anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Testosterone
Trial phase: Phase 3
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: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
Eligibility criteria:
Inclusion Criteria:

Hypogonadal males with a qualifying general medical health who have Completed the MTE08 trial up to and including Day 120/121 in a compliant manner
Were able to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; were willing to follow the Protocol requirements and comply with Protocol restrictions and procedures

Exclusion Criteria:

Any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject

Any man in whom testosterone therapy was contraindicated, which included those with:

Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a International Prostate Symptoms Score (IPSS) score of greater than or equal to 19
Known or suspected carcinoma (or history of carcinoma) of the breast
Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests >2 times the upper limit of the normal range values
Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions
Current significant cerebrovascular or coronary artery disease
Untreated sleep apnoea
Haematocrit of >54%
Untreated moderate to severe depression
Men with clinically significant prostate exam or clinically significant elevated serum Prostate Specific Antigen (PSA) level (> 4 ng/mL) or age adjusted reference range of PSA values
Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
Men with uncontrolled diabetes (Hemoglobin A1c [HbA1c] greater than or equal to 10%)
Subjects intending to have any surgical procedure during the course of the trial
Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
Subjects whose partners are pregnant
Intervention: FLORBETAPIR
Trial phase: Phase 2
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
Eligibility criteria:
Inclusion Criteria:

Subjects may be enrolled if they (inclusion criteria):

Are males or females ≥60 years of age
Meet research diagnostic criteria for Parkinson's disease:

Diagnosis of a parkinsonian syndrome

Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions)
At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes

Supportive criteria for diagnosis of PD (two or more required)

Unilateral onset of symptoms and persistent asymmetry
Rest tremor present
Progressive illness
Excellent response to levodopa with dyskinesias
Levodopa response for 5 years or more
Clinical course of 10 years or more
Have the ability to lie flat and tolerate a 10 minute PET scan.

Exclusion Criteria:

Subjects may not be enrolled if any of the following are present (exclusion criteria):

History of repeated strokes, repeated head injury, definite encephalitis
Use of neuroleptics at onset of symptoms
Sustained remission
Strictly unilateral feature persisting > three years after onset
Significant supranuclear gaze palsy
Cerebellar, pyramidal and early severe autonomic findings
Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB)
Imaging study showing structural abnormality that could explain parkinsonism
Negative response to an adequate levodopa trial
Current clinically significant psychiatric disease that prohibits providing informed consent or participation in the study
Current clinically significant endocrine or metabolic disease, pulmonary,
Women of childbearing potential who are not two or more years post menopausal or surgically sterilized
Have received any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Intervention: Memantine
Trial phase: Phase 3
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: 182
Group description: 20 mg Oral Tablets Once Daily
Eligibility criteria:
Inclusion Criteria:

Outpatients who:

had a primary diagnosis of probable Alzheimer's Disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR) criteria for dementia of the Alzheimer's type
had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE) total score >=5 and <=15 at screening. Before substantial protocol amendment SA04 (dated 7 October 2004) was implemented, the MMSE total score range at screening was >=8 and <=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed patients who had previously had an MMSE score of 16 or 17 to be re-screened >6 months after their initial screening and, if there was documented evidence of cognitive decline, to be enrolled in the study
had a Neuropsychiatric Inventory (NPI) total score >=13 and an NPI agitation/aggression subitem score >=1 at screening and baseline
did not have vascular dementia or a modified Hachinski Ischaemia Scale score >4 at screening

Exclusion Criteria:

Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine
Intervention: Lapatinib
Trial phase: Not Applicable
ATC code: L01EH01 | L01XE07
SMILES: CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years.
Patients with operable, biopsy-proven DCIS detected by screening mammography.
ER/PR negative DCIS.
DCIS that is positive for HER-2 &/or EGFR, which is defined as IHC 3+.
Women of childbearing potential willing to use an accepted and effective barrier method of contraception.
ECOG performance status ≤2
Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
Ability to understand and the willingness to sign a written informed consent document.

Patients must have normal organ and marrow function as defined below:

leukocytes ≥3,000/microL
absolute neutrophil count ≥1,500/microL
platelets ≥100,000/microL
total bilirubin within normal institutional limits
AST (SGOT)/ALT(SGPT) within normal institutional limits
creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault formula)

Exclusion Criteria:

Invasive breast cancer
ER+ or PR+ DCIS
Pregnant or breast feeding women
Patients who have had prior treatment with EGFR targeting therapies.
Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded one week before starting lapatinib and for the duration of lapatinib therapy.
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib.
Have ANY hepatic or biliary disease or dysfunction.
Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
ANY history of cardiac disease.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Normal Saline IV solution - Given by a continuous infusion
Eligibility criteria:
Inclusion Criteria:

Children age 6 months through 17 years of age undergoing interventional neuroradiologic procedures at our hospital under general anesthesia
Patients classify as an ASA (American Society of Anesthesiologists) I-III
Have not received anesthetic for over 30 days from previous procedures

Exclusion Criteria:

Receiving digoxin therapy from the study
Severe congestive heart failure or pulmonary hypertension requiring vasodilators
Disease processes other than that associated with their intracranial pathology, such as hepatic or renal dysfunction
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: 24
Group description: Nateglinide 90~120mg three times a day

Nateglinide: Nateglinide 90~120mg three times a day
Eligibility criteria:
Inclusion Criteria:

type 2 diabetes mellitus
age>=18years

no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)

6.5% ≤ HbA1c ≤ 8.5%

patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

Exclusion Criteria:

attending other clinical trials in 3months
type I diabetes mellitus
taking systemic steroid in 1month or requiring steroid therapy during clinical trial
acute myocardial infarction in 6months
alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
severe liver disease or AST, ALT ≥ 2.5 x ULN
renal insufficiency (serum creatinine > 2.0mg/dl)
other severe diabetic complication
drug hypersensitivity history to nateglinide or sulfonylurea
pregnant or plan to become pregnant during the clinical trial, lactation
Intervention: Glimepiride
Trial phase: Phase 4
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Glimepiride 1~2mg once a day

Glimepiride: Glimepiride 1~2mg once a day
Eligibility criteria:
Inclusion Criteria:

type 2 diabetes mellitus
age>=18years

no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)

6.5% ≤ HbA1c ≤ 8.5%

patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

Exclusion Criteria:

attending other clinical trials in 3months
type I diabetes mellitus
taking systemic steroid in 1month or requiring steroid therapy during clinical trial
acute myocardial infarction in 6months
alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
severe liver disease or AST, ALT ≥ 2.5 x ULN
renal insufficiency (serum creatinine > 2.0mg/dl)
other severe diabetic complication
drug hypersensitivity history to nateglinide or sulfonylurea
pregnant or plan to become pregnant during the clinical trial, lactation
Intervention: Minocycline
Trial phase: Not Applicable
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: open label minocyline 50 mg or 100 mg PO BID
Eligibility criteria:
Inclusion Criteria:

Diagnosis of FXS by clinical evaluation and confirmed by FMR1-DNA testing with presence of full mutation or mosaicism for the full mutation. Prior DNA testing reports will be accepted, when available.
Age between 13 to 35 years inclusive at the time of informed consent.
Male or female
CGI-Severity Score of 4 or greater, indicative of moderate or greater severity of behavioural problems. This is a 7-point scale of clinical global impression of severity that the clinician fills out after considering all the available information on the patient, including the parent history, the examination in clinic, reports from the school and other sources.
Score of 9 or greater on the Aberrant Behaviour Checklist - Irritability Scale (top 50th %-tile). The ABC is a global behaviour checklist implemented for the measurement of drug and other treatment effects in mentally impaired individuals. It is made up of 5 empirically derived dimensions including irritability, lethargy/withdrawal, inappropriate speech, hyperactivity, and stereotypic behaviour based on 58 items that describe various behavioural problems.
Availability of parent and/or caregiver for all clinic visits and assessments.
English language fluency and reading level of 6th grade or greater in one caregiver.

Exclusion Criteria:

Allergy to minocycline.
Kidney disease or elevated renal function tests.
Liver disease or elevated liver function tests.
Participants with neutropenia, anemia, or thrombocytopenia.
History of systemic lupus erythematosus or screening anti-nuclear antibody (ANA) titre of >1:40, as minocycline may cause a lupus-like reaction.
Individuals who do not have a mother or caregiver who is willing to participate in the clinic visits.
Individuals who are pregnant or at risk to become pregnant, specifically sexually active females will be excluded.
Presence of persistent psychotic symptoms
Subjects with symptom severity likely judged to endanger personal safety or safety of others.
History of systemic lupus erythematosus or screening anti-nuclear antibody (ANA) titre of >1:40, as minocycline may cause a lupus-like reaction.
Intervention: Clonidine
Trial phase: Phase 4
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
Eligibility criteria:
Inclusion Criteria:

Heart failure

Exclusion Criteria:

Currently on Coumadin therapy
Experienced a heart attack in the 3 months before study entry
Medically unable to receive clonidine
Advanced kidney or liver disease
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 147
Group description: Allocated to rifaximin
Eligibility criteria:
Inclusion Criteria:

live in single village

Exclusion Criteria:

acutely malnourished
acutely ill
chronic disease
Intervention: RISEDRONIC ACID
Trial phase: Phase 4
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Particiapnts given 35 mg by mouth every week
Eligibility criteria:
Inclusion Criteria:

Non-metastatic prostate cancer
Men to receive Gonadotropin-releasing Hormone-agonist therapy

Exclusion Criteria:

Other cancers except skin cancer
Evidence of metabolic bone disease
Prior use of bisphosphonates
Intervention: Modafinil
Trial phase: Phase 2
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: 6
Group description: Modafinil 400mg orally once daily
Eligibility criteria:
Inclusion Criteria:

18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).

not currently enrolled in a treatment program
subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.

Exclusion Criteria:

current diagnosis of alcohol, opiate, or sedative physical dependence
ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
history of schizophrenia, or bipolar type I disorder
present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine or desipramine)
current suicidality or psychosis
Liver function tests (i.e., liver enzymes) greater than three times normal levels
pregnancy or breastfeeding
Intervention: Tamsulosin
Trial phase: Phase 3
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 152
Group description: Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Eligibility criteria:
Inclusion Criteria (main):

Age: at least 18 years
CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
A Harvey-Bradshaw score between 5 and 12
Males and non-pregnant, non-nursing women
Mild to moderate active CD, defined by a CDAI score between 180 and 350
Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
Estimated creatinine clearance should be above 75 ml/min

Exclusion Criteria (main):

Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial
CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
Prior treatment resistance to Pentasa (mesalazine)
Chronic, dominant arthralgia or rheumatoid arthritis
Palpable abdominal mass
Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
Positive pregnancy test
Intervention: Promega
Trial phase: Phase 4
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Eligibility criteria:
Inclusion Criteria:

Infants in the newborn intensive care unit
TPN cholestasis of at least 2.5 mg/dl
Anticipated TPN treatment for at least one month
signed informed consent

Exclusion Criteria:

Enrollment in another trial
Lack of consent