linjc16/ctgov huggingface dataset:
Mental Health Promotion Interventions Among Migrant Workers in China

Study Overview
=================
Brief Summary
-----------------
The goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in China.

Official Title
-----------------
Mental Health Promotion Interventions for Reducing Self-reported Depression and Improving Rates of Early Detection of Depression Among Migrant Workers in China, a Cluster Randomised Controlled Trial

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Other: mental health promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who worked in the factory agreed to take participant in this study and could understand the questionnaire. Exclusion Criteria: People who don't want to take participant in the study; People can not understand the questionnaire.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mental health promotion group<br> | Other: mental health promotion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing rate of self-reported depression in BDI |  | Change from baseline to one year after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing rate of early detection of depression |  | change from baseline to one year after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental health promotion, depression, migrant workers, China
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)

Study Overview
=================
Brief Summary
-----------------
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric, non randomized and with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.

Conditions
-----------------
Alternative Method of Apnea Test

Intervention / Treatment
-----------------
* Procedure: Apnea test - control
* Procedure: Apnea test - CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : from 18 to 70 years Neurological signs evoking cerebral ischemia Exclusion Criteria: Severe hypoxemia (PaO2/FiO2 < 200) with controlled ventilation (FiO2: 100%) Hypothermia < 36°C Obesity (BMI ≥ 40) with documented hypopnoea Intractable hypotension despite optimal filling and catecholamine doses > 1µg.Kg.min Patients with contraindication for organs harvesting. Documented chronic respiratory failure Progressive infectious acute respiratory disease Family opposition to subject's participation in the study

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard strategy<br>Apnea test according to recommendations | Procedure: Apnea test - control<br> <br> |
| Experimental: CPAP strategy<br>Apnea test with CPAP connection | Procedure: Apnea test - CPAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility to donor lung harvest |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of hypoxemia |  |  | 
| Arterial blood gas after th apnea test |  |  | 
| Rate of ventilatory disorder |  |  | 
| Rate of cardiocirculatory disorder |  |  | 
| Rate of apnea test interruption |  |  | 
| Number of lung transplantation realization |  |  |
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine

Study Overview
=================
Brief Summary
-----------------
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

Detailed Description
-----------------
cage: MC+® cage plate: atlantis® plate

Official Title
-----------------
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine

Conditions
-----------------
Cervical Vertebrae, Single, Degenerative Disease

Intervention / Treatment
-----------------
* Procedure: Cage fusion
* Procedure: Plate fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single level degenerative cervical spine disease aged 30 - 70 no improvement of symptom for 8 weeks of non-surgical treatment. degeneration in other levels without stenosis, accepted Exclusion Criteria: osteoporosis disease with poor bone quality Cancer Previous cervical spine surgery Multiple levels disease Ossification of posterior longitudinal ligament Kyphosis at the index level Developmental stenosis (diameter of C7 spinal canal < 10mm)

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Interventional Model Description: ACDF with plate and autologous bone
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cage<br>Cage filled with autologous bone | Procedure: Cage fusion<br>* Randomized selection of surgery type<br>* Other names: Use of stand-alone Cage filled with autologous bone;|
| Other: Plate<br>Plate augmentation after iliac bone graft | Procedure: Plate fusion<br>* Randomized selection of surgery type<br>* Other names: Use of Plate augmentation after autologous iliac bone graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | The rate of interbody fusion at 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmental angle | the segmental angle at the fused level | 2 years | 
| cervical lordosis | The cervical lordosis at 2 years | 2 years | 
| pain change | Visual analogue pain score | 2 years | 
| functional status change. | Neck disability index | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical vertebrae, single, degenerative disease, Fusion, Sagittal angle
Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

Study Overview
=================
Brief Summary
-----------------
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Detailed Description
-----------------
QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Official Title
-----------------
Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. Signed informed consent form from adult patient or parent/guardian of pediatric patient. Patient must have a valid mailing address within the United States to receive QOL surveys. Ability to speak and read English. Patients with access to a telephone.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| HSCT recipients<br>Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. Signed informed consent form from adult patient or parent/guardian of pediatric patient. Patient must have a valid mailing address within the United States to receive QOL surveys. Ability to speak and read English. Patients with access to a telephone. | |

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
-----------------
Hematopoietic stem cell transplantation, QOL
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

Official Title
-----------------
A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AMG 108
* Drug: AMG 108


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll. Exclusion Criteria: Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>350 | Drug: AMG 108<br>* 125 mg via SC (subcutaneous) injection every 4 weeks<br>|
| Experimental: 2<br>350 | Drug: AMG 108<br>* 250 mg via SC (subcutaneous) injection every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168 |  | 144 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether long-term use of AMG 108 improves function in subjects with RA |  | 144 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis
DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
Analysis of differential gene expression in patients with chronic rhinosinusitis without polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical outcomes.

Official Title
-----------------
DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

Conditions
-----------------
Chronic Rhinosinusitis w/o Nasal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Affected patients: Two or more of the following symptoms should be present for 12 weeks or more: anterior mucopurulent drainage, posterior mucopurulent drainage; nasal obstruction; and facial pain-pressure-fullness. Signs of nasal inflammation such as discolored mucus, edema of the middle meatus or ethmoid area should be documented by endoscopy. The symptoms of rhinosinusitis have failed to resolve or have recurred after a treatment course with antibiotics and nasal and/or oral steroids. The diagnosis of rhinosinusitis should be confirmed with a CT scan. Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium Patients were not previously diagnosed with reactive airway disease or aspirin sensitivity. Patients also must meet the standard criteria for endoscopic sinus surgery and scheduled to undergo their procedure at MMC. Unaffected Patients: Patients undergoing elective nasal surgery at MMC. Patients deny symptoms of allergic rhinitis such as nasal congestion, nasal discharge, itching, sneezing. Patients deny symptoms of chronic or acute rhinosinusitis such as nasal obstruction, facial pain-fullness-pressure, anosmia, anterior and/or posterior mucopurulent drainage. Nasal endoscopy showed no evidence of nasal inflammatory disease, such as erythema, edema, polyps, or discolored mucus. Patients do not have history of prior sinus surgeries and were not previously diagnosed with CRS. Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium. Patients were not diagnosed with reactive airway disease or aspirin sensitivity. The absence of evidence of inflammation, such as inflammatory infiltrate or epithelial dysplasia on histopathologic exam of nasal mucosa obtained during surgical procedure.

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 |
| --- | --- |
| 1<br>Chronic Rhinosinusitis w/o nasal polyps | |
| 2<br>No sinus disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Long Term Oxygen Therapy in Patients With Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia

Detailed Description
-----------------
long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients

Official Title
-----------------
Role of LTOT in Pateints With ILD

Conditions
-----------------
Long Term Oxygen Therapy, Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : patients with ILD and hypoxia with SO2<88 at room air and PO2 < or equal 7.3k.pa or < or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia age group 18 : 70 Exclusion Criteria : Causes of chronic respiratory failure other than ILD.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Dyspnea score improvement | dyspnea by Modified Medical Research Counsel | Baseline | 
| Quality of life improvement | Quality of life by st.George questionnaire | Baseline |
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

Study Overview
=================
Brief Summary
-----------------
Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.

Detailed Description
-----------------
3,4-diaminopyridine (3,4-DAP) decreases symptoms of weakness in patients with LEMS, and therefore can be used to decrease the amount of immune modulation therapy needed to provide an equivalent degree of disease control.

Official Title
-----------------
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study. P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies. Exclusion Criteria: Hypersensitivity to any component of this medication. History of past or current seizures. History of asthma. Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval. Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.

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

| Intervention/Treatment |
| --- |
|Drug: 3,4 DAP|Recommended maximum dosage: 20mg four times daily and if needed an additional 20 mg per day for a total of 100 mg per day. Drug must be kept refrigerated at all times.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cohort Study of the Clinical Course of Macular Diseases in Japanese

Study Overview
=================
Brief Summary
-----------------
Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.

Official Title
-----------------
Cohort Study of the Clinical Course of Macular Diseases in Japanese Patients

Conditions
-----------------
Macular Disease

Intervention / Treatment
-----------------
* Drug: ranibizumab, aflibercept, pegaptanib, verteporphin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases. Patients who are agreed with the participation of this study. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macular diseases<br>ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡ | Drug: ranibizumab, aflibercept, pegaptanib, verteporphin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial factors associated with visual prognosis in each macular disease |  | Five years after the registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the visual prognosis depending on the treatments in each macular diseases |  | Five years after the registration |