linjc16/ctgov huggingface dataset:
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)

Conditions
-----------------
Proliferative Vitreoretinopathy

Intervention / Treatment
-----------------
* Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with rhegmatogenous retinal detachment complicated by PVR grade C Exclusion Criteria: History of pars plana vitrectomy for PVR grade C History of silicone oil injection History of ocular trauma Diabetic retinopathy Glaucoma Giant retinal tear

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU<br> <br> |
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal reattachment rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVR recurrence, |  |  | 
| macular pucker, |  |  | 
| reoperation, |  |  | 
| ocular hypotony, |  |  | 
| visual acuity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PVR, Oral colchicine, Dexamethasone, low molecular weight heparin, 5-FU
TOADS Study: TO Assess Death From Septic Shock.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .

Detailed Description
-----------------
The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.

Official Title
-----------------
Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Other: epidemiologic study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Died of septic shock in the intensive care unit (ICU) At least 6 hours of vasopressors Exclusion Criteria: Legally protected adult patient. Less than 6 hours of vasopressors Opposition to participation in the study expressed by the patient, family or person of trust

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: epidemiologic study|There is no intervention as it is a pure observational study for epidemiologic survey.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire. | Recording of the context and the cause of death with a questionnaire | Patients will be followed during their hospital stay, with a maximal follow up of 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mortality
Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes

Study Overview
=================
Brief Summary
-----------------
Racial and ethnic minorities with type II diabetes in the US are more likely to develop complications and die from the disease than the general population. The foreign-born subset of this population is less likely to adhere to diabetes care recommendations than US-born patients, thereby placing them at higher risk for complications. In our previous pilot project, eight stories were assessed through preliminary multi-site intervention for acceptability and efficacy in diabetes management among Latino and Somali patients with poorly controlled type II diabetes. The goal of this project is to evaluate a new format for delivery of a culturally tailored digital storytelling intervention by incorporating a facilitated group discussion following the videos, for management of type II diabetes in Latino communities.

Official Title
-----------------
Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Reduction of Diabetes-Related Health Disparities

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Self-efficacy for diabetes management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Self-identify as Hispanic/Latino Are Spanish-speaking Receive primary care at one of the participating clinical sites Self-reported diagnosis of type II diabetes Exclusion criteria: Not able to give informed consent Not able to participate in a group discussion

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Study has one arm - who will all receive the intervention | Other: Self-efficacy for diabetes management<br>* Participants at both sites will watch a 12 minute video featuring the digital stories on diabetes. Following the video, participants will engage in a brief facilitated discussion regarding motivations and barriers to diabetes management, led by a trained Spanish-speaking facilitator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for diabetes management | The evaluation will assess the degree to which the intervention motivates the patient to improve self-management of diabetes. The evaluation will also assess overall acceptability. Items for this survey were adapted from a well validated health communication assessment tool produced by the National Cancer Institute. | Assessment will be done immediately after participants watch the intervention video |
Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
The incretin hormones are secreted from the gastrointestinal tract in response to nutrient ingestion, and are responsible for 70 % of insulin secretion in response to glucose. The incretin response is attenuated in subjects with type 2 diabetes and other conditions associated with insulin resistance. Polycystic ovary syndrome (PCOS) is characterised by irregular periods and increased androgen levels. It is the most common endocrine disorder amongst young women at fertile age, and the most common cause of female infertility. Insulin resistance plays an important role in the development of the disease, and women with PCOS are at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously been investigated in women with PCOS, and the purpose of the present study was to investigate the secretion of the two most important incretin hormones Glucose-like peptide-1 (GLP-1) and Glucose dependent insulinotropic peptide (GIP) during a three hour oral glucose tolerance test.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who fulfill the Rotterdam criteria for PCOS. Age 18-38 Exclusion Criteria: Other endocrine diseases or diseases known to influence glucose/insulin/fat metabolism Oral contraceptive administration within three months of study start

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Basic Science


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: metformin<br>* 1000 mg metformin x 2 daily during 8 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Accuracy of Pulse Oximeter With Profound Hypoxia

Study Overview
=================
Brief Summary
-----------------
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.

Official Title
-----------------
Accuracy of Pulse Oximeter With Profound Hypoxia

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

Intervention / Treatment
-----------------
* Device: ANNE Limb Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is male or female, between the ages of 18 and 55 years. The subject is in good general health with no evidence of any medical problems The subject is fluent in both written and spoken English The subject has provided informed consent and is willing to comply with the study procedures. Exclusion Criteria: Known history of heart disease, lung disease, kidney or liver disease Diagnosis of asthma, sleep apnea, or use of CPAP Subject has diabetes Subject has a clotting disorder The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation The subject has any other serious systemic illness Th subject is a current smoker Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly The subject has a history of fainting or vasovagal response The subject has a history of sensitivity to local anesthesia The subject has a diagnosis of Raynaud's disease The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test) The subject is pregnant, lactating, or trying to get pregnant The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis<br> | Device: ANNE Limb Sensor<br>* Pulse Oximeter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARMS of SpO2 Measurements with ANNE Limb compared to SaO2 | Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2) | 1 hour |
Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing.

Official Title
-----------------
Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients

Conditions
-----------------
Indications for a Total Hip Prosthesis

Intervention / Treatment
-----------------
* Device: ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total hip replacement Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional result |  |  | 
| Speed of rehabilitation |  |  |
Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.

Official Title
-----------------
Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Conditions
-----------------
ARDS

Intervention / Treatment
-----------------
* Drug: Mesenchymal stem cells
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS diagnosed using Berlin definition Eligible patients were at least 18 years of age had acute onset of ARDS. Bilateral opacities in chest radiography No cardiac failure PaO2/FiO2 ratio < 200 Exclusion Criteria: 72 hours after all inclusion criteria met Pre-existing severe diseases of any major organs Pregnancy Pulmonary hypertension Malignant diseases HIV infections.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell arm<br>Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment. | Drug: Mesenchymal stem cells<br> <br> |
| Placebo Comparator: Placebo<br>Patients received one dose of normal saline. | Drug: Placebo<br> <br> * Other names: Intravenous saline infusion will be designated as placebo.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the adverse events between mesenchymal stem cell treatment and placebo groups |  | From day 0 at the start of treatment to day 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital indices by treatment group | Days in hospital ICU free days at day 28 Ventilator free days at day 28 | From admission to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, mesenchymal stem cells, Safety, Cytokines
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets

Study Overview
=================
Brief Summary
-----------------
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Detailed Description
-----------------
Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.

Official Title
-----------------
Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA

Conditions
-----------------
Tooth Demineralization

Intervention / Treatment
-----------------
* Other: Silver nanoparticles
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidates for orthodontic treatment. Exclusion Criteria: Patients with O.D 11 and / or 21 absent. Patients who present dentures of any kind in OD 11 and 21. Patients presenting endodontic OD 11 and 21. Patients presenting data gingivitis day cementing brackets.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 35 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver nanoparticles<br>Half of the mouth was applied silver nanoparticles. Allocation was randomized. | Other: Silver nanoparticles<br>* Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.<br>|
| Experimental: Placebo<br>Half of the mouth was applied placebo. Allocation was randomized. | Other: Placebo<br>* Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.<br>* Other names: Primer-bond;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enamel demineralization (Diagnodent - pen evaluation) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silver nanoparticles, demineralization, brackets
HLA Matching - Unrelated Umbilical Cord Blood Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord blood (UCB) transplantation and to identify the level of HLA matching required assuring successful outcome of unrelated UCB transplantation.

Detailed Description
-----------------
The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord blood (UCB) transplantation and to identify the level of HLA matching required assuring successful outcome of unrelated UCB transplantation. The study will answer the following questions: Is HLA matching beneficial to unrelated UCB transplantation? Which HLA loci, HLA-A, B, C, DRB1, or BQB1 is/are important to math, or alternatively to mismatch, to improve graft survival? Which HLA loci, HLA-A, B, C, DRB1, or BQB1 mismatches is/are permissive mismatches or well tolerated mismatches? What level of typing resolution (low, intermediate, or hgh) is required to perform patient/donor H:A matching? By studying the cells and blood of donors and recipients, we may learn more about improving the tissue matching between unrelated donors and their recipients. Also, we hope to learn if an additional level of matching testing improves the results of the transplant treatment. Increasing knowledge about tissue matching could result in the improved long-term survival of cord blood transplant recipients.

Official Title
-----------------
Impact of HLA Matching on Outcome in Pediatric Patients Undergoing Unrelated Umbilical Cord Blood Transplantation.

Conditions
-----------------
Hematologic Diseases

Intervention / Treatment
-----------------
* Procedure: HLA typing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric Patients undergoing an unrelated umbilical cord blood transplantation. Exclusion Criteria: Refusal to participate in study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: HLA typing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |