linjc16/ctgov huggingface dataset:
Effect of Training Intensity on Health Outcomes in Diabetes

Study Overview
=================
Brief Summary
-----------------
The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.

Official Title
-----------------
Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (<2 hours pr. week) BMI <35 kg/m2 Exclusion Criteria: Smoking Prior cardiavascular diseases Alcohol intake 14> units pr. week.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate intensity training<br>Moderate continuous exercise three times pr. week for 50 min. | Behavioral: Training<br>* The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.<br>|
| Experimental: High intensity training<br>High intensity interval training three times pr. week for 15 min. | Behavioral: Training<br>* The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Long term blood glucose levels | From baseline measure to post test: 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test | 75gr glucose is ingested, bllod sampling over the following two hours | From baseline measure to post test: 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Study Overview
=================
Brief Summary
-----------------
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.

Detailed Description
-----------------
This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.

Official Title
-----------------
CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Biological: CLBS119


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test Receiving or received ventilatory support for COVID-19 pneumonia/ARDS Evidence for ongoing pulmonary involvement based on P/F ratio <300 Able to provide informed consent Exclusion Criteria: Immunocompromised or current use of immunosuppressive agents other than corticosteroids History of autoimmune disease Evidence of multiorgan failure Subject is pregnant or lactating at the time of signing the consent Participation in any other clinical trial of an experimental treatment for COVID-19 History of sickle cell disease

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: CLBS119 Active Treatment<br>Single administration of CLBS119 | Biological: CLBS119<br>* Peripheral blood derived autologous CD34+ cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Through end of study (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxygen saturation |  | Change from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, COVID, SARs-CoV-2, Pulmonary Inflammation, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases, Respiratory Insufficiency, ARDS, pandemic, Corona Virus Infection, Coronavirus
Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve.

Official Title
-----------------
Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Conditions
-----------------
Stomach Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients were 18-90 years old 2. Patients with a documented diagnosis of gastric adenocarcinoma 3. patients were scheduled to undergo minimally invasive gastric cancer surgery 4.patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound Exclusion Criteria: 1. Patients with neoadjuvant treatment 2. Patients procedure concurrent with the gastrectomy 3.Patients with palliative surgery 4. Patients with the contraindications for general anesthesia 5. Patients were pregnant or mentally incompetent 6. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Operation time,min | The surgeon begins the operation until the incision is closed | 1 week | 
| Docking time,min | From the skin cutting through the observation hole to the robot moving to the designated position, the lens and the instrument arm enter the abdominal cavity and prepare for this period | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated blood loss ,ml | The amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze | 1 week | 
| Number of retrieved lymph nodes | Refer to the postoperative pathology report | 1 week | 
| Day of ﬁrst ﬂatus,day |  | 2 week | 
| Day of ﬁrst ﬂuid diet,day |  | 2 week | 
| the rate of postoperative complications | Postoperative complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage | 30 days after the operation | 
| postoperative hospital stay, days | Length of postoperative hospital stay | 30 days after the operation | 
| cost | total cost in the hospital | 30 days after the operation |
Limited-English Proficiency (LEP) Virtual Reality (VR) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations with limited English proficiency (LEP).

Official Title
-----------------
Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations

Conditions
-----------------
Anxiety, Parents, Language

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 0-99 (Child participants will be ages 0 to 17. Parents of children of any age may also be enrolled) Able to consent Self-identified as having a limited English proficiency or English-proficiency Exclusion Criteria: People who do not consent Significant Cognitive Impairment History of Severe Motion Sickness Current Nausea Seizures Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br> | Behavioral: Virtual Reality<br>* Virtual Reality headset with calming scenery<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural-Related Anxiety | Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality) | Duration of intervention, approximately 20-30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality
Debate on Progesterone Elevation on the Day of Triggering

Study Overview
=================
Brief Summary
-----------------
The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology. This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016. All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.

Official Title
-----------------
The Neverending Debate on Progesterone Elevation: Possible Solutions

Conditions
-----------------
Progesterone, ART, Female Infertility, Embryo Transfer

Intervention / Treatment
-----------------
* Other: embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5) Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc) Exclusion Criteria: thawed embryo transfers deriving from PGTA.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cleavage stage embryo<br>embryo which is on day 2 or 3 | Other: embryo transfer<br>* Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy<br>|
| blastocyst embryo<br>embryo which is on day 5 | Other: embryo transfer<br>* Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of PE on CPR and LBR | To evaluate the impact of premature high serum P levels on the outcome of fresh embryo transfer cycles in terms of Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR). | January 2012-December 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst embryo transfers' outcomes in PE | Furthermore, the present study retrospectively investigates whether the transfer of blastocysts on day 5 post-fertilization (D5-ET) may improve the CPR and the LBR in patients with P rise. | January 2012-December 2016 |
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Study Overview
=================
Brief Summary
-----------------
Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.

Detailed Description
-----------------
All consecutive patients with Crohn's disease (CD) who underwent minimally invasive ileocolic resection from 2014 at Mayo Clinic were retrospectively identified using a prospectively maintained institutional database.

Official Title
-----------------
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Conditions
-----------------
Crohn Disease, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease Ileocolic resection Exclusion Criteria: - N/A
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 |
| --- | --- | --- |
| conversion | intraoperative conversion to open (yes/no) | 30-day after surgery | 
| postoperative complications | 30-day postoperative complications described as binary variable (yes/no) and type. | 30-day after surgery | 
| postoperative complications grade | 30-day postoperative complications graded according Clavien-Dindo classification (I-V). | 30-day after surgery | 
| length of hospital stay | length of hospital stay (days) | 30-day after surgery | 
| hospital readmission | 30-day hospital readmission (yes/no) | 30-day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence date | Endoscopic recurrence (date) | 5 years | 
| Recurrence grade | Endoscopic recurrence (Rutgeerts) | 5 years | 
| Recurrence clinical | Clinical recurrence (yes/no) | 5 years | 
| Gastrointestinal Quality of Life Index | quality of life measured according to Gastrointestinal Quality of Life Index (GIQLI) | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crohn disease, minimally invasive surgery, ileocolic resection, outcomes, complication, enhanced recovery after surgery
Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Niaspan™ on Reverse Cholesterol Transport in Healthy Male Subjects

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Niaspan
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Subjects Exclusion Criteria : Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2 | Drug: Niaspan<br>* Niaspan™<br>* Other names: NIASPAN™;Drug: Comparator: Placebo<br>* Placebo<br>|
| Experimental: Arm B<br>Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2 | Drug: Niaspan<br>* Niaspan™<br>* Other names: NIASPAN™;Drug: Comparator: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cholesterol efflux |  | Baseline and 12 weeks | 
| Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C) |  | Baseline and 6 weeks |
Thai Cancer Anemia Survey in Chulalongkorn Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Detailed Description
-----------------
Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemoglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

Official Title
-----------------
Thai Cancer Anemia Survey in Chulalongkorn Hospital

Conditions
-----------------
Anemia, Cancer

Intervention / Treatment
-----------------
* Other: Adult Cancer Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cancer Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>Adult Cancer Patients Tracking anemia management in Adult Cancer Patients | Other: Adult Cancer Patients<br>* Tracking anemia management in Adult Cancer Patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that have anemia during cancer therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic of each patients example treatment duration,type and chemotherapy using, grade of anemia |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Anemia Survey, Chulalongkorn hospital
Acute Effects of LBBP Versus BVP for CRT

Study Overview
=================
Brief Summary
-----------------
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).

Detailed Description
-----------------
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

Official Title
-----------------
Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy

Conditions
-----------------
Heart Failure, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Procedure: left bundle branch pacing
* Procedure: biventricular pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA class II-IV; LVEF <=35%; LBBB with QRS duration >=130ms. Exclusion Criteria: moderate-to-severe aortic stenosis; frequent premature ventricular complexes; signiﬁcant peripheral vascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left bundle branch pacing<br>Left bundle branch pacing | Procedure: left bundle branch pacing<br>* left bundle branch pacing<br>|
| Active Comparator: Biventricular pacing<br>Biventricular pacing | Procedure: biventricular pacing<br>* biventricular pacing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic parameter LV dP/dt(max) | LV dP/dt(max) will be obtained during implant procedure. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical synchrony parameters including QRS duration and QRS area | Acquired from EP system during procedure | 0.5 hour | 
| Mechanical parameters including Ts-SD and IVMD | Acquired by an echocardiologist during procedure | 0.5 hour |