linjc16/ctgov huggingface dataset:
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.

Official Title
-----------------
ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis

Conditions
-----------------
Anemia, Hemodialysis, Renal Impairment

Intervention / Treatment
-----------------
* Drug: roxadustat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic renal failure patients receiving hemodialysis thrice weekly Body weight: >=40.0 and <80.0 kg Mean hemoglobin level >=10.0 and =<12.0 g/dL Exclusion Criteria: Patients with severe inflammation or infection Patients who have a medical history of gastrointestinal surgery or enterectomy Patients who have uncontrolled hypertension Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases Patients who have a medical history of severe cardiac or cerebrovascular diseases Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks Patients with a medical history of serious drug allergies Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 group<br>Participants received a single oral dose of ASP1517 on Days 1 and 8 | Drug: roxadustat<br>* oral<br>* Other names: ASP1517;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASP1517 concentrations in plasma |  | For 96 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASP1517 concentrations in dialysate |  | For 6 hours after dosing | 
| Plasma EPO level |  | Pre dosing and for 24 hours after dosing | 
| Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests |  | For 96 hours after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
The Effect of Feldenkrais Lessons on Walking and Balance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of a series of Feldenkrais movement lessons on mobility and balance, particularly for older adults. The investigators hypothesise that mobility and balance will improve following the classes.

Detailed Description
-----------------
The Feldenkrais Method is an educational process which involves exploration of novel movement sequences that lead to expansion of the movement repertoire. This Method has been used with the aim of improving balance and mobility in several studies, and has been compared to the benefits of Tai Chi for improving balance in older adults. The current study investigates the effects of a 10 week series of Feldenkrais movement classes on gait parameters as measured on an instrumented gait mat, a balance test of stepping and turning (the Four Square Step Test) and a questionnaire about balance confidence (the Activites Specific Balance Confidence scale.

Official Title
-----------------
The Effect of Feldenkrais Lessons on Walking and Balance

Conditions
-----------------
Accidental Falls, Exercise

Intervention / Treatment
-----------------
* Behavioral: Feldenkrais Movement class


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: community dwelling older adults (aged over 65) able to independently ambulate indoors and outdoors Exclusion Criteria: currently undergoing physiotherapy treatment unable to comprehend written english unable to give informed consent walking with a walking frame indoors

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Feldenkrais Movement class|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance Confidence (as measured by ABC scale) |  |  | 
| Tempo-spatial parameters of gait |  |  | 
| Time to complete Four Square Step Test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feldenkrais Method, movement class, balance, Four square step test, Activities Specific Balance Confidence Scale, systems theory
Clinical Benefit of CBT for Insomnia in Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate using an RCT the potential benefits of CBT for insomnia in the community

Official Title
-----------------
Clinical and Health Economic Benefit of Non-Pharmacological Treatment of Chronic Insomnia in Primary Care

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behaviour Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult years (18+), living at home Meets clinical/RDC criteria for chronic insomnia Exclusion Criteria: Deteriorating health Untreated major mental disorder

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behaviour Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of Amino Acid Supplement During Acute Inflammation.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids. E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response. The study is an interventional randomized placebo study including 8 healthy male subjects. Each subject participates 3 times (different days) and are given one of following interventions: Placebo (NaCl) Endotoxin, US standard reference E.Coli + Placebo (NaCl) Endotoxin, US standard reference E.Coli + Amino acids (intravenously) It is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.

Official Title
-----------------
Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.

Conditions
-----------------
Febrile Illness Acute, Inflammation, Metabolic Diseases

Intervention / Treatment
-----------------
* Biological: E. coli endotoxin, US standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male gender 20<BMI<30 Age > 25 years old Written consent before starting the study Exclusion Criteria: Allergy for soya products ore egg Diabetes Epilepsy Infection Immune defects Heart disease Dysregulated hypertension Participating in other trials using radioactive tracers or x-rays the last year.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Saline<br>Only saline is given. | |
| Placebo Comparator: + Saline<br>Endotoxin is given + Placebo (Saline) | Biological: E. coli endotoxin, US standard<br> <br> |
| Active Comparator: + amino acids<br>Endotoxin is given + amino acids (intravenously) | Biological: E. coli endotoxin, US standard<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein catabolism during acute illness | Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples. | After 6 hours intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The local effects on muscle and fat tissue | A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues. | At 2 hours and 4,5 hours | 
| Other systemic metabolic effects during acute illness | Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid. | 6 hours |
Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Study Overview
=================
Brief Summary
-----------------
Observational medical record review of newly diagnosed CML-CP participants in China

Official Title
-----------------
Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study

Conditions
-----------------
Chronic Myeloid Leukemia, Philadelphia Chromosome, Chronic Myeloid Leukemia in Chronic Phase

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016 18 years or older at time of diagnosis Exclusion Criteria: Participants once enrolled in any interventional clinical trial for CML Participants whose records are not available Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Participants newly diagnosed with CML-CP<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants receiving each first-line treatment option |  | 2 years | 
| Number of participants with complete cytogenetic response | Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM) | 2 years | 
| Number of participants with major molecular response (MMR) | Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA | 2 years | 
| Number of participants of each initial dose schema |  | 2 years | 
| Starting dose of each first-line agent |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of demographic characteristics | Including age, sex, height, weight | 2 years | 
| Distribution of clinical characteristics | Including health insurance and comorbid conditions | 2 years |
NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis

Study Overview
=================
Brief Summary
-----------------
To improve the treatment outcome in patients with tuberculosis and integrate the pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis medication-induced hepatitis.

Official Title
-----------------
The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis

Conditions
-----------------
Hepatotoxicity

Intervention / Treatment
-----------------
* Drug: isoniazid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years. Take INH for at least a week. abnormal liver function (ALT (alanine, transaminase) increased by more than three times the upper limit of normal, or ALT higher than twice the upper limit of normal and total bilirubin higher than 2.0 mg / dL Exclusion Criteria: 1.Taking INH before liver function abnormalities. 2.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isoniazid rechalleng<br>When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly. | Drug: isoniazid<br>* dose adjustment according to the pharmacogenomic results<br>* Other names: Duracin, Rifina;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful re-use of isoniazid for TB treatment | In this study, we would like to test the hypothesis of NAT2 genotyping helping in isoniazid rechallenge after patients experienced adverse effects of anti-TB treatment. Therefore, to observe the patients can re-use isoniazid successfully is an important outcome measure in this study. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacogenetics, anti-tuberculosis drug, genetic polymorphism, isoniazid
Computer-Assisted, Game-Based Cognitive Training on Attention

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the effect of 8 weeks of cognitive training on attention function in healthy young people.

Official Title
-----------------
The Effect of Computer-Assisted, Game-Based Cognitive Training on Attention: A Randomized Controlled Study

Conditions
-----------------
Young Adults, Attention

Intervention / Treatment
-----------------
* Other: Computer assited, game-based cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those between the ages of 21-24, No communication problem, Not continuing any exercise program for the last 1 year, Having a smart phone, tablet or computer required to participate in the training program, Individuals who volunteered to participate in the study. Exclusion Criteria: Having vision and hearing problems, Individuals who continued the physical exercise program and/or had hobbies such as puzzles and jigsaw puzzles that could affect the cognitive level.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 24 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive training group<br>The training group received 20 minutes of cognitive training every day for 8 weeks | Other: Computer assited, game-based cognitive training<br>* After recording the demographic information of the participants, the Stroop Test was applied to evaluate attention. After the stages of the test were explained to the participants in detail, they were shown once in practice. The training group received 20 minutes of cognitive training every day for 8 weeks. No training was applied to the control group. Groups were evaluated at baseline and after 8 weeks.<br>|
| No Intervention: Control group<br>No training was applied to the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop test | The Stroop Test is a test that evaluates frontal lobe functions and cognitive processes such as attention and information processing. The Stroop Test TBAG Form consists of four white cards measuring 14.0 x 21.5 cm. The performance of the participants was scored according to three separate criteria for each section: These criteria are: the time taken until the last item of the section is answered with the start command, the number of errors, the number of corrected responses. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive-training
A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the improved responsiveness to treatment achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be explained by CsA's inhibitory action on the circulating suPAR expression.

Official Title
-----------------
A Prospective Controlled Follow-up of Serum Soluble Urokinase Receptor in the Cyclosporine A-treated Patients With Steroid-dependent and Steroid-resistant Focal Segmental Glomerulosclerosis

Conditions
-----------------
FSGS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at entry is between 14 and 70 years biopsy-proven primary FSGS proteinuria >=3 g/day without corticosteroids or CsA treatment before entry Exclusion Criteria: Chronic Inflammatory Diseases malignant tumor diabetes mellitus contraindications for the treatment of corticosteroids or CsA treatment untolerate to or unwilling to accept corticosteroids or CsA treatment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| steroid-sensitive FSGS<br> | |
| steroid-dependent and resistant FSGS<br> | |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum suPAR level when proteinuria reduction >=50% or complete remission | serum suPAR level when proteinuria reduction of >=50% or complete remission occurs within <=6 months of steroid alone or CsA plus steroid treatment | 6 months after steriod alone or CsA plus steriod treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum suPAR level after 6 months of steroid or CsA treatment without remission | serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission | 6 months after steroid alone or CsA plus steroid treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FSGS, suPAR
The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM), and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children with cerebral palsy (CP). METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this study. Each child carried out the SEBT and was assessed by two examiners. To determine intra-rater reliability, the investigators calculated the intra-class correlation coefficient (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the inter-rater reliability.

Conditions
-----------------
Search MeSH

Intervention / Treatment
-----------------
* Other: The star excursion balance test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were aged between 4 and 12 years, had a status above level II on the Gross Motor Function Classification System (GMFCS), were able to understand instructions from the rater, and Exclusion Criteria: had history of fracture or sprain of the lower limbs over the previous 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The star excursion balance test<br>The star excursion balance test: simple test for dynamic balance | Other: The star excursion balance test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The star excursion balance test |  | 6 months |