linjc16/ctgov huggingface dataset:
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Official Title
-----------------
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Conditions
-----------------
Ketosis, Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: KetoneAid KE4 Pro Monoester
* Dietary Supplement: Science in Sport Go Enegy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40% Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients are studied in a randomized single-blind cross-over design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone Monoester<br>Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) | Dietary Supplement: KetoneAid KE4 Pro Monoester<br>* A dietary supplement containing ketone monoester.<br>|
| Placebo Comparator: Placebo Treatment<br>Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm. | Dietary Supplement: Science in Sport Go Enegy<br>* Dosis isocaloric to the KetoneAid Arm<br>|
| Active Comparator: Ketone Monoester in presence of low-dose insulin clamp<br>Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism | Dietary Supplement: KetoneAid KE4 Pro Monoester<br>* A dietary supplement containing ketone monoester.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output (L/min) | Change in Cardiac output measured by Swann-Ganz Catherization during study period, | 3 hours - Area under the curve | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction | Change in LVEF measured by echocardiography during study periode | 3 hours - Area under the curve | 
| Blood Ketones | Change in blood Ketones measured by venous blood samples | 3 hours | 
| Blood pH | Change in venous blood pH during the study period | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodynamics
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

Study Overview
=================
Brief Summary
-----------------
The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.

Official Title
-----------------
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

Conditions
-----------------
Vascular Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Device: HDH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age above 18 (men and woman) Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm The abdominal aneurysm neck is longer than 1.5 cm Patient's physical condition allows performing general anesthesia Patient is willing to sign the informed consent and follow the study protocol. Exclusion Criteria: Patient Age under 18 years Patient's physical condition dose not allows to perform general anesthesia Patient's with terminal disease and life expectancy of less than 3 months Patient objects to the treatment or study protocol Anesthesiologist or personal care physician object Patient suffer from Supra/infrarenal AAA The abdominal aneurysm neck is smaller than 1.5 cm Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aortic anastomosis surgery will be conducted using HDH device. | Device: HDH<br>* sutureless vascular anastomosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events. |  | within 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete the anastomosis |  | during the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sutureless vascular bypass
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.

Official Title
-----------------
Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Conditions
-----------------
Perennial Allergy to House Dust Mite and/or Cat

Intervention / Treatment
-----------------
* Drug: CYT003-QbG10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens Exclusion Criteria: Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments. Use of any concomitant medication that could affect the patient's study treatment response or assessment results. Any clinically relevant concomitant disease as judged by the investigator. Pregnancy or female planning to become pregnant during the study.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>|
| Placebo Comparator: 2<br> | Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life |  | on 4 occations over 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the vaccine by collection of adverse events |  | at each visit |
Eastern Caribbean Health Outcomes Research Network (ECHORN)

Study Overview
=================
Brief Summary
-----------------
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.

Detailed Description
-----------------
The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad & Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD.

Official Title
-----------------
Eastern Caribbean Health Outcomes Research Network (ECHORN)

Conditions
-----------------
Cancer, Cardiovascular Disease, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 40 years of age English or Spanish language speaking Resident of island at least 10 years Able to provide informed consent Non-institutionalized at the time of data collection Stable contact/residential information No plans to relocate from island within the next 5 years

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

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

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 |
| --- | --- | --- |
| Prevalence of non-communicable diseases | Prevalence of non-communicable diseases, including cancer, heart disease and diabetes. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, cardiovascular disease, diabetes
Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia

Study Overview
=================
Brief Summary
-----------------
A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impact and importance of vaccination among cancer survivors.

Official Title
-----------------
Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia

Conditions
-----------------
Covid19, Vaccination Refusal, Survivorship

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female cancer survivors or care-taker undergoing national covid 19 vaccine - Exclusion Criteria: Male, not cancer survivors -
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 |
| --- | --- | --- |
| Vaccination refusal | Number of cancer survivors refuse vaccine | 8 months | 
| Reason for Refusal of Vaccine | Number of cancer survivors refuse vaccine | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Vaccination, Gynaeoncology cancer, Cancer survivor
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic

Study Overview
=================
Brief Summary
-----------------
Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

Detailed Description
-----------------
Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state. A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer from cardiovascular disease, osteoarthritis, respiratory diseases and many others.

Official Title
-----------------
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic

Conditions
-----------------
D001452

Intervention / Treatment
-----------------
* Behavioral: Psychological measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled in balneological treatment Exclusion Criteria: not enrolled in the balneological treatment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Longitudinal Study<br>A longitudinal study of anxiety over the balneological treatment. | Behavioral: Psychological measurement<br>* Psychological assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Anxiety | Low level of anxiety | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balneology, anxiety, fear of SARS-CoV-2, resilience, general trust
Surgical Therapy and Survival in HCC/ C.F. Zhang et al.

Study Overview
=================
Brief Summary
-----------------
This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of surgery. The SEER database, which is one of the most comprehensive and authoritative databases concerning cancer, was used to estimate the survival benefit of patients who underwent local tumor destruction (LTD), wedge or segmental resection (WSR), lobectomy resection (LR), liver transplantation (LT), or non-surgery. This study discovered surgery offered a survival benefit compared with non-surgery for young patients with stage I-II HCC. Furtherly, LT is associated with superior survival than WSR, LR and LTD in those patients. Our results facilitate the selection of surgical strategies.

Detailed Description
-----------------
The SEER data contain no identifiers and are publicly available for studies of cancer-based epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from Institutional Review Board approval and the need for informed consent was waived. The submitted magazine requires registration on the website, so this operation is needed.

Official Title
-----------------
Surgical Therapy and Survival in Young Patients With Stage I-II Hepatocellular Carcinoma: A Retrospective Cohort Study

Conditions
-----------------
Hepatocellular Carcinoma, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed with colorectal cancer only; Patients with simultaneous metastasis of liver and lung cancer cells; Patients without metastasis resection; whether they underwent palliative primary tumor resection was known; Their cause of death was known; Their survival time were known and greater than 0 month; Patients were diagnosed with microscopic confirmation. Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- | --- |
| Overall survival | Overall survival was defined as the duration between the surgery and death or the last follow-up | 2004.1.1-2013.12.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific survival | Cancer-specific survival was defined as the period between the surgery and death due to cancer to reduce the impact of life-threatening comorbidities. | 2004.1.1-2013.12.31 |
[Trial of device that is not approved or cleared by the U.S. FDA]

Study Overview
=================

Official Title
-----------------
[Trial of device that is not approved or cleared by the U.S. FDA]

Participation Criteria
=================

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


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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intense Monitoring Study on Tyvyt

Study Overview
=================
Brief Summary
-----------------
The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.

Official Title
-----------------
Intense Monitoring Study on Sintilimab Injection (Tyvyt®)

Conditions
-----------------
Relapsed or Refractory Classical Hodgkin's Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be able to understand and voluntarily sign the informed consent form (ICF). Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up. Patients must have agreed to use Tyvyt® to treat the target indication. Exclusion Criteria: Patients refuse to be included in the study or refuse to cooperate. Patients have participated in another interventional studies within 4 weeks prior to enrollment.
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 |
| --- | --- | --- |
| Incidence of known adverse drug reactions |  | During the actual Tyvyt treatment time. | 
| Occurrence of new adverse drug reactions |  | During the actual Tyvyt treatment time. | 
| Association, risk factors, severity and incidence of immune-related adverse drug reactions/events |  | During the actual Tyvyt treatment time. | 
| Association, risk factors, severity and incidence of serious adverse drug reactions |  | During the actual Tyvyt treatment time. | 
| Occurrence of adverse drug reactions in special population |  | During the actual Tyvyt treatment time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | During the actual Tyvyt treatment time. |
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study

Study Overview
=================
Brief Summary
-----------------
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.

Detailed Description
-----------------
Specific objectives : To determine the incidence of complications occurring in the first year after implantation of a pacemaker. To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation. To determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year. To determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent. To determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).

Official Title
-----------------
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study

Conditions
-----------------
Arrhythmia, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study. Exclusion Criteria: Patients are not eligible if they refuse to sign informed consent on use of personal medical data. Patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker Patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Pacemaker, routine, follow-up, complications, Quality of Life