linjc16/ctgov huggingface dataset:
Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.

Official Title
-----------------
Observational Study to Assess Ease of Use, Acceptability and Preference of Norditropin NordiFlex® With NordiFlex PenMate™ in Subjects on Prescribed Growth Hormone Therapy

Conditions
-----------------
Delivery Systems, Growth Hormone Disorder, Growth Hormone Deficiency in Children

Intervention / Treatment
-----------------
* Device: NordiFlex PenMate™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the physician decision has been made to use Norditropin Nordiflex® growth hormone therapy in accordance with the locally approved labelling, any subject is eligible for the study, including newly diagnosed subjects who have never received growth hormone therapy before and subjects who were treated with the other growth hormone products (with exclusion of patients who received previously Norditropin Nordiflex®) and need to be switched to a new product. The selection of the subjects will be at the discretion of the individual physician Exclusion Criteria: Contraindications to Norditropin® growth hormone therapy Subjects who have received Norditropin NordiFlex® prior to this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PenMate device<br> | Device: NordiFlex PenMate™<br>* Subjects whom will be offered growth hormone (Norditropin NordiFlex®) on prescription as part of normal clinical practice will be asked to evaluate the NordiFlex PenMate™ device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that find growth hormone injection using Norditropin Nordiflex® with NordiFlex PenMate™ very easy or easy as assessed by patient/parent questionnaire |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires |  | Week 0 | 
| Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire |  | Week 12 | 
| Compliance to treatment as assessed by patient/parent diary |  | Week 12 | 
| Evaluation of tolerability, when using Norditropin Nordiflex® with NordiFlex PenMate™, by collecting Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) and clinical technical complaints |  | Week 12 |
Prevalence of Dynamic Instability Among Football Players in the UAE: A Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to determine dynamic instability prevalence in United Arab Emirates football players.

Official Title
-----------------
Prevalence of Dynamic Instability Among Football Players in the UAE: A Cross-sectional Study

Conditions
-----------------
Football Players

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 16-24 years . Exclusion Criteria: previous injury in lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 24 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall stability index | overall stability index was measured by using biodex balance system. by asking each participant to stand on biodex plateform trying to keep his balance while standing on one leg | 3 months |
Radial Artery Function Following Trans-radial Cardiac Catheterisation

Study Overview
=================
Brief Summary
-----------------
The investigators will study Radial artery injury and endothelial function following trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post- angiography using Optical Coherence Tomography. The participants will also have radial endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week, one month and three months post- angiography. Blood will be taken pre and 24 hours post angiography for characterisation of endothelial progenitor cell numbers and function. The hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated dilatation which peaks at 24 hours and recovers at three months. The investigators hope to correlate the rate of this recovery with peri-procedural progenitor cell numbers.

Official Title
-----------------
Radial Artery Function Following Trans-radial Cardiac Catheterisation

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Procedure: Coronary angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation Exclusion Criteria: Recent myocardial infarction (<3 months) Severe aortic stenosis Chronic renal failure (eGFR<30) Inability to give informed consent

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients post- cardiac catheterisation<br> | Procedure: Coronary angiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow-mediated dilatation | Radial artery flow-mediated dilatation will be assessed at the above stated time points | baseline, 24 hours, one week, four weeks and three months post-angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery injury | Optical coherence tomography examination of the radial artery will be made at baseline and following sheath insertion. | Baseline and up to 1 hour Post angiograpy sheath insertion | 
| Endothelial progenitor cell number an function Endothelial progenitor cell number and function |  | Baseline and at 24 hours post-angiogram |
Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34%   50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.

Conditions
-----------------
HepatoCellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC with no preoperative RT resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function compensated cirrhosis or no cirrhosis; Child-Pugh A ECOG Performance Status of 0 or 1. Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry Exclusion Criteria: unresectable hepatocellular carcinoma patients Hepatocellular carcinoma without portal vein tumor thrombus Hepatectomy without narrow margin(more than 1cm) presence of distant metastasis palliative resection with tumor residual non-HCC confirmed by postoperative pathology
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RT<br>Resectable HCC patients adjuvant RT for PVT or NM | |
| No RT<br>Resectable HCC patients adjuvant other treatment for PVT or NM | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1year |
Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam

Study Overview
=================
Brief Summary
-----------------
Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Detailed Description
-----------------
Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Official Title
-----------------
Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam

Conditions
-----------------
Coronary Artery Disease, Chest Pain

Intervention / Treatment
-----------------
* Procedure: Additional rest and stress image sets on new camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral for cardiac stress testing with SPECT myocardial perfusion imaging Exclusion Criteria: refusal to provide written informed consent or lack capacity to provide informed consent

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 |
| --- |
|Procedure: Additional rest and stress image sets on new camera|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
-----------------
myocardial perfusion, Imaging
Xarelto [SPAF] Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice. A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Official Title
-----------------
Special Drug Use Investigation of Xarelto [SPAF]

Conditions
-----------------
Brain Ischemia

Intervention / Treatment
-----------------
* Drug: Rivaroxaban(Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made Patients without experience of using Xarelto prior to the study Exclusion Criteria: Patients who are contraindicated based on the product label

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Group 1<br>Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism | Drug: Rivaroxaban(Xarelto, BAY59-7939)<br>* Patients treated with Xarelto under practical manner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin) |  | Up to 2 years | 
| Incidence of events of stroke |  | Up to 5 years | 
| Incidence of events of non-central nervous system embolism |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey |  | Baseline | 
| Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey |  | Baseline | 
| Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xarelto, SPAF
A Prospective, Noninterventional, Observational Study of Late-Onset Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Study 701-901, a multicenter, multinational, longitudinal, non-interventional observational study in subjects, at least 18 years old, diagnosed with late-onset Pompe disease prospectively collects data to understand clinical progression in terms of respiratory function, symptomology, genotype, biochemistry, endurance and selected subject-reported measures for 24 weeks followed by a 240 week additional observation period for up to 100 subjects.

Official Title
-----------------
A Prospective, Noninterventional, Observational Study of Late-Onset Pompe Disease

Conditions
-----------------
Late-onset Pompe Patients Untreated or Treated With rhGAA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent after the nature of the study has been explained and prior to any study-related procedure Diagnosed with late-onset Pompe disease based on current or previous genomic testing and/or endogenous GAA activity At least 18 years of age at study entry Willing and able to comply with all study procedures Exclusion Criteria: Requires non-invasive ventilatory support while awake and in the upright position Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise study completion or data collection Unable to perform baseline efficacy assessments

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 |
| --- | --- |
| Observational<br>No interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the degree of change in respiratory and endurance endpoints over time in patients with Pompe disease |  | 264 Weeks |
The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery

Detailed Description
-----------------
Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

Conditions
-----------------
Airway Extubation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal saline 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20, ASA class I and II, nasal surgery Exclusion Criteria: bradycardia (< 45 bpm), heart block, liver failure, renal failure, uncontrolled hypertension, body mass index ≥ 30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Drug: Normal saline 0.9%<br>* Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation |  | 20min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of recovery |  | 1 day |
Quality Assurance of Cognitive-behavioral Therapy

Study Overview
=================
Brief Summary
-----------------
The study examines associations between competence in cognitive-behavioral therapy (CBT) and adherence to evidence-based generic CBT in therapists and treatment outcome in patients with depression or an anxiety disorder in psychiatric outpatient care.

Official Title
-----------------
Quality Assurance of Cognitive-behavioral Therapy: Adherence and Competence in Therapists and Treatment Outcome in Patients With Depression and Anxiety

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

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder) Exclusion Criteria: Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive-behavioral therapy|Individual cognitive-behavioral therapy, including homework and behavioral change methods.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disorder-specific self-reported symptoms change instruments | Symptoms measures of depression or an anxiety disorder | Change from baseline symptoms at 18 weeks |
The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection

Study Overview
=================
Brief Summary
-----------------
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of disease.

Detailed Description
-----------------
Patients who were recently diagnosed with C. difficile infection will undergo assessment of both before treatment and after completing treatment to study the presence of C. difficile in the colonic mucosa pre as well as assessment for microbiome and patient/clinical factors that may contribute to disease recurrence. Assessment will include sigmoid colon biopsies, blood draw, stool samples and surveys.

Official Title
-----------------
The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection

Conditions
-----------------
Clostridioides Difficile Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 and over Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea Exclusion Criteria: Known active pregnancy Prior diagnosis of C. difficile infection within 2 months of this diagnosis Other known active gastrointestinal infectious process Vulnerable adults Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes

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 |
| --- | --- | --- |
| Disease recurrence | Based on clinical stool testing and symptoms | 8 weeks post treatment of C.difficile infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mucosal presence of C. difficile | Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples | Baseline, approximately 1-14 days post treatment of C. difficile infection |