anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 114
Group description: Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.

Pioglitazone: 30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 35-64
BMI: ≥ 25 and ≤ 40

Exclusion Criteria:

Pregnancy as determined by urine pregnancy test Breast-feeding, or planning to become pregnant during the study
Physical dimensions exceeding the limits of any equipment used
Stage III or greater congestive heart failure
Symptomatic peripheral vascular disease
Stroke
Severe hypertension (>170/100 mmHg)
Anemia (Hgb and Hct < normal reference range)
Receiving treatment for thyroid, pituitary, kidney or liver disease (except controlled thyroid hormone replacement)
History of diabetes (as told by doctor, or taking diabetic medications Fasting glucose value diagnostic for diabetes 2-h oral glucose tolerance test diagnostic for diabetes
Rheumatoid arthritis
History of wrist, hip or leg fracture after the age of 45
History of kidney stones
Medications that the investigator judges will make interpretation of the results difficult or increase the risk of participation (e.g. anticoagulants)
Any disease or condition that the investigator judges will affect bone metabolism or make interpretation of the results difficult or increase the risk of participation (e.g. anemia, cardiac decompensation, intolerance to pioglitazone, lidocaine, or other agents used)
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
HbA1c maximum 10 % by central laboratory analysis
Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination

Exclusion Criteria:

Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
Cardiovascular disease (CVD) defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to Visit 1
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
Known or suspected hypersensitivity to trial products or related products
Intervention: Nintedanib
Trial phase: Phase 2
ATC code: L01EX09
SMILES: COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: BIBF 1120 50 mg oral administration twice a day for cohort 1
Eligibility criteria:
Inclusion criteria:

Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
Forced vital capacity (FVC) 50-90%
Diffusing capacity for carbon monoxide (DLCO) 30-79%
For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria:

Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal range (ULN) at screening.
Bilirubin > 1.5 x ULN at screening.
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.
Continuous oxygen supplementation.
Active infection at screening or randomisation.

Being treated with any of the following concomitant medications.

Oral corticosteroid medication at unstable dose
ketoconazole or atazanavir
Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening
Intervention: Nintedanib
Trial phase: Phase 2
ATC code: L01EX09
SMILES: COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: BIBF 1120 100 mg oral administration twice a day for cohort 2
Eligibility criteria:
Inclusion criteria:

Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
Forced vital capacity (FVC) 50-90%
Diffusing capacity for carbon monoxide (DLCO) 30-79%
For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria:

Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal range (ULN) at screening.
Bilirubin > 1.5 x ULN at screening.
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.
Continuous oxygen supplementation.
Active infection at screening or randomisation.

Being treated with any of the following concomitant medications.

Oral corticosteroid medication at unstable dose
ketoconazole or atazanavir
Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening
Intervention: Nintedanib
Trial phase: Phase 2
ATC code: L01EX09
SMILES: COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: BIBF 1120 150 mg oral administration twice a day for cohort 3
Eligibility criteria:
Inclusion criteria:

Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
Forced vital capacity (FVC) 50-90%
Diffusing capacity for carbon monoxide (DLCO) 30-79%
For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria:

Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal range (ULN) at screening.
Bilirubin > 1.5 x ULN at screening.
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.
Continuous oxygen supplementation.
Active infection at screening or randomisation.

Being treated with any of the following concomitant medications.

Oral corticosteroid medication at unstable dose
ketoconazole or atazanavir
Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening
Intervention: DABIGATRAN ETEXILATE
Trial phase: Phase 2
ATC code: B01AE07
SMILES: CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Eligibility criteria:
Inclusion criteria Inclusion criteria

Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

Hypertension
Diabetes mellitus
Left-side heart failure
A previous ischemic stroke or transient ischemic attack
Age 75 years or older
A history of coronary artery diseases

Exclusion criteria Exclusion criteria

Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
Patients with atrial myxoma or left ventricular thrombosis
Patients with contraindication to anticoagulant therapies
Patients scheduled for major surgery or invasive procedure
Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
Patients with uncontrolled hypertension
Intervention: DABIGATRAN ETEXILATE
Trial phase: Phase 2
ATC code: B01AE07
SMILES: CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Eligibility criteria:
Inclusion criteria Inclusion criteria

Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

Hypertension
Diabetes mellitus
Left-side heart failure
A previous ischemic stroke or transient ischemic attack
Age 75 years or older
A history of coronary artery diseases

Exclusion criteria Exclusion criteria

Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
Patients with atrial myxoma or left ventricular thrombosis
Patients with contraindication to anticoagulant therapies
Patients scheduled for major surgery or invasive procedure
Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
Patients with uncontrolled hypertension
Intervention: Warfarin
Trial phase: Phase 2
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Dose-adjusted warfarin based on target INR values
Eligibility criteria:
Inclusion criteria Inclusion criteria

Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

Hypertension
Diabetes mellitus
Left-side heart failure
A previous ischemic stroke or transient ischemic attack
Age 75 years or older
A history of coronary artery diseases

Exclusion criteria Exclusion criteria

Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
Patients with atrial myxoma or left ventricular thrombosis
Patients with contraindication to anticoagulant therapies
Patients scheduled for major surgery or invasive procedure
Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
Patients with uncontrolled hypertension
Intervention: Humulin N
Trial phase: Phase 3
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
Eligibility criteria:
Major Inclusion Criteria:

No known history of diabetes
Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL
Non-critically ill and admitted to acute care medical services
Have a body mass index greater than or equal to 18.5 kg/m^2 and less than or equal to 45 kilograms per square meter (kg/m^2)

Major Exclusion Criteria:

Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization
Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL
Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry
Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period
Expected hospitalization less than 24 hours post-randomization
Intervention: EXENATIDE
Trial phase: Not Applicable
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)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](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.

Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Exclusion Criteria:

Patients with unstable cardiac, neurological or psychiatric disease
Women who are pregnant or report trying to get pregnant will be excluded.
Patients treated for obstructive sleep apnea (OSA) will be excluded.
Patients with established OSA will be included only if they have declined treatment of OSA.
Patients with morbid obesity (BMI ≥ 40 gk/m2)
Patients on insulin
Patients already taking an incretin-based drug will not be included
Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
Patients taking an insulin secretagogue will be excluded.
Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
Intervention: HYDROCORTISONE PROBUTATE
Trial phase: Phase 4
ATC code: D07AB11
SMILES: [H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
Good health with the exception of psoriasis or atopic dermatitis

Exclusion Criteria:

Any disease affecting the HPA-axis
Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
Intervention: Pasireotide
Trial phase: Phase 3
ATC code: H01CB05
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Pasireotide LAR 40 mg
Eligibility criteria:
Inclusion Criteria:

Patients with written informed consent prior to any study related activity
Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension

Exclusion Criteria:

Patients who had received pasireotide (SOM 230) prior to enrolment
Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy