linjc16/ctgov huggingface dataset:
Integrated Supported Employment in Mainland China

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial, the researchers investigated the effectiveness of integrated supported employment (ISE) as compared with individual placement and support (IPS) and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland China.

Detailed Description
-----------------
One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n = 54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure, and psychological outcomes were conducted at admission, completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.

Official Title
-----------------
Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Integrated Supported Employment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older; Diagnosis of schizophrenia for at least 2 years Being unemployed Willing to give informed consent Having no obvious cognitive, learning, or neurological impairment Having completed primary school education Having a desire to work Exclusion Criteria: • Having score lower than 18 on the 30-item Mini-Mental State Examination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Supported Employment<br>Individual placement support intervention plus work-related social skills training | Other: Integrated Supported Employment<br>* vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement<br>|
| No Intervention: Individualised Placement Support<br>Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities | |
| No Intervention: Traditional Vocational Rehabilitation<br>general pre-vocational training and placement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment rate | employment status, employed or unemployed | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Job tenure, duration | how long the job lasts | completion of the 3-mo program, and follow-up at 7, 11, and 15 mo. |
Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test

Study Overview
=================
Brief Summary
-----------------
To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.

Detailed Description
-----------------
De-identified banked genomic DNA samples derived from whole blood from subjects with suspected thrombophilia will be collected from one or more clinical sites. Three clinical laboratory sites will analyze the samples with the FII/FVL Test. Bi-directional DNA sequencing will be performed on all samples at an independent core reference laboratory.

Official Title
-----------------
A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia

Conditions
-----------------
Factor V Leiden, Factor II, Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected thrombophilia 18 years of age or older Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Performance of the MassPLEX Factor II/V Leiden Test | Overall percent agreement of the FII/FVL Test results to the bi-directional DNA sequencing results. | Samples are collected at time of suspected thrombotic event. |
Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing major non cardiac surgery, during and after the continuous infusion of levosimendan or dobutamine.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Levosimendan
* Drug: Dobutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: EF < 40%, no liver and renal disfynction, chronic cardiopathy Exclusion Criteria: acute coronary syndrome, life expectation <30 days, hemodialysis, ventricular tachycardia/ventricular fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dobutamine<br>patient receiving dobutamine | Drug: Dobutamine<br>* patient receiving dobutamine<br>|
| Active Comparator: Levosimendan<br>patient receiving levosimendan | Drug: Levosimendan<br>* patient receiving levosimendan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index |  | 1-3 days |
German Pediatric Hemophilia Research Database

Study Overview
=================
Brief Summary
-----------------
The German Pediatric Hemophilia Research Database will collect data on the prophylactic and therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL) and living circumstances in newly diagnosed children with hemophilia.

Official Title
-----------------
German Pediatric Hemophilia Research Database

Conditions
-----------------
Hemophilia A, Hemophilia B, Children, Drug Specific Antibodies

Intervention / Treatment
-----------------
* Other: documentation only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemophilia A or B FVIII/FIX <1% to 25% informed consent Exclusion Criteria: no consent

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| newly diagnosed children with hemophilia<br>no intervention | Other: documentation only<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with antibody developement to exogenous clotting factors (>0.5 BU) | Blood Test: measurement in Bethesda Units, positive according to local standards, for most labs > 0.5 BU | 5 years |
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Official Title
-----------------
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1446


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical healthy volunteers weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2 Exclusion Criteria: History of any clinically significant disease or disorder. History of severe allergy/hypersensitivity reactions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1446 Oral or placebo<br>Single oral administration of AZD1446 or placebo | Drug: AZD1446<br>* oral, single dose<br>|
| Experimental: AZD1446 Oral, with or without food<br>Single oral administration of AZD1446 with or without food | Drug: AZD1446<br>* oral, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables |  | From first to last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the single ascending dose pharmacokinetics of AZD1446 |  | PK sampling taken at defined timepoints during residential period | 
| Determine the single dose of AZD1446 on food interaction |  | From first to last visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
single dose, pharmacokinetics, safety, healthy volunteers, food interaction, AZD1446
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Study Overview
=================
Brief Summary
-----------------
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.

Official Title
-----------------
A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Conditions
-----------------
Candidiasis, Esophageal, HIV Infections

Intervention / Treatment
-----------------
* Drug: Ketoconazole
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Prior Medication: Allowed: Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Evidence of noncandidal systemic fungal infections. Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study. Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria. Leukemia requiring chemotherapy. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment. Concurrent Medication: Excluded: Warfarin. Immunostimulants. Interferon. Oral or topical antifungal agents. Concurrent Treatment: Excluded: Lymphocyte replacement. Patients with the following are excluded: History of allergy to imidazoles. Abnormalities which may preclude esophagoscopy or endoscopy before or during the study. Inability to tolerate fluconazole or ketoconazole. Inability or unwillingness to give written informed consent. Life expectancy < 2 months. Prior Medication: Excluded: Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole. Warfarin. Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia. Illicit or illegal drug use.

Ages Eligible for Study
-----------------
Minimum Age: 13 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketoconazole|nan|
|Drug: Fluconazole|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
-----------------
AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
Pharmacological Treatment of Presbyopia

Study Overview
=================
Brief Summary
-----------------
In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.

Official Title
-----------------
Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops

Conditions
-----------------
Near Vision

Intervention / Treatment
-----------------
* Drug: Pilocarpine 1.25% Eye drop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR Patients with the symptom of blurred vision at near distance Exclusion Criteria: Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilocarpine Therapy<br>The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group, | Drug: Pilocarpine 1.25% Eye drop<br>* One millimeter of pilocarpine eye drop (Bakhtarbiochemistry Company, Iran) contains pilocarpine hydrochloride 1.25% (12.5 mg) as an active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. The medication preservative is 0.0075% benzalkonium chloride. Inactive ingredients in the ophthalmic are boric acid, sodium citrate dihydrate, sodium chloride, purified water. Another pilocarpine eye drop was Vuity® (1.25% pilocarpine; Allergan company) contains the active intergradients of pilocarpine hydrochloride 1.25% (12.5 mg/mL), equivalent to 1.06% (10.6 mg/mL) pilocarpine free-base and the preservative agents was 0.0075% benzalkonium chloride.<br>|
| No Intervention: Without Pilocarpine Therapy<br>The left eyes of the patients will be defined as the controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of near vision after one hour following pilocarpine eye drop | The near vision will be measured based on the LogMAR vision at a distance of 33cm before and one hour after instillation of 1.25% pilocarpine eye drop. | baseline to one hour after pilocarpine insillation |
Comparison of Synchrony Between 4 NIV Ventilators

Study Overview
=================
Brief Summary
-----------------
Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2 ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients admitted in the intensive care unit for respiratory failure and treated with NIV.

Official Title
-----------------
Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort

Conditions
-----------------
Respiratoy Failure Requiring NIV Treatment

Intervention / Treatment
-----------------
* Device: V-PAP III ventilator
* Device: Stellar 150 ventilator
* Device: BiPAP vision ventilator
* Device: V60 ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory failure Exclusion Criteria: Severe hypoxemia requiring an FiO2 > 0.6 Hemodynamic instability : defined as a variation of > 20% in mean arterial pressure (MAP) and heart rate (HR) during the previous 2 hours; the need for high doses of catecholamines (namely > 0.5 mcg/kg/min) and/or the need of major volume resuscitation (more than 2 liters of fluids in 2 hours) Impaired consciousness or absence of patient cooperation; Facial or laryngeal lesions contraindicating the use of NIV; Poor short term prognosis. Age < 18 years old

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

| Intervention/Treatment |
| --- |
|Device: V-PAP III ventilator|nan|
|Device: Stellar 150 ventilator|nan|
|Device: BiPAP vision ventilator|nan|
|Device: V60 ventilator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-ventilator synchrony | Patient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort of patient under NIV | Patient's confort during NIV will be assessed using a visual analogic scale. |  | 
| Ventilatory parameters | Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow. |  |
Serious Game for Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.

Official Title
-----------------
Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Serious game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Gait and balance disorders Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year). Exclusion Criteria: Dementia Ongoing severe medical condition that prevented assessments

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation with serious game<br>18 rehabilitation sessions with serious game during a 6-8 weeks period | Other: Serious game<br>* Rehabilitation with serious game<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility questionnaire | self-assessment questionnaire | once a week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability questionnaire | self-assessment questionnaire | once a week | 
| biomechanical parameters of gait and balance | recordings of centres of foot and mass displacements and velocities | at inclusion, 3 weeks, 6 weeks and 18 weeks | 
| kinematics parameters of gait and balance | range of motion of hip, knee and ankle angles | at inclusion, 3 weeks, 6 weeks and 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait and balance disorders, serious game