anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Alvimopan
Trial phase: Phase 3
ATC code: A06AH02
SMILES: C[C@H]1CN(C[C@H](Cc2ccccc2)C(=O)NCC(=O)O)CC[C@@]1(C)c1cccc(O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
Eligibility criteria:
Inclusion criteria:

Females at least 18 years of age
Have an American Society of Anesthesiologists (ASA) Score of I to III
Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer
Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication
Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

Exclusion criteria:

Females younger than 18 years of age
Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer.
Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery
Use illicit drugs or abuse alcohol
Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy
Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous bowel movements per week) or chronic diarrhea
Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery
Have chemotherapy or radiation induced bowel dysfunction
Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)
Have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study
Have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery
Have a diagnosis of severe hepatic insufficiency or end stage renal disease.
Have a history of previous surgeries, illness, or behavior that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
Are unable to understand the study procedures and are not able to voluntarily provided informed consent
Intervention: TERIPARATIDE
Trial phase: Phase 4
ATC code: H05AA02
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)O)C(C)C)C(C)C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Open label teriparatide given immediately following surgical repair of fracture

teriparatide: 20 microgram once-daily subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

postmenopausal women
with osteoporosis who have been on bisphosphonate therapy for one year or more (all bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or zoledronic acid).
Patients will also be included if they are on glucocorticoids or other medications known to affect bone mineral metabolism as these are often found in patients with these types of fractures.
sustain an atypical subtrochanteric or diaphyseal femoral shaft fracture as defined by the the 2010 ASBMR task force. An atypical fracture must include all of the following: (1) a location in the femur distal to lesser trochanter; (2) no trauma or minimal trauma as a fall; (3) transverse or short oblique configuration; (4) noncomminuted; and (5) complete fracture extends through both cortices and may be associated with a medial spike; incomplete fractures involve only the lateral cortex. Patients who have an incomplete fracture can be included if they fall into the 2010 ASBMR task force definition.

Exclusion Criteria:

men
children
those who have had radiation therapy
Paget's disease
treatment with teriparatide for two year in the past
metastatic bone disease
active cancer
hypercalcemia
hyperparathyroidism
metabolic disease other than osteoporosis
Intervention: LATANOPROSTENE BUNOD
Trial phase: Phase 2
ATC code: S01EE06
SMILES: O=C(CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O)OCCCCO[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.

BOL-303259-X: Topical ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion Criteria:

Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
Subjects with an irregular daily sleep schedule.
Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
Subjects who are expected to require treatment with ocular or systemic corticosteroids.
Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanationtonometry in either eye.
Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with previous or active corneal disease.
Subjects with a history of severe dry eye.
Subjects with active optic disc hemorrhage.
Subjects with a history of central/branch retinal vein or artery occlusion.
Subjects with a history of macular edema.
Subjects with very narrow angles and subjects with angle closure, congenital, and secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Gabapentin group
Eligibility criteria:
Inclusion Criteria:

scheduled for outpatient tonsillectomy and adenoidectomy
< 60 Kg, between 5th and 95th percentile for weight
ability to self-report pain
complete pain diary with assistance from parent or guardian

Exclusion Criteria:

require pre-anesthesia medication for anxiety
require interpreter for verbal or written communication
Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
ongoing oxygen dependence, pulmonary hypertension
elevated risk of regurgitation
history of seizures
currently taking psychoactive medications or having a psychiatric condition requiring medications
chronic pain disorders requiring medications
renal disease
developmental or cognitive disabilities
history of adverse reactions to components of liquid gabapentin or placebo
Intervention: Prucalopride
Trial phase: Phase 4
ATC code: A06AX05
SMILES: COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
Eligibility criteria:
Inclusion Criteria:

Chronic constipation
Male or female ages 18-75 years
Non-pregnant, non-lactating female

Exclusion Criteria:

Drug-induced constipation
Subjects suffering from secondary causes of chronic constipation, such as:
Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
Surgery.
Subjects with insulin-dependent diabetes mellitus
Rectal evacuation disorder/outlet obstruction
Subjects with intestinal perforation or obstruction
Severe renal impairment
Subjects with a history of alcohol or drug abuse
Subjects with lactose intolerance
Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.

Saline: Sodium Chloride 0.9% intranasal spray
Eligibility criteria:
Inclusion Criteria:

1. Urological indications for cystoscopic procedure.

Exclusion Criteria:

History of analgesia abuse or former opioid addiction.
Allergy to fentanyl.
Acute/chronic nasal problems such as rhinitis or sinusitis.
Positive urine pregnancy test / lactation.
Acute bronchial asthma / upper airway obstruction.
Presence of bradycardia or a history of seizures.
Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and verapamil)
0-10 NRS pain score more than 3 on baseline.
Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.
Intervention: Deferasirox
Trial phase: Phase 1 | Phase 2
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Deferasirox and deferiprone
Eligibility criteria:
Inclusion Criteria:

Alpha or beta thalassemia
Receiving chronic transfusions (at least 20 transfusions in lifetime) with iron overload requiring treatment with chelation
Serum ferritin >500 ng/ml
Liver iron concentration equal to or greater than 10 mg/g dw (by R2 MRI) or 7 to 10 mg/g dw (by R2 MRI) and not improving OR cardiac T2* between 6 and <20 ms
Women of childbearing age must have a negative pregnancy test
Agree to use approved method of contraception for the duration of the study
Subjects must have a good understanding of the study and be willing to comply with study procedures

Exclusion Criteria:

Subjects with past history of unexplained neutropenia (ANC < 1500/mcL), clinically significant renal disease (creatinine above the upper limit of normal), proteinuria >300 mg/L, clinically significant liver disease (ALT > 5x upper limit of normal), pulmonary or cardiovascular disease
History of other clinically relevant oral, endocrine, neurologic, psychiatric, immunologic, bone marrow or skin disorder that contraindicates dosing with deferasirox or deferiprone
History of adverse reaction or known allergy to either deferasirox or deferiprone necessitating drug discontinuation
Currently receiving treatment for active hepatitis
Use of any investigational agent in the past 30 days
Cardiac T2* <6 ms, left ventricular ejection fraction < 56%, and/or arrhythmia (certain subjects may be eligible if they have already had a trial of deferoxamine and deferiprone). Subjects who refuse to use deferoxamine after extensive consultation with at least 2 health care providers will also be allowed to participate.
Pregnant or breastfeeding females
Unwilling or unable to comply with study related procedures
Intervention: Chromium nicotinate
Trial phase: Not Applicable
SMILES: O=C([O-])c1cccnc1.O=C([O-])c1cccnc1.O=C([O-])c1cccnc1.[Cr+3]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period

chromium niacinate: 200ug or 500ug supplementation in pill form
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Type 1 diabetes mellitus
Participants between the ages of 8 and 21

Exclusion Criteria:

Subjects with sickle cell disease, renal or liver disease
Serum positive pregnancy test or breastfeeding
Participants unwilling/unable to take supplements in pill form
Participants taking prescription medication or supplements
Intervention: Tacrolimus
Trial phase: Phase 2 | Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
Eligibility criteria:
Inclusion Criteria:

Recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
Rejection-free post-transplant course for at least 3 months
Renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
Hypertension requiring anti-hypertensive mediations.
Informed consent.
Weight ≥15 kg.

Exclusion Criteria:

Rejection or infections within 3 months of enrollment.
Intent to continue TAC
Active participation in ongoing studies of immunosuppressive agents.
Lack of informed consent.
Pregnant or breast feeding
HIV positive
Intervention: miniICE
Trial phase: Phase 2
SMILES: COc1cc(C2c3cc4c(cc3C(OC3OC5COC(C)OC5C(O)C3O)C3COC(=O)C23)OCO4)cc(OC)c1O.O=C(O)C1(C(=O)O)CCC1.O=P1(NCCCl)OCCCN1CCCl.[CH3-].[CH3-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received the investigator's choice of chemotherapy, dosed per package instructions.
Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria:

Histologic diagnosis of unresectable stage III or IV metastatic melanoma
Prior ipilimumab induction treatment (3 mg/kg)
Documented disease control [Stable Disease ≥3 months or Partial Response/Complete Response] after ipilimumab induction
Documented progressive disease following disease control

Key Exclusion Criteria:

Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
Patients with a prior irAE that has not improved to grade 1 or better at randomization
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Patients randomized to furosemide
Eligibility criteria:
Inclusion Criteria:

Age less than 6 months of age;
Undergoing cardiothoracic surgery with CPB;
Planned placement of PD catheter per institutional standard of care criteria.

Exclusion Criteria:

Pre-existing chronic kidney disease stage 3 or above (correlating with estimated GFR<60 ml/min/m2, which will be calculated using routine preoperative serum creatinine value using the modified Schwartz equation).
Known history of allergy to furosemide.
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 222
Group description: NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
Eligibility criteria:
Inclusion criteria:

Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011).
Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.
Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
Patients with a body mass index (BMI) of more than 40 kg/m2.
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Colchicine
Trial phase: Phase 4
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later

Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later
Eligibility criteria:
Inclusion Criteria:

Patients must be more than 18 years of age and referred for coronary angiography

Exclusion Criteria:

Plan for diagnostic-only coronary angiography
On colchicine chronically
History of intolerance to colchicine
Glomerular filtration rate <30mL/minute or on dialysis
Active malignancy or infection
History of myelodysplasia
High-dose statin load <24 hours prior to procedure
Use of oral steroids or non-steroidal anti-inflammatory agents other than aspirin within 72 hours or 3 times the agent's half-life (whichever is longer)
Use of strong CYP3A4/P-glycoprotein inhibitors (specifically ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil)
Unable to consent
Participating in a competing study
Intervention: Atorvastatin
Trial phase: Phase 3
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: To summary the total adverse event of Lipitor.
Eligibility criteria:
Inclusion Criteria:

Females or males aged between 20 and 80 years.

Subjects who meet All of the following diagnosis at screening visit:

Primary hypercholesterolemia or combined dyslipidemia
TC ≥ 220 mg/dL or LDL-C ≥ 130 mg/dL
TG < 400 mg/dL
Subjects who is willing and able to provide ICF.

Exclusion Criteria:

Females who are pregnant, breast-feeding or intent to be pregnant during study period, or those of childbearing potential not using effective contraception.
Subject with documented homozygous familial hypercholesterolemia.
Subject with documented HIV.
Subject with documented hypothyroidism and inadequate treatment judged by investigator.
Subjects with unstable cardiovascular disease (CVD) prior to randomization.
Subjects with hepatic or biliary disorders, such as acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice.
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Subjects with the following lab data at screening visit:

serum creatine kinase (CK) > 5 x upper limit of normal (ULN)
ALT or AST of > 3 x ULN
serum creatinine ≥ 1.5 mg/dL
HbA1c > 8.0%

Subject with the following past histories:

hypersensitivity to statins or any other ingredients of study drugs
resistant to statins treatment
Use of any lipid-lowering agents within 4 weeks prior to the initiation of study treatment.
Use of any investigational product within 4 weeks prior to screening.
Any unstable concomitant disease or clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study.