linjc16/ctgov huggingface dataset:
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Study Overview
=================
Brief Summary
-----------------
We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

Detailed Description
-----------------
Patients with pulmonary MAC with a lower BMI than healthy individuals also have a significantly poorer prognosis than those of normal weight. Emaciation in such patients is thought to be caused by destruction of lung structure from disease progression and an increased resting metabolic rate caused by the increased load from breathing; however, causes of emaciation and details of energy metabolism in these patients have not been studied. Elucidating details of energy metabolism and causes of emaciation in patients with pulmonary MAC could provide the basis for improvement in nutritional status and activities of daily living through early nutrition therapy and rehabilitation. We propose to clarify the following: Energy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie intake and consumption, and hormonal secretions. Relation between energy metabolism and degree of pulmonary MAC progression.

Official Title
-----------------
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Conditions
-----------------
Emaciation, Pulmonary MAC, Energy Metabolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with pulmonary MAC. Exclusion Criteria: Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Relation between energy balance and pulmonary MAC severity |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between inflammation (CRP et.) and pulmonary MAC severity |  | Three years | 
| Relation between bone mineral density and pulmonary MAC severity |  | Three years | 
| Relation between hormone secretion and pulmonary MAC severity |  | Three years | 
| Relation between pulmonary function and pulmonary MAC severity |  | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary MAC, energy metabolism
Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS). II. Determine the side-effects and benefits associated with DAP.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to receive 3,4-diaminopyridine (DAP) or placebo orally 3 times daily for 5 days, after which treatment is discontinued and patients are observed for at least 24 hours. At the end of the blinded study, patients may then elect to take open label DAP orally 3 times daily for 6 months; those who do so are monitored for clinical effects and side effects for at least 6 months.

Conditions
-----------------
Lambert-Eaton Myasthenic Syndrome

Intervention / Treatment
-----------------
* Drug: 3,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Lambert-Eaton myasthenic syndrome (LEMS) based on weakness that predominates in proximal limb muscles and electromyography (EMG) findings of small amplitude muscle responses to nerve stimulation, which decrease further during nerve stimulation at 5 Hz and which increase at least 2-fold after maximum voluntary contraction of the muscle for 10-20 seconds Quantified Myasthenia Gravis (QMG) clinical score at least 5 --Prior/Concurrent Therapy-- Chemotherapy: No concurrent chemotherapy Endocrine therapy: Patients receiving immunosuppressants must be on the same dose of medication for at least 3 months prior to study entry Radiotherapy: No concurrent radiotherapy Surgery: No concurrent surgery Other: Patients receiving cholinesterase inhibitors must discontinue the medication at study entry if possible, or else be on the same dose of medication for at least 1 month prior to study entry --Patient Characteristics-- Hematopoietic: No significant hematologic disease Hepatic: No significant hepatic disease Renal: No significant renal disease Cardiovascular: No cardiac arrhythmia or significant cardiac disease Neurologic: No seizure disorder Other: Not pregnant Negative pregnancy test required of fertile women Effective contraception required of fertile women

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3,4-diaminopyridine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lambert-Eaton myasthenic syndrome, neurologic and psychiatric disorders, rare disease
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Detailed Description
-----------------
Probiotics have been proved to shorten duration of diarrhea in children; whether they are cost-effective is less clear. We'd like to validate the use of Infloran, a proprietary probiotic sold in Thailand, in terms of its cost-effectiveness compared to standard diarrhea care in our hospital setting.

Official Title
-----------------
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

Conditions
-----------------
Acute Diarrhea

Intervention / Treatment
-----------------
* Drug: Probiotic - Infloran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 3 months to 6 years of age Hospitalized due to acute diarrhea Exclusion Criteria: History of probiotic treatment in this episode of illness History of use of other anti-diarrheal medications Chronic gastrointestinal disease(s) Severe dehydration Severe systemic disease(s)

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The group of patients treated with placebo. | Drug: Probiotic - Infloran<br>* Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid<br>* Other names: B. bifidum;|
| Experimental: Infloran<br>The group of patients treated with Infloran. | Drug: Probiotic - Infloran<br>* Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid<br>* Other names: B. bifidum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monetary cost of hospitalization in Thai Baht |  | from admission to discharge date, approximately 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of hospitalization |  | from admission to discharge date, approximately 1-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diarrhea, probiotic, cost-effectiveness, children, Sum of the monetary cost of the hospitalization
Clinical Epidemiology Cohort Study for Patient Living With HIV

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational cohort study for the patient living with HIV aiming to understand more in disease progress, resistant mutation, comorbidity, and common coinfection.

Official Title
-----------------
Clinical Epidemiology Cohort Study for Patient Living With HIV

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Other: intervention name is not applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient living with HIV receiving follow-up in Kaohsiung VGH Exclusion Criteria: not applicable

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

| Intervention/Treatment |
| --- |
|Other: intervention name is not applicable|Another intervention is not applicable either, due to the observational study design|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratio of cohort epidemiology characteristics in treatment failure, renal failure and hepatitis D coinfection |  | on average of 3 year |
Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

Study Overview
=================
Brief Summary
-----------------
Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Detailed Description
-----------------
An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Official Title
-----------------
A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Drug: IDP-120 Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female between the ages of 9 and <17 (16 years 11 months) Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment. Subject with facial acne inflammatory lesion count no less than 20 but no more than 40. Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100. Key Exclusion Criteria: Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis. Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive. Subjects with a facial beard or mustache that could interfere with the study assessments Subjects with more than 2 facial nodules.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-120 Gel<br>Gel | Drug: IDP-120 Gel<br>* Gel<br>* Other names: Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluators Global Severity Score At Day 15 | Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe). | 15 Days |
MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to combine and correlate data from morphological and functional MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.

Detailed Description
-----------------
A prospective study including 180 consecutive patients with PCa referred to Oslo University Hospital, Radiumhospitalet, for surgical treatment. In vivo functional MRI examination will be performed within a few days prior to robot-assisted radical prostatectomy (RALP). For a subgroup of patients FACBC PET will also be acquired prior to prostatectomy. A subgroup of intermediate and high-risk patients (D'Amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (Hypoxyprobe™-1)*. During surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. High-risk patients will undergo intraoperative lymph node dissection. Tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. Prostate specimen and regional lymph nodes will be histopathologically examined for T- and N-classification, Gleason grade, presence of micrometastasis and areas of hypoxia. Histological and molecular findings will be correlated to MRI and PET findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death). *From 2013 oral administration is used.

Official Title
-----------------
MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Conditions
-----------------
Prostatic Neoplasms, Genital Neoplasms, Male, Prostatic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suitable for surgery with confirmed prostate cancer, Gleason grade ≥ 3 Patient has received no prior treatment for prostate cancer. Patient has adequate renal function: Estimated creatinine clearance ≥ 60 ml/minute. Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee. Exclusion Criteria: Patient with contraindication to MR or MR contrast media according to clinical practice. Patients who want to withdraw for any reason during the study. Patients previously undergone pelvic surgery or radiation therapy
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Death |  | 2030 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Magnetic Resonance Imaging, Prostate cancer, FACBC PET, Hypoxia imaging
Regorafenib Post-marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Official Title
-----------------
Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients who are determined to start Regorafenib/ STIVARGA treatment Exclusion Criteria: Patients who have previously received Regorafenib/ STIVARGA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* Patients treated with Regorafenib under practical manner for colorectal cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib |  | Up to 6 months | 
| Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pateints with ADRs in subpopulations |  | Up to 6 months | 
| Number of patients with SAEs in supopulations |  | Up to 6 months | 
| Overall survival (OS) |  | Up to 12 months | 
| Overall survival in subpopulations |  | Up to 12 months | 
| Time to treatment failure (TTF) |  | Up to 12 months | 
| Time to Treatment failure in subpopulations |  | Up to 12 months | 
| Tumor response assessed by RECIST or physicians own evaluation | RECIST: Response Evaluation Criteria In Solid Tumors | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Neoplasms, Regorafenib
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.

Official Title
-----------------
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is being evaluated for the diagnosis of possible lung cancer or rule out lung cancer and is indicated for bronchoscopy. The patient is undergoing bronchoscopy ≥ 21 years of age Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy The patient is a current or former cigarette smoker (defined as having smoked >100 cigarettes in their lifetime. Exclusion Criteria: The Pulmonary physician does not recommend that bronchoscopy be performed The patient is unable to be consented into the study or unable to comply with requirements of the study The patient has previously been diagnosed with primary lung cancer Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Primary Lung Cancer |  | One year from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gene Expression, Lung Cancer, Smoking
Trial of Screening for ALOA-IgG AtheroAbzyme Test

Study Overview
=================
Brief Summary
-----------------
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.

Official Title
-----------------
Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients

Conditions
-----------------
Myocardial Ischemia, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: ALOA IgG-Elisa
* Device: ALOA IgG-AtheroAbzyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients High Risk patients or Asymptomatic myocardial Ischemic patients Acute Coronary Syndrome patients Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Healthy patients<br> | Device: ALOA IgG-Elisa<br>* measurement of IgG Level in blood<br>Device: ALOA IgG-AtheroAbzyme<br>* measurement of IgG in blood<br>|
| Active Comparator: Asymptomatic myocardial Ischemic patients<br> | Device: ALOA IgG-Elisa<br>* measurement of IgG Level in blood<br>Device: ALOA IgG-AtheroAbzyme<br>* measurement of IgG in blood<br>|
| Active Comparator: Acute Coronary Syndrome Patients<br> | Device: ALOA IgG-Elisa<br>* measurement of IgG Level in blood<br>Device: ALOA IgG-AtheroAbzyme<br>* measurement of IgG in blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Determination of the level of oxidised LDL by measuring the level of IgG in Blood