linjc16/ctgov huggingface dataset:
Effects of High-intensity Interval Training in Patients in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of high intensity interval training compared to moderate exercise training and a control group on exercise capacity and quality of life in patients with end stage renal disease on hemodialysis.

Official Title
-----------------
Effects of High-intensity Interval Training in Patients in Hemodialysis

Conditions
-----------------
Chronic Renal Disease

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on hemodialysis ≥ 3 months Exclusion Criteria: Acute infection Systolic BP>180 mmHG or diabolic BP>105 mmHG Unstable angina pectoris Serious rhythm disturbances Hyperkalemic (> 6 mmol/L), Unstable diabetes mellitus Wheelchair Dialyses access on lower extremities Haemoglobin < 9 g/dl

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Exercise<br>High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak) | Other: exercise<br>* Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group<br>|
| Active Comparator: B: Execise<br>Moderate continuous exercise training | Other: exercise<br>* Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group<br>|
| No Intervention: C: Controll<br>Usual care without exercise training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake | Canges from baseline in peak oxygen uptake at 16 weeks | baseline, 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Hemodialysis, Physical therapy, high-intensity
The Study of the Impact of Disclosing Imaging Study Information to Trial Participants

Study Overview
=================
Brief Summary
-----------------
The overall goal of the study is to evaluate how research participants in Parkinson Disease studies that include brain imaging with a dopamine transporter ligand choose to receive the imaging data and what is the impact of the imaging data information on the management of their symptoms.

Detailed Description
-----------------
Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.

Official Title
-----------------
Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials

Conditions
-----------------
Parkinsonian Syndrome, Parkinson

Intervention / Treatment
-----------------
* Behavioral: A series of questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in imaging study as described within the protocol Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: A series of questionnaires|Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.|

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
-----------------
Parkinson, Imaging
A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-

Study Overview
=================
Brief Summary
-----------------
To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)

Official Title
-----------------
An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).

Conditions
-----------------
Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host Disease

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient had enrolled in GVHD prophylaxis study. Patient had been fully informed. Exclusion Criteria: The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus|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
-----------------
Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease
An Observational Study of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype

Study Overview
=================
Brief Summary
-----------------
This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).

Detailed Description
-----------------
The objective of this study is to characterize key aspects of the clinical presentation, disease phenotype and progression of patients with late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD) including, but not limited to, age of presentation, onset of hepatomegaly, progression over time of liver function, and stability of lipid abnormalities.

Official Title
-----------------
An Observational Study of the Clinical Characteristics and Disease Progression of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype

Conditions
-----------------
Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with late onset LAL Deficiency/ Cholesteryl Ester Storage Disease (CESD) who are 5 years of age or older and have required data points in their medical record Exclusion Criteria: Required data points for inclusion are not available

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |
| Clinical History Summary | Characterize patient demographic data and clinical course of disease using descriptive statistics. | Expected average of 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lysosomal Storage Disease, Late Onset Lysosomal Acid Lipase (LAL) Deficiency, Acid cholesteryl ester hydrolase deficiency, type 2, Acid lipase disease, Cholesterol ester hydrolase deficiency, LAL Deficiency, LIPA Deficiency, Wolman disease
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

Official Title
-----------------
SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System

Conditions
-----------------
Abdominal Aortic Aneurysm, AAA

Intervention / Treatment
-----------------
* Device: Endovascular abdominal repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must comply with the indications for use Patient must have an infrarenal aortic aneurysm with diameter >5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months Patient must be available for the appropriate follow-up times for the duration of the study Patient has signed the informed consent before intervention Exclusion Criteria: Patients with one of the contraindications as indicated in the instructions for use Patients with infectious aneurysm Patients with inflammatory aneurysm Patients with pseudoaneurysm Patients with ruptured or traumatic aneurysm Patients with suprarenal, juxtarenal, or pararenal aneurysm Patients with aortic dissection Patients with a reversed conical neck that is defined as a >3mm distal increase over a 15mm length Patients who have a congenital degenerative Collagen disease or connective tissue disorder Patients with thrombocytopenia Patients with creatinine >2.4 mg/dl immediately before the Intervention Patients with hyperthyreosis Patients with malignancy needing chemotherapy or Radiation Patients who are enrolled in another clinical study Patients with life expectancy of less than 24 months

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 |
| --- |
|Device: Endovascular abdominal repair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of aneurysm rupture and aneurysm related death |  | 2 years |
Lymphedema in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery. Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.

Official Title
-----------------
A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery

Conditions
-----------------
Lower Extremity Lymphedema, Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women older than 18 years old, endometrial cancer, suitable candidates for surgery, scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC), no severe physical or mental comorbidity Exclusion Criteria: metastatic disease, laparotomy

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

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

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 |
| --- | --- | --- |
| change in incidence of lower-extremity lymphedema |  | 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lymphedema-related morbidity |  | 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer |
Stroke Ready - Optimizing Acute Stroke Care

Study Overview
=================
Brief Summary
-----------------
The study aims to increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of hospital and community level interventions. It also aims to inform future stroke preparedness interventions by exploring the relative importance of hospital optimization and community interventions.

Official Title
-----------------
Stroke Ready - Optimizing Acute Stroke Care

Conditions
-----------------
Stroke, Acute, Stroke

Intervention / Treatment
-----------------
* Behavioral: Stroke Ready


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.

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
Intervention Model: Sequential Assignment
Interventional Model Description: Stroke Ready is a stepped wedge design to be delivered to each of the four Flint community quadrants over the course of 2 years.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke Ready Community intervention<br>We divided the Flint community into four quadrants. We will focus our workshops and posters on one quadrant, but not exclusively, moving quadrants every 6 months over the course of two years. | Behavioral: Stroke Ready<br>* Stroke Ready community intervention consists of peer facilitated educational workshops, stroke music video, and mass media campaign including print materials (e.g. posters, brochure), health promotion mailers, radio/Television public health service announcements, and the Stroke Ready website and Facebook page.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute stroke treatment rate (tPA) | Acute stroke treatment rate - community wide. Retrospective data captured through medical record review | Time frame: 11 years of data will be reviewed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of emergency department arrivals by ambulance | Optimize community for acute stroke (community level)--retrospective data captured through medical record review | Time frame: 11 years of data will be reviewed |
A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified: To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs). To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

Detailed Description
-----------------
This study will engage up to 20 participants with TN through patient associations or HCPs. The study will be conducted in English Speaking countries. The study comprises the following parts : Participants Recruitment Completion of the Diary Qualitative interviews with participants Analysis of qualitative research to assess content validity Secondary analysis as a workshop with a panel of experts to finalize the diary The diary will be provided to each participant and to HCPs. Participants will be requested to follow the instructions, use the diary and provide their feedback on the diary.

Official Title
-----------------
A Study to Validate a Diary Developed by Noema Pharma That Will be Used for Future Trigeminal Neuralgia Clinical Research Studies to Capture Pain Dimensions.

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Other: Pain Diary use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female aged of 40 years or more. Must be able to read, write, and speak English to complete the consent process and participate in an interview. Able and willing to provide consent for participation in the study, and to allow the study team to access their data entries including audio or video recordings. - - Participant with a current or previous diagnosis of TN Willing to participate in up to 30 minutes remote interviews or in-person interview (this interview will be recorded by the HCP) Committ to fill in the diary according to the HCP instruction Exclusion Criteria: Not applicable

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pain Diary use|Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concept elicitation of the diary content | During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience | 1 day | 
| Measure of pain associated with Trigeminal Neuralgia | Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia | 2 weeks |
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.

Official Title
-----------------
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: Intensity modulated radiation therapy, Radical cystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bladder urothelium carcinoma cT2-4aN0M0 life expectancy≥1 year ECOG PS 0-1 have no previously received radiotherapy or chemotherapy have no major organ dysfunction have been provided informed written consent Exclusion Criteria: extensive carcinoma in situ or ureter invaded distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis have severe major organ dysfunction cannot finish treatments because of other severe diseases or life expectance≤6 months exist other malignant tumors have severe coagulation disorders no other trails participated in 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Arm<br>Patients who have response to neoadjuvant chemotherapy will be separated into two groups (GI cT0-1 and G2 ≥cT2). G1receive concurrent radiochemotherapy, and G2 receive partial resection of the bladder+lymphadenectomy+adjuvant radiotherapy.Patients who have no response to neoadjuvant chemotherapy or disagree to receive the sequential treatment will receive the radical resection of bladder. | Procedure: Intensity modulated radiation therapy, Radical cystectomy<br>* Postoperative Intensity modulated radiation therapy(IMRT) will be applied to effective team.Radical cystectomy will be applied to ineffective team.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder preservation rate | bladder preservation rate | 3 years |