linjc16/ctgov huggingface dataset:
A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness

Study Overview
=================
Brief Summary
-----------------
This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients who have a clinical diagnosis of schizophrenia as documented in their medical records Patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment Patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months Patient has adequate spoken local language Exclusion Criteria: Acute exacerbation of schizophrenia within the last 3 months prior to enrolment Enrolment in an interventional study

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia |  | in the 3 to 12 months prior to screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS) |  | Observational visit Day 1 | 
| Patient health-related quality of life (HRQoL) questionnaires |  | Observational visit Day 1 | 
| Caregiver's burden as assessed by questionnaires |  | Observational visit Day 1 |
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy

Official Title
-----------------
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: SCiP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries. Exclusion Criteria: Intramuscular Botox injection in the past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Arm<br>Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy | Device: SCiP<br>* Noninvasive spinal cord neuromodulator<br>|
| Sham Comparator: Sham Arm<br>Sham Stimulation during Activity Based NeuroRehab Therapy | Device: SCiP<br>* Noninvasive spinal cord neuromodulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stepping overground or on a treadmill |  | 3 months | 
| Gross Motor Functional Measure (GMFM) |  | 3 months |
Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device

Study Overview
=================
Brief Summary
-----------------
Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU).

Official Title
-----------------
Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device: Towards Improving Supervisor Expertise and Decreasing Complications in the Intensive Care Unit

Conditions
-----------------
Procedural Complication

Intervention / Treatment
-----------------
* Device: Eye Tracking Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Novice and expert Invasive bedside procedure (IBP) teachers from Pulmonary Critical Care Medicine and Anesthesia-Critical Care at Mayo Clinic Rochester Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences Novice teachers will include those that have performed less than 50 CVCs Medical student or resident Exclusion Criteria: <25% FTE in the ICU

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical Student or Resident<br>Subjects will perform simulated central venous catheters (CVC) insertions. | |
| Other: Novice and Expert IBP Teachers<br>Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences. Novice teachers will include those that have performed less than 50 CVCs. Teachers will supervise 3 simulated central venous catheters (CVC) insertions with increased complexity while wearing an eye tracking device. | Device: Eye Tracking Device<br>* Eye tracking glasses<br>* Other names: Tobii Pro Glasses 2.0;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixation Frequency | Number of fixations within an area of interest. Higher values indicate focused attention. | Duration of procedure (approximately 4 hours) | 
| Visit Frequency | Number of times an area of interest is entered and left. Indexes which areas repeatedly attracted participant's attention. | Duration of procedure (approximately 4 hours) | 
| Dwell Time | Total fixation duration measured in seconds | Duration of procedure (approximately 4 hours) |
Master's Nursing Programs in Taiwan

Study Overview
=================
Brief Summary
-----------------
The purpose of the study: (1) to understand the models of master education in nursing in Taiwan, including goals, curriculum, and clinical hours…etc). (2) to explore the clinical competencies and career development of the graduates of master's nursing program in Taiwan. Methods: Researchers will collect the data of program goals, curriculum, and clinical hours…etc. from the websites of all nursing schools that provide master's education in nursing in Taiwan. A structured self-report questionnaire will be used to collect the data of the clinical competence and career development of the graduates who have graduated from a master's nursing program in Taiwan in recent 3 years. A third of all eligible subjects will be randomly selected and invited to fill out the questionnaire by the schools that they graduated from.

Official Title
-----------------
The Current Situation and Prospects of Master's Nursing Programs in Taiwan

Conditions
-----------------
Master's Nursing Programs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the graduates who have graduated from a master's nursing program in Taiwan in recent 3 years (2015-2017) The persons who are willing to participate in the study and fill out the questionnaire. Exclusion Criteria: The person who is unable to read and write Chinese. The person who is unable to fill out the questionnaire by him/her-self

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 50 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 |
| --- | --- |
| master's nursing program<br>the graduates of master's nursing program in recent three years in Taiwan | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical competencies of study subjects | Clinical Nurse Specialist Core Competencies Questionnaire will be used for measuring clinical competencies of study subjects. There are 67 items in the questionnaire. The questionnaire employ 5 point Likert-scale. The subject will be asked to assess his/her own clinical competence and choose an appropriate number for each item. The higher number means higher level of clinical competence. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The questionnaire of employment status | Study subjects will be asked to fill out whether they are active practice nurse and the information of their current job, including workplace (such as hospital, community health center, school,…etc.), current job title (such as staff nurse, head nurse, nurse supervisor, clinical instructor, nurse practitioner,…etc.) and full-time or part-time. | up to 24 weeks |
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the exercise protocol called Siriraj home base exercise program for OA knee to usual care and physical modalities for conservative treatment in patients with 1st OA knee.

Official Title
-----------------
A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Other: Siriraj knee exercise
* Other: Physical modalities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1st osteoarthritis of the knee Age >/= 50 yrs Exclusion Criteria: Previous knee surgery for OA knee treatment Has plan or schedule for knee surgery Severe degree of OA knee.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>quadricep exercise | |
| Experimental: Siriraj home base exercise<br>Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise | Other: Siriraj knee exercise<br>* Siriraj knee exercise, 12 position of exercise protocol<br>|
| Active Comparator: Modalities and exercise<br>Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise | Other: Siriraj knee exercise<br>* Siriraj knee exercise, 12 position of exercise protocol<br>Other: Physical modalities<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC score |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 mins walk test |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home base exercise
Long Term Follow-Up Gene Therapy Study for XLRP RPGR

Study Overview
=================
Brief Summary
-----------------
The is a Long-Term Follow-up study assessing safety of patients for up to 60 months following AAV2 vector in participants with XLRP caused by mutations in RPGR.

Official Title
-----------------
Long Term Follow-Up Study of Participants Following an Open Label, Multi-Centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-Associated Virus Vector (AAV2-RPGR) for Gene Therapy of Adults and Children With X-Linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)

Conditions
-----------------
X-Linked Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Biological: AAV-RPGR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received AAV2-RPGR in the MGT009 Study Exclusion Criteria: Unwilling or unable to meet with the requirements of the study

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follow up cohort<br>no intervention follow up study | Biological: AAV-RPGR<br>* Genetic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the long-term safety of AAV2-RPGR vector administered in the MGT009 trial | Safety is defined as the absence of ATIMP-related: Reduction in visual acuity by 15 ETDRS letters or more from MGT009 baseline Severe unresponsive inflammation Infective endophthalmitis Ocular malignancy Grade III or above non-ocular SUSAR | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the longer term efficacy of AAV2-RPGR in improving visual and retinal function, quality of life and protecting against sight impairment from retinal degeneration. | The secondary outcomes are measures of the longer-term efficacy of the original intervention, which will be performed on an individual participant basis and will be descriptive in nature. Efficacy will be assessed at several time points between 12 months and 5 years after the intervention: | Up to 60 Months | 
| Slowing or halting of progressive deterioration in retinal structure or visual function. | OCT and fundus phtotography | Up to 60 Months | 
| Any improvement in visual function from baseline | Measured by visual acuity and visual mobility assessment | Up to 60 Months | 
| Any improvement in retinal function from pre-intervention. | Perimetry tests | Up to 60 Months | 
| Quality of life will be measured by PRO tools | Slowing or halting of progressive deterioration in retinal structure or visual function. Any improvement in visual function from baseline. .EQ5D, IVI and low luminance questionnaires will be administered | Up to 60 Months |
Antiviral Drugs on the Treatment of SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases

Detailed Description
-----------------
Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs

Official Title
-----------------
A Retrospective Study of the Effect of Antiviral Drugs on the Treatment of SARS-CoV-2 COVID19

Conditions
-----------------
Complication of Medical Care, Pneumonia, Viral

Intervention / Treatment
-----------------
* Drug: Favipiravir
* Drug: Remdesivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: main group Patients with COVID19 with medium and easy condition disease take favipiravir/remdisivir control group Patients with COVID19 with medium and easy condition disease not take favipiravir/remdisivir Exclusion Criteria: patients younger 18 severe conditionis

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 |
| --- | --- |
| Complications<br>Evaluathion | Drug: Favipiravir<br>* Antiviral drugs<br>Drug: Remdesivir<br>* Antiviral drugs<br>|
| Oxygen status<br>Evaluathion | Drug: Favipiravir<br>* Antiviral drugs<br>Drug: Remdesivir<br>* Antiviral drugs<br>|
| Oxugen support<br>Evaluathion | Drug: Favipiravir<br>* Antiviral drugs<br>Drug: Remdesivir<br>* Antiviral drugs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome without comlications | The recovery time will be evaluated with and without antiviral drugs retrospectively in homogeneous groups of patients with SARS-CoV2 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Measure | 14 days | 
| SpO2 | Measure | 14 days | 
| Blood pressure | Measure | 14 days | 
| Respiratory rate | Measure | 14 days |
Physician-Patient Communication and Expectations Regarding Ovarian Cancer Prognosis

Study Overview
=================
Brief Summary
-----------------
The primary objective is to administer a cross-sectional survey to directly compare the differences patients and physicians hold regarding ovarian cancer prognosis and survival, complications arising from treatment, and counseling on advance directives, living wills, palliative care, and hospice services. Overall, the project will pinpoint opportunities for better patient physician communication regarding prognosis and end-of-life care and allow for more informed and tailored decision-making.

Official Title
-----------------
Physician-Patient Communication and Expectations Regarding Ovarian Cancer Prognosis

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: Surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women over 18 years old with biopsy-confirmed malignancy being actively treated or are in surveillance for epithelial ovarian cancer have an existing therapeutic relationship with a provider who is participating in the study. Exclusion Criteria: patients enrolled in palliative or hospice care programs, patients with a second primary malignancy within the last five years (excluding non-melanoma skin cancer) patients who are illiterate or non-English speaking, and patients without decision-making capacity. There are no exclusion criteria based on age, gender, economic status or race/ethnicity

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Surveys|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of completed surveys and phone interviews |  | 1 year |
Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

Official Title
-----------------
Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

Conditions
-----------------
Hypertension, Metabolic Syndrome X

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 45 years Increased waist circumference (>88.9cm [>35in] men, >78.7cm [>31in] for women) Elevated triglycerides (>150mg/dl) Low HDL cholesterol (<40mg/dl in men, <50mg/dl in women) Hypertension (>130/>85mmHG) Impaired fasting glucose (>110mg/dl) (8) Hypertensive patient assessed to benefit from telmisartan based treatment Exclusion Criteria: Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients <3 months myocardial infarction (MI), stroke or severe heart failure

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Response Rate at the End of 30 Day Period | Response rate of Blood Pressure assessed in the following categories: Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg | End of 30 day Period | 
| Response Rate at the End of 60 Day Period | Response rate on Blood Pressure: Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline. Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline. Sitting BP normalization < 130 mmHg and DBP < 85 mmHg | At the end of 60 day period | 
| Change in Systolic Blood Pressure (SBP) From Baseline | Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period) | Baseline and 60 days | 
| Change in Diastolic Blood Pressure (DBP) From Baseline | Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period) | Baseline and 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Presence of Metabolic Risk Factor | Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely: a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities, based on patients' Medical History | At the end of 60 day period |