anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Epicatechin
Trial phase: Phase 1
SMILES: Oc1cc(O)c2c(c1)OC(c1ccc(O)c(O)c1)C(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally

(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.
Eligibility criteria:
Inclusion Criteria:

Healthy or pre-diabetic based on medical history
Male or female
Must be 21 to 75 years of age (inclusive)
Able to give informed consent to the procedures
If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
Medication use stable for 4 weeks
Body Mass Index (BMI) > 27 kg/m^2
Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

Exclusion Criteria:

Type 2 diabetes
Pregnancy
Younger than 21 or older than 75 years of age
Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory
Recent MI or stroke (within 6 months of screening)
Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism
Intervention: Epicatechin
Trial phase: Phase 1
SMILES: Oc1cc(O)c2c(c1)OC(c1ccc(O)c(O)c1)C(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.
Eligibility criteria:
Inclusion Criteria:

Healthy or pre-diabetic based on medical history
Male or female
Must be 21 to 75 years of age (inclusive)
Able to give informed consent to the procedures
If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
Medication use stable for 4 weeks
Body Mass Index (BMI) > 27 kg/m^2
Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

Exclusion Criteria:

Type 2 diabetes
Pregnancy
Younger than 21 or older than 75 years of age
Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory
Recent MI or stroke (within 6 months of screening)
Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism
Intervention: PESAMPATOR
Trial phase: Phase 1
SMILES: CC(C)S(=O)(=O)N[C@H]1COC[C@H]1Oc1ccc(-c2ccc(C#N)s2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Eligibility criteria:
Key Inclusion Criteria:

Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).
DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

Key Exclusion Criteria:

Suicide attempt within 3 months prior to screening.
History of or risk of seizures; head injury with long term abnormal resulting condition, abnormal EEG, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: PESAMPATOR
Trial phase: Phase 1
SMILES: CC(C)S(=O)(=O)N[C@H]1COC[C@H]1Oc1ccc(-c2ccc(C#N)s2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Eligibility criteria:
Key Inclusion Criteria:

Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).
DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

Key Exclusion Criteria:

Suicide attempt within 3 months prior to screening.
History of or risk of seizures; head injury with long term abnormal resulting condition, abnormal EEG, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Prednisone
Trial phase: Phase 3
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.

Prednisone: Continuous daily therapy
Eligibility criteria:
Inclusion Criteria:

First episode of ITP

Exclusion Criteria:

Pregnancy
Glucocorticoid intolerance
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).

Dexamethasone: 4-day pulses every 3 weeks
Eligibility criteria:
Inclusion Criteria:

First episode of ITP

Exclusion Criteria:

Pregnancy
Glucocorticoid intolerance
Intervention: 9-(4-Phenoxyphenyl)-3,4-dihydropyrido(2,1-c)(1,2,4)thiadiazine 2,2-dioxide
Trial phase: Phase 1
SMILES: O=S1(=O)CCN2C=CC=C(c3ccc(Oc4ccccc4)cc3)C2=N1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-137 10 mg, tablets, orally, once on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose.
Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.

Exclusion Criteria:

Has a known hypersensitivity to any component of the formulation of TAK-137.
Has a medical condition such as mental retardation that can cause cognitive impairment.
Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the previous 6 months).
Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
There is any finding in the participant's medical history, physical examination, or safety laboratory tests (including safety electroencephalogram [EEG]) giving reasonable suspicion of a disease that would contraindicate taking TAK-137, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
Intervention: CEFTAROLINE FOSAMIL
Trial phase: Phase 1 | Phase 2
ATC code: J01DI02
SMILES: [H][C@]12SCC(Sc3nc(-c4cc[n+](C)cc4)cs3)=C(C(=O)[O-])N1C(=O)[C@H]2NC(=O)/C(=N\OCC)c1nsc(NP(=O)(O)O)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.

Ceftaroline Fosamil: IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive).
Eligibility criteria:
Inclusion Criteria:

Informed consent in writing from parent(s) or other legally acceptable representative(s) and assent from subject (if appropriate according to local requirements)
Male or female 1 to 17 years of age, inclusive.
Suspected hematogenous S.aureus osteomyelitis in a large bone (upper or lower extremities, pelvis) based on clinical findings and radiology results.
One to three site(s) of osteomyelitis with expectation that transition to oral antibiotics from IV therapy will be likely prior to discharge to complete antibiotic therapy. The second or third site might be contiguous like a proximal tibia and distal femur but could also be at sites unrelated such as a distal femur and pelvic bone.
Female subjects who have reached menarche must have a negative urine pregnancy test.
Female subjects who have reached menarche and are sexually active must be willing to practice sexual abstinence or dual methods of birth control during treatment and for at least 28 days after the last dose of any study drug.
Sufficient IV access to receive medication.

Exclusion Criteria:

Received more than 24 hours of IV antibiotics prior to enrollment
More than one bone infected
Disseminated infection or is admitted to the pediatric intensive care unit
Underlying condition (excludes mild eczema or reactive airways disease)
Suspected venous thrombosis or concern for endocarditis
Requirement for other reasons for another antibiotic potentially active against organisms commonly causing osteomyelitis in children.
Creatinine clearance less than 50 mL/min/1.73m2 (calculated by the Schwartz formula)
Liver transaminases greater than 3 times the upper limit of normal
Neutropenia (less than 500 neutrophils/mm^3
Thrombocytopenia (less than 50,000 platelets/mm^3)
Females who are currently pregnant or breast feeding
Hypersensitivity reaction to any Beta-lactam antibiotic
Has had an allergic reaction to ceftaroline in the past
Intervention: Flortaucipir F-18
Trial phase: Phase 1
ATC code: V09AX07
SMILES: Fc1ccc(-c2ccc3c(c2)[nH]c2ccncc23)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Eligibility criteria:
Inclusion Criteria:

Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered

Exclusion Criteria:

Subjects who have withdrawn informed consent
Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Intervention: Hydroxyurea
Trial phase: Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria on at least 2 blood tests over eight weeks prior to dose increase.

hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores
Eligibility criteria:
Inclusion Criteria:

Diagnosis of HbSC disease
Score equal or lower than 80 on the PedsQL™ Sickle Cell Disease Module version 3.0
Have experienced a sickle cell disease related complication

Exclusion Criteria:

Failure to meet inclusion criteria.
Hydroxyurea usage in the last 3 months.
Chronic RBC transfusion therapy.
Packed red blood cell transfusion in the last 3 months (temporary exclusion).
Pregnancy, or refusal to use medically effective birth control if female and sexually active.
Intervention: Amisulpride
Trial phase: Phase 3
ATC code: N05AL05
SMILES: CCN1CCCC1CNC(=O)c1cc(S(=O)(=O)CC)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 572
Group description: Single dose of IV APD421

APD421
Eligibility criteria:
Inclusion Criteria:

Male or female patients ≥ 18 years of age
Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure
Patients with at least 3 "Apfel" risk factors for PONV

Exclusion Criteria:

Patients scheduled to undergo transplant surgery
Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
Patients who are expected to remain ventilated for a period after surgery
Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
Intervention: Ursolic Acid
Trial phase: Phase 2
SMILES: [H][C@]12CC=C3[C@@](C)(CC[C@@]4(C(=O)O)CC[C@@H](C)[C@H](C)[C@@]34[H])[C@]1(C)CC[C@@]1([H])C(C)(C)[C@@H](O)CC[C@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks

Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
Eligibility criteria:
Inclusion Criteria:

Informed consent signed
Patients both sexes
Age between 30 and 60 years
Metabolic Syndrome according to the IDF criteria:
Waist circumference Man ≥90 cm, Woman ≥80 cm; and two of the following criteria:
High density lipoprotein Man ≤40 mg/dL, Woman ≤50 mg/dL;
Fasting glucose ≥100 mg/dL;
Triglycerides ≥150 mg/dL;
Blood pressure ≥130/85 mmHg

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to ursolic acid o calcined magnesia
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Previous treatment for the metabolic syndrome components
Body Mass Index ≥39.9 kg/m2
Fasting glucose ≥126 mg/dL
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg
Intervention: Dapa
Trial phase: Phase 3
SMILES: CC([NH3+])C([NH3+])CCCCCC(=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Dapagliflozin- 10 mg once daily before first meal for 24 weeks

DAPA: 10 mg dapagliflozin QD for 20-24 weeks
Eligibility criteria:
Inclusion Criteria:

• Overweight/obese (BMI >25) females 18 years to 45 years of age, who experienced gestational diabetes (GDM) during recent (within 12 months) pregnancy

postpartum metabolic abnormalities determined by a 75 g oral glucose tolerance test (Inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum)
Completed lactation
Using adequate contraception during study period unless sterilized
Written consent for participation in the study

Exclusion Criteria:

Cholestasis during the past pregnancy
Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance
Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR <60)
Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)
Untreated or poorly controlled hypertension (sitting blood pressure >160/95mm Hg)
Prior history of a malignant disease requiring chemotherapy
Known hypersensitivity or contraindications to use of insulin sensitizers such as metformin or thiazolidinediones
History of hypersensitivity reaction to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions)
Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors or weight loss medications (prescription or OTC)
Uncontrolled thyroid disease (documented normal TSH) or hyperprolactinemia
Liver enzymes (serum alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] ) levels exceeding more than twice normal lab values
Use of drugs known to exacerbate glucose tolerance
History of diabetes or prior use of medications to treat diabetes except GDM
Currently lactating
Eating disorders (anorexia, bulimia) or gastrointestinal disorders
Suspected pregnancy (documented negative serum pregnancy test within 72 hours before first dose of study drug), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months
Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol or history of alcoholism
Patient not willing to use adequate contraception during study period and up to 4 weeks after last dose of study drug (unless sterilized).
Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables
Inability or refusal to comply with protocol
Not currently participating or having participated in an experimental drug study in previous three months
Intervention: Ledipasvir and sofosbuvir
Trial phase: Phase 4
ATC code: J05AP51
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COC(=O)NC(C(=O)N1CC2(CC2)CC1c1ncc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5nc(C6C7CCC(C7)N6C(=O)C(NC(=O)OC)C(C)C)[nH]c5c4)ccc2-3)[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 600
Group description: Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Eligibility criteria:
INCLUSION CRITERIA:

Male or female at least 18 years of age at time of screening who is determined to be eligible based on evaluation by a treating provider,
Documentation of genotype 1 (GT-1) infection, liver fibrosis staging by any AASLD/IDSA guideline approved measurement, and HIV status determination.
Chronic HCV genotype-1 infection prior to study enrollment. Chronic HCV-infection is defined as the following: positive for anti-HCV Ab or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening
Compensated liver disease, both with and without cirrhosis, as determined clinically by referring provider
If coinfected with HIV, stable HIV disease as determined by a treating provider
Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.

EXCLUSION CRITERIA:

Women who are pregnant or breastfeeding

Screening laboratory analyses showing any of the following abnormal laboratory results:

- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min as estimated by the Modification of Diet in Renal Disease (MDRD) equation (utilized by LabCorp):

eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)

Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.
Intervention: Desoximetasone
Trial phase: Phase 4
ATC code: D07AC03 | D07XC02
SMILES: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1(F)[C@@H](O)C[C@]1(C)[C@@H](C(=O)CO)[C@H](C)C[C@@]21[H]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 129
Group description: Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days

Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Eligibility criteria:
Inclusion Criteria:

Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria:

Has other dermatological conditions that may interfere with clinical assessments
Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
History of an adverse reaction to Cortrosyn™ or similar test reagents
Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Atorvastatin 40 mg/day for three months
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed osteoporosis (T score ≤ -2.5 SD at either the lumbar spine or femoral neck)
LDL-cholesterol ≥ 130 mg/dl

Exclusion Criteria:

History of bone fractures,
Clinical evidence of atherosclerotic disease
CKD (stage III-V),
Liver disease
COPD
Rheumatic disorders;
Current or previous treatment with statins, steroids, hormonal replacement therapies, and antiosteoporotic drugs (including vitamin D and calcium supplementation)