQ lower than 55 (Stanford-Binet:V)
History of seizure activity in the past year (active seizures might confuse efficacy ratings)
fever, infection, metabolic disturbance or any severe medical illness in the past year
typical or atypical antipsychotic use within 8 weeks of study entry
Inability of parents or care takers to give informed consent, travel to the visits, administer medication, or arrange for completion of rating scales. Other non-antipsychotic medications and non-pharmacological treatments will be allowed if started at least 2 months prior to the initial screening and must remain constant for the 8 weeks of this study. These treatments will be recorded as will a history of past trials of medications. Prohibiting ongoing treatment would be difficult to justify to parents and to the IRB and would make adequate recruitment for this pilot study difficult.
Intervention: Naproxen
Trial phase: Phase 2
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.
Eligibility criteria:
Inclusion Criteria:

Male or female of any race, >18 years of age and have BMI ≤39 kg/m2
Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month)
Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

Exclusion Criteria:

Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
Osteoporotic compression fracture within the last 6 months
Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
Patients receiving acetaminophen only to manage their chronic low back pain
Any uncontrolled or untreated chronic disease
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: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

Previous reaction to memantine