anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Darifenacin
Trial phase: Phase 2
ATC code: G04BD10
SMILES: NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Male and female participants ages 2-15 years
Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
Using clean intermittent catheterization (CIC) on a regular basis
Participating in a bowel program on a regular basis
Able to swallow the study medication in accordance to the protocol
Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures

Exclusion Criteria:

Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
Fecal impaction. Participants may be included, once this condition has resolved
Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
Diabetes insipidus
Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
Concomitant diseases, in which the use of darifenacin is contraindicated
History of hypersensitivity to darifenacin or to drugs with similar chemical structures
Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
Female adolescent of child-bearing potential, unless using an acceptable method of contraception
Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Darifenacin
Trial phase: Phase 2
ATC code: G04BD10
SMILES: NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Male and female participants ages 2-15 years
Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
Using clean intermittent catheterization (CIC) on a regular basis
Participating in a bowel program on a regular basis
Able to swallow the study medication in accordance to the protocol
Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures

Exclusion Criteria:

Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
Fecal impaction. Participants may be included, once this condition has resolved
Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
Diabetes insipidus
Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
Concomitant diseases, in which the use of darifenacin is contraindicated
History of hypersensitivity to darifenacin or to drugs with similar chemical structures
Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
Female adolescent of child-bearing potential, unless using an acceptable method of contraception
Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Darifenacin
Trial phase: Phase 2
ATC code: G04BD10
SMILES: NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Male and female participants ages 2-15 years
Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
Using clean intermittent catheterization (CIC) on a regular basis
Participating in a bowel program on a regular basis
Able to swallow the study medication in accordance to the protocol
Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures

Exclusion Criteria:

Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
Fecal impaction. Participants may be included, once this condition has resolved
Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
Diabetes insipidus
Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
Concomitant diseases, in which the use of darifenacin is contraindicated
History of hypersensitivity to darifenacin or to drugs with similar chemical structures
Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
Female adolescent of child-bearing potential, unless using an acceptable method of contraception
Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: PCO-371
Trial phase: Phase 4
SMILES: Cc1cc(N2C(=O)NC(=O)C2(C)C)cc(C)c1CCS(=O)(=O)N1CCC2(CC1)N=C(c1ccc(OC(F)(F)F)cc1)NC2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: PTH (1-84) + placebo alendronate

PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

Previous/current treatment and medical history.
Intervention: ALENDRONIC ACID
Trial phase: Phase 4
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: PTH (1-84) placebo + alendronate

PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

Previous/current treatment and medical history.
Intervention: Nabiximols
Trial phase: Phase 3
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
Eligibility criteria:
Inclusion Criteria:

Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving GW-1000-02 treatment) and had completed the study up to Visit 5
Had complied with all of the study requirements to-date, including the completion of the diary cards
Had shown tolerability to the study medication in this study
Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires

Exclusion Criteria:

Had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study
Intervention: Fludarabine
Trial phase: Phase 2 | Phase 3
ATC code: L01BB05
SMILES: Nc1nc(F)nc2c1ncn2C1OC(CO)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Single Arm Intervention trial as noted in interventions section

Fludarabine: Fludarabine 30 mg/m2/day x 3 days

Total Body Irradiation: TBI 200cGy x1 dose on transplant day

Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
Eligibility criteria:
Inclusion Criteria:

Stage II or III non-progressive disease Multiple Myeloma.
CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
≤ 70 years old.
Eligible and willing HLA matched related donor.
Bilirubin <2xULN.
ALT and AST <3xULN.
LVEF > 40%.
Creatinine Clearance >40mL/min.
Pulmonary function DLCO corrected to ≥ 70%.
Minimum performance score of 70%.
Platelet count >130 x103 micro L.
LDH ≤1.5xULN.
No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
No uncontrolled infections.

Exclusion Criteria:

Age >70 years old.
Performance status <70%.
Uncontrolled infections or is HIV positive
Prior malignancies that are felt to have a <80% probability of being cured.
Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
Prior Allograft
History of rapidly growing disease at diagnosis or at any progression or have MDS.
No eligible and willing HLA matched donor.
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
Eligibility criteria:
Inclusion Criteria:

All subjects must give written informed consent by parent or guardian
Male or female subjects, > 6 - 17 years
Patients must have endoscopic or radiographic confirmed Crohn's Disease.
Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.

Exclusion Criteria:

Adolescent women of childbearing potential and / or sexually active unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
Adolescent women who are pregnant or breastfeeding
Subjects with an ostomy or ileocolic anastomosis from surgery as these operations interfere with the PCDAI assessment
Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be discontinued 4 weeks prior to study initiation.
Patients with abnormal liver function tests
Prednisone greater than 10 mg or > 0.2 mg/kg orally
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 45
Group description: Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Eligibility criteria:
Inclusion Criteria:

Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD
Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia
Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient
Child or adolescent participants must be 10 to 16 years old
Must be able to communicate in English
Must be able to swallow capsules
Be reliable to keep appointments for clinic visits & all related tests
Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia
Participants for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
Females who are pregnant or breastfeeding
Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks
Intervention: Dorzolamide
Trial phase: Phase 4
ATC code: G01AE10 | S01EC03
SMILES: CCN[C@H]1C[C@H](C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt.

dorzolamide: 2% dorzolamide- 1 Gtt TID
Eligibility criteria:
Inclusion Criteria:

Presence of cystic macular fluid on OCT testing

Exclusion Criteria:

Allergic reaction to sulpha containing compounds
Intolerance to dorzolamide (Trusopt)
Intervention: Timolol
Trial phase: Phase 3
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
Eligibility criteria:
Inclusion Criteria:

Male or female of 18 years of age or under
Diagnosis of glaucoma
IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

Require surgery for acute angle closure
Have had prior cyclodestructive procedures
Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
Intervention: Scopolamine
Trial phase: Not Applicable
ATC code: A04AD01 | A04AD51 | N05CM05 | S01FA02
SMILES: CN1C2CC(OC(=O)C(CO)c3ccccc3)CC1C1OC12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Eligibility criteria:
Inclusion Criteria:

Between 18 and 65 years of age
American Society of Anesthesiology (ASA) physical status 1-3
If on oral contraceptive, must be willing to use back up method for 1 month
Must have 2 risk factors for PONV

Exclusion Criteria:

History of vomiting due to middle ear infection, nervous system disorder, or other condition
Procedure less than 1 hour
Pregnant or breast feeding
Antiemetic medication in previous 24 hours
Narrow-angle glaucoma
Allergic to belladonna alkaloids
Hypersensitive to barbiturates
Prostate hypertrophy
Severe hepatic disease
On chemotherapy taking aprepitant
Fever
Sepsis
Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin
Intervention: Levemir
Trial phase: Phase 4
SMILES: CCCCCCCCCCCCCC(=O)NCCCCC(NC(=O)C1CCCN1C(=O)C(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(Cc1ccccc1)NC(=O)C(Cc1ccccc1)NC(=O)CNC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C1CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc2ccc(O)cc2)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(Cc2ccc(O)cc2)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C2CSSCC(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(NC(=O)CN)C(C)CC)C(C)C)C(=O)NC(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)N1)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)N2)C(C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
Eligibility criteria:
Inclusion Criteria:

diabetes mellitus
post-cardiothoracic surgery
requiring an insulin infusion of at least 1 unit/hour
Age 18-75

Exclusion Criteria:

Glucocorticoids
total parenteral nutrition (TPN) or tube feeds
Pregnancy
Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
Expected length of stay less than 48 hours following cessation of the insulin drip
Patients using subcutaneous insulin pumps
Diabetic ketoacidosis
End-stage renal disease
End-stage liver disease
Coma
Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
Unable to give consent in English
Intervention: Levemir
Trial phase: Phase 4
SMILES: CCCCCCCCCCCCCC(=O)NCCCCC(NC(=O)C1CCCN1C(=O)C(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(Cc1ccccc1)NC(=O)C(Cc1ccccc1)NC(=O)CNC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C1CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc2ccc(O)cc2)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(Cc2ccc(O)cc2)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C2CSSCC(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(NC(=O)CN)C(C)CC)C(C)C)C(=O)NC(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)N1)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)N2)C(C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
Eligibility criteria:
Inclusion Criteria:

diabetes mellitus
post-cardiothoracic surgery
requiring an insulin infusion of at least 1 unit/hour
Age 18-75

Exclusion Criteria:

Glucocorticoids
total parenteral nutrition (TPN) or tube feeds
Pregnancy
Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
Expected length of stay less than 48 hours following cessation of the insulin drip
Patients using subcutaneous insulin pumps
Diabetic ketoacidosis
End-stage renal disease
End-stage liver disease
Coma
Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
Unable to give consent in English
Intervention: Levemir
Trial phase: Phase 4
SMILES: CCCCCCCCCCCCCC(=O)NCCCCC(NC(=O)C1CCCN1C(=O)C(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(Cc1ccccc1)NC(=O)C(Cc1ccccc1)NC(=O)CNC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C1CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc2ccc(O)cc2)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(Cc2ccc(O)cc2)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C2CSSCC(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(NC(=O)CN)C(C)CC)C(C)C)C(=O)NC(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)N1)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)N2)C(C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Eligibility criteria:
Inclusion Criteria:

diabetes mellitus
post-cardiothoracic surgery
requiring an insulin infusion of at least 1 unit/hour
Age 18-75

Exclusion Criteria:

Glucocorticoids
total parenteral nutrition (TPN) or tube feeds
Pregnancy
Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
Expected length of stay less than 48 hours following cessation of the insulin drip
Patients using subcutaneous insulin pumps
Diabetic ketoacidosis
End-stage renal disease
End-stage liver disease
Coma
Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
Unable to give consent in English
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
Eligibility criteria:
Inclusion Criteria:

Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

Exclusion Criteria:

Age < 18 or > 85
Admission Glasgow Coma Score (GCS) < 6
ICH volume < 10 cc
ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical
Multiple ICH
Associated Subdural hematoma or significant Subarachnoid hemorrhage
History of prior neurologic disease with modified Rankin Scale (mRS) > 1
Hematoma evacuation, hemicraniectomy, clot lysis
Myopathy
Active Liver disease
Pregnancy
Statin allergy
Patients on statins prior to admission
Patients with an acute indication for statin therapy (Unstable angina)