linjc16/ctgov huggingface dataset:
Biologic Assessment of Satiety

Study Overview
=================
Brief Summary
-----------------
Subjective measures of satiety are correlated with biologic mechanisms of appetite control.

Official Title
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Biologic Assessment of Satiety

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical history (interview) demonstrating good health non-smoking not taking steroid-based medications not planning to or currently attempting to gain or lose weight being willing to consent to study conditions healthy adults ages 25-45 years body mass index between 18-30 kg/m2. University of North Dakota students may participate but student status is not required. Exclusion Criteria: diagnosed eating disorders current or planned pregnancy lactation unmanaged hypertension (systolic >160 mmHg or diastolic > 100mmHg) and/or other cardiovascular, pulmonary, skeletal and metabolic diseases taking medications known to affect appetite, body composition, weight, or food intake

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of subjective and objective satiety responses | Comparison of subjective responses and gut hormone responses of satiety | measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of subjective and objective measures of satiety | Repeated assessment (3 times) of subjective and objective responses to food intake | measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, satiety, body weight management
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

Official Title
-----------------
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Biological: Liberal
* Other: Restrictive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis with septic shock. Age >18 years Exclusion Criteria: Previous severe adverse reaction with blood products, Disseminated intravascular coagulopathy HCC Pregnancy Malignancy Active gastrointestinal bleeding Intracranial bleeding Chronic Kidney disease with Maintenance Hemodialysis Pulmonary Edema Congestive Heart Failure Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal<br>2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days | Biological: Liberal<br>* 2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days<br>|
| Active Comparator: Restrictive<br>To maintain the target Hemoglobin of 7 to 8 gm/dL. | Other: Restrictive<br>* To maintain the target Hemoglobin of 7 to 8 gm/dL.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in both groups |  | 28 dyas | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in vasopressors in both groups | Improvement is defined as tapering the dose of vasopressors | 28 days | 
| Incidence of complications in both groups |  | 28 days | 
| Length of ICU (Intensive Care Unit) stay |  | 28 days | 
| Requirement of mechanical ventilation in both groups |  | 28 days |
Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study

Study Overview
=================
Brief Summary
-----------------
The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg   15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis.

Official Title
-----------------
Post Marketing Surveillance to Assess the Safety and Efficacy of Mobic® (Meloxicam) Intramuscular Injection (7.5mg   15mg, q.d.) up to 3 Days (in Case of Need for Prolonged Treatment, Switch to Mobic® Capsule Therapy Was Possible) in Korean Patients With Osteoarthritis and Rheumatoid Arthritis (KFDA Regulatory Requirement PMS)

Conditions
-----------------
Osteoarthritis, Arthritis, Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: diagnosed as osteoarthritis and rheumatoid arthritis EXCLUSION CRITERIA: Known hypersensitivity to meloxicam Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs Active peptic ulceration Severe hepatic failure. Non-dialysed severe renal insufficiency Children and adolescents aged 15 years or less Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment by the treating physician |  | up to 3 day | 
| Combined efficacy, safety and tolerability assessment by the treating physician |  | up tp 3 day | 
| Incidence of adverse events |  | up tp 3 day |
Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

Study Overview
=================
Brief Summary
-----------------
All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer (PABC), which is too often diagnosed late Ultrasound is the first line breast imaging technique during pregnancy and lactation as Development of alveoli during pregnancy might not occur symmetrically, and these can be felt as focal nodularities, or even feel similar to masses, any suspicion of a mass should be assessed with US . If US illustrates glandular tissue and this correlates with the examiner presumption, no further work-up needs to be done. However, if presence of a mass is highly assumed, further follow-up by mammography, MRI and biopsy, when necessary, must be performed

Official Title
-----------------
Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

Conditions
-----------------
Preganat and Lactating Faemls

Intervention / Treatment
-----------------
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic Exclusion Criteria: Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lacating femals<br>screening of breast lesions in lactating female | Device: ultrasound<br>* screening of breast lesions by ultrasonography<br>|
| pregnant<br>screening of breast lesions in pregnant female | Device: ultrasound<br>* screening of breast lesions by ultrasonography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of breast lesions in pregnant and lactating females' | percent of breast lesions in pregnant and lactating females' | 12 month |
Early Immunosuppressants in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

Official Title
-----------------
Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: early immunosuppressants (azathioprine, methotrexate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 yr old diagnosis of Crohn's disease intestinal lesions demonstrated during the last 6 months disease duration < 6 months patients at high risk of disabling disease (having 2 criteria out of the 3 following: age < 40, perinanal disease, steroid for the first flare) Exclusion Criteria: prior prescription of immunosuppressants severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease) intestinal resection active infectious disease including HIV hepatic failure renal failure pregnancy high probability of poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control = conventional treatment<br>conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease | |
| Experimental: Immunossuppresive treatment<br>Switch to different immunosuppresive treatment in case of relapse. | Drug: early immunosuppressants (azathioprine, methotrexate)<br>* azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated<br>* Other names: Azathioprine = brand name = Imurel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of 3-months periods with remission |  | 3 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-yr cumulative steroid dose |  | 3 years | 
| quality of life questionnaire |  | 3 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn, immunosuppressants, natural history, steroids
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

Study Overview
=================
Brief Summary
-----------------
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.

Official Title
-----------------
An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for those with hepatic impairment: Physical signs consistent with a clinical diagnosis of liver cirrhosis Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment Otherwise considered healthy Inclusion criteria for healthy volunteers: • In good health. Exclusion criteria for those with hepatic impairment: Clinically significant abnormal findings other than hepatic impairment Clinical evidence of severe ascites History of surgical portosystemic shunt Any evidence of progressive liver disease within the last 4 weeks Exclusion criteria for healthy controls: Clinical evidence of liver disease or liver injury A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result Use of any prescription medication within 1 month prior to dosing Other protocol defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impaired<br> | Drug: Deferasirox<br>* one dose of 20 mg/kg/day<br>* Other names: ICL670;|
| Experimental: Moderate hepatic impaired<br> | Drug: Deferasirox<br>* one dose of 20 mg/kg/day<br>* Other names: ICL670;|
| Experimental: Severe hepatic impaired<br> | Drug: Deferasirox<br>* one dose of 20 mg/kg/day<br>* Other names: ICL670;|
| Experimental: Healthy volunteers<br>Controlled group | Drug: Deferasirox<br>* one dose of 20 mg/kg/day<br>* Other names: ICL670;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of deferasirox and its metabolites |  | at FPFV and at LPLV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of deferasirox assessed by adverse events |  | at FPFV and at LPLV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic impairment, adults, deferasirox
Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Study Overview
=================
Brief Summary
-----------------
Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .

Detailed Description
-----------------
All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV . Inclusion Criteria: Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV. All patients will be received steroids , MMF and Angiotensin Converting Enzyme. Exclusion Criteria: Patients diagnosed with lupus nephritis class I,II,V and VI. Patients received Cyclophosphamide in stead of MMF.

Official Title
-----------------
Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis

Conditions
-----------------
Proliferative Nephritis, Chloroquine Retinopathy

Intervention / Treatment
-----------------
* Drug: Chloroquine
* Drug: Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV. All patients will be received steroids , MMF and Angiotensin Converting Enzyme. Exclusion Criteria: Patients diagnosed with lupus nephritis class I,II,V and VI. Patients received Cyclophosphamide in stead of MMF.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus nephritis III or IV/chloroquine<br>receiving chloroquine with daily dose 5 mg/kg | Drug: Chloroquine<br>* group1 received chloroquine .<br>* Other names: alexoquine;|
| Lupus nephritis III or IV/hydroxychloroquine<br>receiving hydroxycholorquine with daily dose 5 mg/kg | Drug: Hydroxychloroquine<br>* Group 2 received hydroxychloroquine<br>* Other names: hydroquine;|
| Systemic lupus erythematosus<br>not received hydroxychloroquine nor chloroquine . | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundus examination as screening test | Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage. | 12 months |
Prediction Model of Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. Previous multi- center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. Several prediction models of vitamin D deficiency had been built for the general population but not patients admitted in intensive care units. This multi-center retrospective study aims to develop and validate a score-based prediction model for severe vitamin D deficiency in critically ill patients. Investigators will review the data of previous multicenter, prospective, observational study. For temporal validation, the data will be divided into a derivation cohort (first 80% of the data set based on chronology) and a validation cohort (the remaining data set). The development and validation of the models will be carried out following the recommendations established in the Transparency Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) initiative.

Official Title
-----------------
Prediction Model of Vitamin D Deficiency in Critically Ill Patients

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Admitted to intensive care units


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to intensive care units Exclusion Criteria: aged < 20 years admitted to intensive care unit longer than 28 days body max index < 18 kg/m2 receive vitamin D supplement > 3000 IU/day previously admitted to intensive care unit within 3 months have parathyroid disease, rickets, or severe liver cirrhosis [Child C]

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>Patients admitted to intensive care units | Other: Admitted to intensive care units<br>* Admitted to intensive care units<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the score-based prediction model | Area under the receiver operating characteristic (AUROC) and area under precision recall curve (AUPRC) of the prediction models for severe vitamin D deficiency | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical care, vitamin D