linjc16/ctgov huggingface dataset:
Liposomal Amikacin Inhalation in M.Abscessus Patients

Study Overview
=================
Brief Summary
-----------------
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results. The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes

Official Title
-----------------
NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients

Conditions
-----------------
M.Abscessus Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: ATS diagnostic criteria for M.abscessus pulmonary disease > 12 years Patients with CF/COPD or other underlying disease LAI use for more than 3 weeks Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: • Extra-pulmonary or disseminated disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| culture conversion | Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical cure | Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used | 1 day |
Mild Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described. Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment. The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.

Official Title
-----------------
Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: open carpal tunnel release
* Other: Night-cast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study Exclusion Criteria: rheumatoid arthritis diabetes mellitus hypothyreosis pregnancy wrist trauma or previous surgery splinting or corticosteroid injection on the affected side

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Operative<br> | Procedure: open carpal tunnel release<br>* surgery to release the carpal tunnel<br>|
| Active Comparator: Conservative<br> | Other: Night-cast<br>* individual night time splinting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Severity Score |  | 1 year | 
| Pain Visual Analogue Scale (VAS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in electroneuromyography |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal tunnel syndrome, CTS, medianus impingement
Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient

Study Overview
=================
Brief Summary
-----------------
This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol%

Detailed Description
-----------------
Twenty-two subjects were given informed consent before study enrolled. Anesthesia was induced by 8% sevoflurane with 6 L flow of 100% oxygen. IV cannulation was attempted at 2 min in the first child in each group. The time for cannulation in the next child was stepped up or down by 15 s depending on positive or negative response, respectively, in the previous child. Children were recruited till a minimum of six pairs of failure-success sequence which was obtained in the group. The mean of midpoints of the failure-success sequence was calculated to obtain the time for cannulation in 50% of the group.

Official Title
-----------------
Determination Effective Dose 95 (ED95) of Intravenous Cannulation With the Induction of Sevoflurane 8 Vol% in Patients Aged 1-3 Years Using Dixon up and Down Method

Conditions
-----------------
Movement After Intravenous Cannulation

Intervention / Treatment
-----------------
* Device: IV cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-3 year Physical state ASA I dan II Parents of patients who agreed to participate and sign informed consent. Exclusion criteria: Patients with difficult airway There's allergic reaction or drug's side effect after induction There's cardiorespiratory problem such as anaphylactic shock, aritmia, severe hypotension, desaturation before-on-or after induction

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: time for cannulation<br>intravenous cannulation after sevoflurane induction | Device: IV cannula<br>* We measure the time duration needed for IV cannulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED50 in intravenous cannulation after sevoflurane induction | using Dixon Up and Down Method | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, general anesthesia, induction of anesthesia, sevoflurane, venous cannulation
The Real World Study of Autism Spectrum Disorder in China

Study Overview
=================
Brief Summary
-----------------
The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.

Detailed Description
-----------------
Children with autism spectrum disorder registered in Xinhua Hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (MRI), functional near - infrared spectroscopy(f-NIRS), electroencephalography and eye movement. The investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.

Official Title
-----------------
The Real World Study of Children With Autism Spectrum Disorder in China

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with autism spectrum disorder registered in Xinhua hospital written informed consent provided Exclusion Criteria: NA

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour assessment | The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc. | The baseline and 3 months |
Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity

Study Overview
=================
Brief Summary
-----------------
Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.

Official Title
-----------------
Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity

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

Intervention / Treatment
-----------------
* Dietary Supplement: Molecular hydrogen
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 55 years body mass index > 25 kg/m2 Exclusion Criteria: no history of H2 supplementation within the 4 weeks before study commenced no major chronic diseases, as evaluated by pre-participation health screening and clinical chemistry

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular hydrogen<br>Molecular hydrogen, tablet, 2 g/day, 4 weeks | Dietary Supplement: Molecular hydrogen<br> <br> |
| Placebo Comparator: Placebo<br>Cellulose, tablet, 2 g/day, 4 weeks | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage change | Baseline vs. four weeks | Baseline vs. four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin change in IU/mL | Baseline vs. four weeks | Baseline vs. four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Molecular hydrogen, Insulin
Exploring Medical Decisions Using Functional MRI

Study Overview
=================
Brief Summary
-----------------
Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.

Official Title
-----------------
Medical Decision-making Under Budgetary Constraint: an fMRI Study

Conditions
-----------------
F-MRI Brain Imaging Data

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital physicians working in the CHU of Montpellier Exclusion Criteria: Contra indication to f-MRI

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

| Intervention/Treatment |
| --- |
|Other: no intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation patterns measured by Functional magnetic resonance imaging |  | up to study completion, usually 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964) |  | up tu study completion, usually 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospital, medical decision-making, role conflict, f-MRI
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

Study Overview
=================
Brief Summary
-----------------
To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Detailed Description
-----------------
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Official Title
-----------------
Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

Conditions
-----------------
Mycobacterium Avium Complex Lung Disease

Intervention / Treatment
-----------------
* Drug: clarithromycin, rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus). Adults age 18 and older Pretreatment isolate of M. avium complex available for MIC determination Exclusion Criteria: History of allergy to study drugs If a mensruating female, not pregnant and on adequate birth control. Children less than 18 years of age HIV + or at high risk for HIV infection.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clarithromycin and rifabutin/rifampin<br>Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly. | Drug: clarithromycin, rifabutin<br>* Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.<br>* Other names: Biaxin, mycobutin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures | sputum conversion culture neg x3 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes | culture neg 1 yr on treatment | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAC
Surgical Stress After Laparoscopic Compared to Open Liver Resection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.

Official Title
-----------------
Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Procedure: laparoscopic liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 left hemihepatectomy(liver resection) left lateral sectionectomy(liver resection) Exclusion Criteria: Patients with diabetes mellitus drug abuse BMI >24 or <18

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic liver resection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative insulin resistance calculated by serum insulin and blood glucose | At baseline prior to surgery, and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured. Insulin resistance is assessed by the HOMAIR(homeostatic model assessment of insulin resistance) score which is calculated through the mathematic formula: HOMAIR= FI ×FG/22.5, where FI= fasting serum insulin(μU/mL), FG= fasting plasma glucose (mmol/L), and 22.5 is a constant. | within the first 72hrs after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation | At baseline before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, duplicated samples were drawn to analyze serum IL-1β, IFN-γ, IL-4 and IL-10. | within 5 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic liver resection, cytokine release
Protein Hydrolyzation and Glycemic Control

Study Overview
=================
Brief Summary
-----------------
The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.

Official Title
-----------------
The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Protein hydrolyzation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age between 40 and 70 years Oral blood glucose lowering medication BMI < 35 kg/m2 Exclusion Criteria: Exogenous insulin use Cardiac disease (any cardiac event in the last 5 years) Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio >2,5)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Protein hydrolyzation<br> <br> |
| Experimental: Intact protein<br> | Dietary Supplement: Protein hydrolyzation<br> <br> |
| Experimental: Protein hydrolysate<br> | Dietary Supplement: Protein hydrolyzation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose and insulin homeostasis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acid profiles |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, protein, protein hydrolysate
Predictive Value of a mRNA Signature and Liquid Biopsy in Diffuse Large B Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the predictive value of a mRNA signature and liquid biopsy in patients with Diffuse Large B cell lymphoma.

Official Title
-----------------
Predictive Value of a mRNA Signature and Liquid Biopsy in Diffuse Large B Cell Lymphoma

Conditions
-----------------
Diffuse Large B Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved Diffuse Large B cell Lymphoma newly diagnosed between 2000-01 and 2015-12 Exclusion Criteria: patients with biopsy samples unavailable

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 |
| --- | --- |
| tested group<br> | |
| controlled group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5-years |