linjc16/ctgov huggingface dataset:
Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP)

Study Overview
=================
Brief Summary
-----------------
Combining the advantage of minimally invasive surgery with laparoscopy to reduce postoperative complications and the placement of a retromuscular prosthesis with closure of the defect in order to reduce the risk of adhesion and restore normal anatomy in the treatment of primary and incisional ventral hernias, is made possible through robotic assistance. The challenge of this study concerns the evaluation of quality of life, postoperative pain and recurrence at 6 months in the management of primary and incisional ventral hernias by robot-assisted laparoscopic approach.

Detailed Description
-----------------
The robotic-assisted laparoscopic approach for the treatment of primary and secondary ventral hernias is already used in the visceral department of Nancy in France. This technique seems to reduce post operative pain, to improve quality of live and to reduce recurrence. The goal of the study is to evaluate the benefices of this technique. The quality of life, postoperative pain and recurrence will be evaluated at one and six months postoperatively. The recurrence will be evaluated by clinical examination and a computed tomography scan performed at sixth month postoperatively.

Official Title
-----------------
Feasibility Study of Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP) for the Treatment of Primary and Incisional Ventral Hernia

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: robotic Trans Abdomino Pre Peritoneal prothesis repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major patients undergoing a robotic-assisted laparoscopy procedure for the treatment of ventral hernia repair Exclusion Criteria: patient minor

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: robotic Trans Abdomino Pre Peritoneal prothesis repair|The treatment of primary and incisional ventral hernia using the robotic assisted laparoscopy technique|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at 6 months | Evaluated by clinical examination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Evaluated by a digital scale, from 0 (no pain) to 10 (maximal pain imaginable) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robotic assisted laparoscopy
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Study Overview
=================
Brief Summary
-----------------
The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Official Title
-----------------
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>/=30 kg/m2 routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day willingness and ability to follow the proposed dietary intervention informed consent Exclusion Criteria: previous or planned bariatric surgery in the next 1 year current or planned participation in any structured weight-loss programs in the next 6 months current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids bipolar disorder or attention deficit hyperactivity disorder current use of anti-depressant or anti-psychotic medications eating disorder or any other active disorder that may lead to significant weight changes working night shifts pregnancy or planned pregnancy in the next 1 year uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention<br> | Other: Dietary intervention<br>* Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate |  | Baseline | 
| Retention rate |  | 5 months | 
| Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls | Adherence to the dietary intervention | 2 to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary modification
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.

Official Title
-----------------
Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery

Conditions
-----------------
Hernia, Colorectal Cancer, Gastric Cancer, Inflammatory Bowel Diseases, Gastric Ulcer, Hemorrhoids

Intervention / Treatment
-----------------
* Other: No intervention will be given to patients.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery. Must be willing and able to provide informed consent. Exclusion Criteria: Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer or gastric cancer patient<br>Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach. | Other: No intervention will be given to patients.<br>* Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.<br>|
| Non-malignant disease patient<br>Patients suffering from non-malignant disease scheduled to have surgery. | Other: No intervention will be given to patients.<br>* Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of diagnosis by pathologist | Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used. | Up to 3 years |
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Study Overview
=================
Brief Summary
-----------------
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Detailed Description
-----------------
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.

Official Title
-----------------
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive. Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting. Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021. Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions. Exclusion Criteria: Incomplete medical history

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Pyrotinib Plus Vinorelbine<br>lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) | |
| Lapatinib Plus Capecitabine<br>pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyrotinib, Lapatinib, Vinorelbine
Hemoglobin Measured by Orsense NBM-200MP Device and Laboratory Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the hemoglobin results obtained with the Orsense NBM-200MP device and the Clinical Laboratory.

Official Title
-----------------
Comparison of the Hemoglobin Results Obtained With the Orsense NBM-200MP Device and the Clinical Laboratory

Conditions
-----------------
Emergency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: emergency unit patients requiring an hemoglobin determination 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 |
| --- | --- |
| hemoglobin determination<br>emergency unit patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin measurement using the Orsense NBM-200MP device |  | 4 months |
Removal of Massive Subretinal Organized Blood Clot With Fragmatome

Study Overview
=================
Brief Summary
-----------------
By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily.

Official Title
-----------------
Removal of Massive Subretinal Organized Blood Clot With Fragmatome

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: fragmatome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with massive subretinal hemorrhage from age related macular degeneration Patients had organized subretinal blood clot were managed by inferior retinectomy. Exclusion Criteria: Patients without massive subretinal hemorrhage Patients were not age related macular degeneration.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fragmatome|Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | visual acuity change in logMAR in different time point | Before operation, 1 weeks after operation, 1 month after operation. | 
| spherical equivalent | spherical power + half of cylinder power | Before operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organized blood clot, fragmatome, exudative age related macular denegeration
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).

Official Title
-----------------
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Device: hand-held swept source optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system - Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe - Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center Exclusion Criteria: - Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study - Pilot (ER): hemodynamically unstable, unable to consent - Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging patients<br>Get uveitis patients and ER patients to image their eyes | Device: hand-held swept source optical coherence tomography<br>* images the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance | By the ability to detect cells in the eye compared to clinical exam | Up to 18 months |
Maternal Vitamin D Status and Neonatal Bone Strength

Study Overview
=================
Brief Summary
-----------------
Objectives: To determine the incidence of vitamin D deficiency among Israeli pregnant women To access whether maternal vitamin D status affects infant bone strength. Methods: Vitamin D levels -in cord blood and maternal blood The mother will fill a demographic and nutritional questionnaire The Infants: Growth assessment of the infants: weight length and head circumference Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)

Official Title
-----------------
Maternal Vitamin D Status and Neonatal Bone Strength

Conditions
-----------------
Maternal Vitamin D Status, Neonatal Bone Quantitative Ultrasound Measurements

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mother-baby pairs, birth week 35-42. Jewish and Arab women that read and understand Hebrew. Exclusion Criteria: large neonatal congenital defects.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mother infants pairs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone speed of sound and maternal vitamin D levels |  | first tow days of life |
A Study to Assess Thymic Function Using PET/CT and MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a positron emission tomography/computed tomography (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan and a MRI before and after the participants transplantation.

Official Title
-----------------
An Initial Study of FDG-PET/CT and MRI to Assess Thymic Function

Conditions
-----------------
CD34 Selected Peripheral Blood Stem Cell Graft

Intervention / Treatment
-----------------
* Device: PET/CT scans
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's age is ≥18 or ≤65 years old. Patients must have a plan to receive a CD34-selected peripheral blood stem cell graft. Exclusion Criteria: Patient is not able to undergo MR imaging due to any contraindication to MRI based on departmental MR questionnaire (e.g. past gadolinium allergies, failure of metallic screening, claustrophobia, inability to lay flat for duration of the study, inability to hold breath, etc.) Pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PET/CT scans and MRI<br>Eligible patients will be enrolled onto the study, and will undergo 3 limited field of view (FOV) FDG-PET/CT scans and MRI of the chest: at baseline (within 4 weeks prior to transplantation), and approximately 3 months (+/-2 weeks) and 6 months (+/-2 weeks) after transplant. PET/CT and MR imaging can be completed on the same day. We will also offer the exams on other days if this is easier for the patient. The PET/CT and MR should be performed within 2 weeks of each other. | Device: PET/CT scans<br> <br> Device: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in thymic size | A clinically meaningful change is defined as increase in thymic size (> 0.2cm increase in uni-dimensional diameter), functional volume (>10%) or uptake (≥25%). We will report proportion of patients with each component of clinically meaningful change, as well as the proportion with at least one component, along 95% exact confidence intervals. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, MRI, Assess Thymic Function, 16-1244
The Effects of Sports Drinks on Urinary Lithogenicity

Study Overview
=================
Brief Summary
-----------------
The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.

Detailed Description
-----------------
Participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. Urine collections will be performed during both periods. Diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.

Official Title
-----------------
The Effects of Sports Drinks on Urinary Lithogenicity

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Drug: Gatorade
* Drug: Performance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years old men and women able to sign informed consent Exclusion Criteria: history of kidney stones bone disease parathyroid disease

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gatorade|nan|
|Drug: Performance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary supersaturation of calcium oxalate |  |  | 
| Urinary citrate excretion |  |  | 
| Urinary calcium excretion |  |  | 
| Urinary sodium excretion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
citrate, nephrolithiasis, oxalate