linjc16/ctgov huggingface dataset:
Ventricular Pace Suppression Study

Study Overview
=================
Brief Summary
-----------------
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Detailed Description
-----------------
The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Official Title
-----------------
Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker

Conditions
-----------------
Pacemaker Indication

Intervention / Treatment
-----------------
* Device: VpS algorithm in EVIA and ENTOVIS pacemakers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paroxysmal AV block and/or Sinus Node Dysfunction DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability Exclusion Criteria: Permanent AV block III° Permanent Atrial Fibrillation/ Flutter Require mode other than DDD(R)-ADI(R) or DDD(R) Have a life expectancy of less than six months Expected to receive heart surgery within six months Enrolled in another cardiac investigation
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ventricular Pace Suppression- ON<br> | Device: VpS algorithm in EVIA and ENTOVIS pacemakers<br>* For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.<br>|
| Other: Ventricular Pace Suppression- OFF<br> | Device: VpS algorithm in EVIA and ENTOVIS pacemakers<br>* For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. |  | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. |  | 6-8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventricular pace suppression, pacemaker, efficacy, safety, support of intrinsic heart rhythm
Expanded Access to Velmanase Alfa

Study Overview
=================
Brief Summary
-----------------
Individual patient expanded access requests may be considered for patients who have no other treatment options.

Detailed Description
-----------------
Expanded access may provide access for treatment prior to approval by the local regulatory agency.

Conditions
-----------------
Alpha-Mannosidosis

Intervention / Treatment
-----------------
* Drug: Velmanase Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Velmanase Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pulse Oximeter Motion Study

Study Overview
=================
Brief Summary
-----------------
Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.

Detailed Description
-----------------
Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples

Official Title
-----------------
Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Other: Motion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult English speaking - Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motion<br>Right hand performs three different motion types | Other: Motion<br>* Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse oximetry reading |  | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood gas |  | immediate |
Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.

Detailed Description
-----------------
This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.

Official Title
-----------------
MERGE: MulticEnter ReGistry With Eeva

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: In-vitro fertilization using Eeva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. Exclusion Criteria: history of cancer. gestational carrier.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-vitro fertilization using Eeva<br>Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle. | Device: In-vitro fertilization using Eeva<br>* Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up | 5-6 gestational weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
Preventing Esophageal Stent Migration in Esophageal Strictures

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.

Official Title
-----------------
Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures

Conditions
-----------------
Stent Migration

Intervention / Treatment
-----------------
* Device: OTSC Stentfix
* Procedure: Stent Suturing / Endoscopic Clips


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH. The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form. Willing to comply with all study procedures and be available for the duration of the study. English and Non-English speaking participants. Exclusion Criteria: 1. Patients who have strictures treated with luman apposing stents.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No fixation<br> | |
| Active Comparator: Stent Suturing<br> | Procedure: Stent Suturing / Endoscopic Clips<br>* Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.<br>|
| Experimental: OTSC Stentfix<br> | Device: OTSC Stentfix<br>* Stent placement with fixation of the esophageal stent using OTSC Stentfix.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Experience Stent Migration |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedural Time | Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation. | 120 minutes | 
| Change in Score on Dysphagia Outcome and Severity Scale (DOSS) | DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia. The total range of score is 1-7; a lower score indicates more severe symptoms of dysphagia. | Baseline, Week 48 |
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.

Official Title
-----------------
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: Capecitabine
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rectal adenocarcinoma Clinical staged T3/4 or any node-positive disease Age of 18-75 years Karnofsky Performance Status > 80 Adequate bone marrow reserve, renal and hepatic functions Without previous antitumoural chemotherapy No evidence of metastatic disease Written informed consent before randomization UGT1A1's genotype of 6/6 or 6/7 Exclusion Criteria: Clinical staged I or IV Age of <18 or >75 years Karnofsky Performance Status < 80 Previous pelvis radiotherapy Previous antitumoural chemotherapy Clinically significant internal disease Refuse to write informed consent before randomization UGT1A1's genotype of 7/7

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: Irinotecan<br>irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week | Drug: Irinotecan<br>* initial from 50mg/m2/week and increased by 15mg/m2/week<br>Drug: Capecitabine<br>* 625mg/m2,bid,d1-5,qw<br>* Other names: Xeloda;Radiation: Radiotherapy<br>* 50Gy for whole pelvis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity | Grade 4 hemato-toxicity Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity) | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response (pCR) |  | within 14days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
A Study of Meditation as a Treatment for Epilepsy

Study Overview
=================
Brief Summary
-----------------
Epileptic seizures may occur at times of stress and commonly increase life stress. This study will evaluate whether meditation improves seizure control and quality of life for individuals with uncontrolled epilepsy.

Detailed Description
-----------------
Individuals who have uncontrolled epilepsy commonly experience disability, depression, anxiety and injuries from seizures. For such individuals, ideal treatments should improve quality of life through control of seizures and improved emotional state. Meditation with cultivation of emotional balance is known to improve emotional state and may also benefit seizure control in some individuals. In this study, individuals with uncontrolled epilepsy will receive detailed training in meditation to determine whether the training leads to improvements in seizure control and various measures of emotion and quality of life.

Official Title
-----------------
Treatment of Epilepsy by Meditation and Cultivation of Emotional Balance

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Behavioral: Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 or more seizures per month ability to participate in meditation

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: Meditation<br> | Behavioral: Meditation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency |  | 20 weeks | 
| Quality of Life |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  | 20 weeks | 
| Affect |  | 20 weeks | 
| Anxiety |  | 20 weeks | 
| Sleep quality |  | 20 weeks |
Parenteral Nutrition Support for Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Detailed Description
-----------------
To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Official Title
-----------------
Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.

Conditions
-----------------
Cancer Cachexia, Pancreatic Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: parenteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological proved pancreatic cancer progressive cancer cachexia refractive to enteral supplementation informed consent Exclusion Criteria: prefinal status septic 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parenteral nutrition<br>25kcal/kg/bw /day via parenteral support | Dietary Supplement: parenteral nutrition<br>* 25kcal/kg bw with parenteral nutrition<br>* Other names: no specific brand name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional status presented by phase angle |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity of port infections, quantity of oedema, quantity of diarrhea |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parenteral nutrition, cancer cachexia, pancreatic cancer
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Detailed Description
-----------------
A cohort study on 500 patients with type 2 diabetes without known heart disease and age > 50 years of age. On inclusion and on yearly basis, patients are evaluated by echocardiography, ECG, blood tests to examine NT-ProBNP, hs-CRP, troponin, kidney function and 6 minutes hall walk test.

Official Title
-----------------
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes

Conditions
-----------------
Chronic Heart Failure, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes age > 50 years Exclusion Criteria: History of acute or chronic heart failure History of ischemic heart disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Chronic Heart Failure | Determined by echocardiography according to European Society of Cardiology (ESC) definitions | During 5 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-ProBNP | Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP) | During 5 year follow up | 
| hs-CRP | Change in High-sensitivity C-reactive protein (hs-CRP) | During 5 year follow up | 
| Troponin | Change in Troponin | During 5 year follow up | 
| 6 minutes walk test | Change in 6 minutes walk test | During 5 year follow up |
Evaluation of Sarcopenia in Elderly at the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital. The main questions it aims to answer are; What is the frequency of sarcopenia in elderly patients at emergency department? Is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?

Official Title
-----------------
Frequency of Sarcopenia and Relation With Mortality in Elderly at the Emergency Department

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above the age of 65 admitted to the emergency department Able to walk without support No lower extremity fracture No disease with neuromuscular involvement Exclusion Criteria: In the presence of a cerebrovascular event Those in need of critical intervention when applying to the emergency department Unconscious patients

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 0-28 days |