linjc16/ctgov huggingface dataset:
Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed

Official Title
-----------------
Leak After Sleeve Gastrectomy With Positive Intraoperative Indocyanine Green Test: Avoidable Scenario?

Conditions
-----------------
Obesity, Morbid, Diabete Type 2, Cardiac Disease, Vascular Diseases

Intervention / Treatment
-----------------
* Drug: Indocyanine green solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >40 kg/m2 Exclusion Criteria: Non-obese patients

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indocyanine green solution|5 ml of ICG were then injected intravenously to identify the stomach, carefully assessing the angle of His (preoperative written informed consent was obtained from the patient). Adequate perfusion was defined as the direct and clear visualization of the fluorescence around the gastric tube, after an estimated time of 150-180 s followingi.v. administration.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Intraoperative Indocyanine green test | Intraoperative indocyanine green test was performed | from 20 January 2022 to 20 January 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic Sleeve gastrectomy, Bariatric Surgery, Indocyanine greene test, gastric fistula
Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

Study Overview
=================
Brief Summary
-----------------
The goals of this study are to: Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Intramuscular Olanzapine Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have schizophrenia or schizoaffective disorders. Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent. Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry. Female patients must not be pregnant or breast-feeding. Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or schizoaffective disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intramuscular Olanzapine Depot|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.

Detailed Description
-----------------
Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss. The outcomes to be measured in this surgery are operative time, operative complications and blood loss.

Official Title
-----------------
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Conditions
-----------------
Graves Disease, Hyperthyroidism

Intervention / Treatment
-----------------
* Drug: Potassium Iodide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a clinical diagnosis of Graves Disease Patients who have selected surgical resection as treatment of their Graves Disease Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid Exclusion Criteria: Patients deemed unfit for surgery by operating surgeon or anesthesist Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal

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 |
| --- | --- |
| Active Comparator: Potassium Iodide<br>8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. | Drug: Potassium Iodide<br>* 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.<br>* Other names: SSKI;|
| No Intervention: No Treatment<br>The experimental group receives no treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss During Surgery | Blood loss in milliliters during surgery. | up to 162 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graves Disease
CTCs for High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or swelling of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.

Official Title
-----------------
Circulating Tumor Markers for High Grade Glioma

Conditions
-----------------
Stage III and IV Glioma Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma Age 18 or older Signed informed consent Exclusion Criteria:

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 |
| --- | --- | --- |
| to identify and quantify circulating tumor markers |  | 3 years |
VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study to analyze the therapeutic results and clinical evolution all patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive, treated according to the different schemes available, including supportive care or palliative.

Detailed Description
-----------------
Approximately in 6 months, collect and review the retrospective data. During this period, and in order to ensure an excellent quality of the collected data, perform constant monitoring and real-time data received in 2 phases: Monitoring in situ in the focal point: once the information is received before shall enter in the database, will be reviewed each case report data (CRD) for screening for inconsistencies and issue unresolved issues (queries) to sender data center. After entering the information in the database is carry out and resolve those queries that have arisen after consultation Data tables in order to locate inconsistencies or unavailable fields. Telephone Monitoring: data shall be verified through telephone consultations all centers to verify and update recruitment and monitoring patients . To ensure the completion, accuracy and data quality is monitored by telephone at least 30% of registered patients. Final statistical analysis (approximately 8 months from baseline). Publication of results.

Official Title
-----------------
VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years or Not Candidates for Intensive Chemotherapy

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Other: Registry of AML patients > 60 years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy Exclusion Criteria: No exclusion criteria

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 |
| --- |
|Other: Registry of AML patients > 60 years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | The main objective of this study is to retrospectively evaluate the therapeutic results in the LMA in all patients older than 60 years or not candidates for intensive chemotherapy in different stages of the disease, regardless of the treatment received, and even if they do not have received (support or palliative treatment, exclusively | 8 months |
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

Study Overview
=================
Brief Summary
-----------------
A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis.

Official Title
-----------------
A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MK0966; rofecoxib
* Drug: Comparator: naproxen tablet 500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese males or females at least 18 years of age with rheumatoid arthritis

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0966; rofecoxib|nan|
|Drug: Comparator: naproxen tablet 500 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tender joint count |  |  | 
| swollen joint count |  |  | 
| patient's global assessment of disease activity |  |  | 
| investigator's global assessment of disease activity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain assessment |  |  | 
| patient's global assessment of response to therapy |  |  | 
| investigator's global assessment of response to therapy |  |  |
SNP-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants (HSCT)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following HSCT. The study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.

Detailed Description
-----------------
Subjects will be provided with a saliva collection kit which can be used at home. Subjects will return the collection kit in a paid, pre-addressed mailer to the laboratory at Biomodels. The laboratory will isolate and store the DNA located in the cells of the saliva. A portion of this DNA will be used to analyze the different forms of genes. The remainder of the DNA will be destroyed when this study is completed. Biomodels will not be provided with patient identifiers. The investigators will also collect information from medical records, including information about diagnosis, treatment, stem cell transplantation and post-transplantation outcomes. This information will be de-identified.

Official Title
-----------------
Single Nucleotide Polymorphism (SNP)-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants

Conditions
-----------------
Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given informed consent to submit a sample of saliva for DNA isolation and SNP analysis Have undergone autologous HSCT for treatment of Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at the Dana-Farber Cancer Institute from 1/1/2006 through 6/30/2010 Have medical records identifying whether the participants did or did not develop severe mucositis Exclusion Criteria: Received Palifermin (Kepivance) prior to their conditioning regimen

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 |
| --- | --- |
| Mucositis Positive<br>Participants who developed severe mucositis | |
| Mucositis Negative<br>Participants who did not develop severe mucositis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop and validate a clinically applicable SNP-based screening platform for mucositis risk | Develop and validate a clinically applicable SNP-based screening platform that will define mucositis risk among patients undergoing conditioning regimens for HSCT | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem Cell Transplant, Mucositis
COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020

Study Overview
=================
Brief Summary
-----------------
The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.

Detailed Description
-----------------
At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2. As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment. .

Official Title
-----------------
SARS-CoV-2 Seroconversion Study Among GHdC Staff Members

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Serological tests for SARS Cov-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic. Exclusion Criteria: Not be part of the staff of the Grand Hôpital de Charleroi.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serological tests<br>All staff at GHdC who want to know their level of antibodies against SARS CoV-2 | Diagnostic Test: Serological tests for SARS Cov-2<br>* Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological tests to know the level of antibodies against SARS CoV-2 | The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws. | up to 6 weeks |
Study A - MK0767 Monotherapy Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if MK0767 lowers blood glucose after 20 weeks compared to placebo. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

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

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 Diabetes Non-pregnant females and patients who agree not to become pregnant during the study Exclusion Criteria: Patients with Type 1 Diabetes Patients who have been treated with insulin or other antihyperglycemic agents Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Study Overview
=================
Brief Summary
-----------------
The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.

Official Title
-----------------
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

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

Intervention / Treatment
-----------------
* Dietary Supplement: Protein drink
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frail elderly individuals Able to understand and perform the study procedures Exclusion Criteria: Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire) Use of anti-coagulation medication (except of Acetyl Salicyl acid) Renal insufficiency (eGFR <60 mL/min/1.73 m2) Allergic or sensitive for milk proteins

Ages Eligible for Study
-----------------
Minimum 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: Protein drink<br> | Dietary Supplement: Protein drink<br>* Twice a day during 6 months<br>|
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* Twice a day during 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle mass |  | Baseline, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance |  | Baseline, 3 months and 6 months | 
| Blood parameters related to the outcome measures |  | Baseline, 3 months and 6 months | 
| Dietary intake |  | Baseline, 3 months and 6 months | 
| Physical activity |  | Baseline, 3 months and 6 months | 
| Cognitive performance |  | Baseline and 6 months | 
| Blood pressure |  | Baseline, 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcopenia, frail elderly, protein drink, skeletal muscle mass, muscle mass in elderly