linjc16/ctgov huggingface dataset:
Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.

Official Title
-----------------
Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Conditions
-----------------
Acute Compartment Syndrome

Intervention / Treatment
-----------------
* Behavioral: Muscle contraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old no current extremity injuries willing to provide written informed consent Exclusion Criteria: history of any anatomy-altering surgery to the extremity in question history of peripheral vascular disease history of pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exercise<br>NIRS values of all participants will be measured at baseline and following each 30-60 second exercise. | Behavioral: Muscle contraction<br>* Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near infrared spectroscopy | NIRS values will be measured before and after muscle fatigue | <30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
near-infrared spectroscopy
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of CO2 insufflations during ERCP Primary objective: To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group. Secondary objective: Endoscopist: To assess the adequacy of bowel distension for adequate luminal visualization To assess the peristaltic movement during the ERCP Anesthetist: To measure the PCO2 level in patient post procedure. To assess the amount of sedation required during the procedure. To assess saturation and vital signs through out the procedure. To assess requirement of buscopan.

Detailed Description
-----------------
mentioned in complete

Official Title
-----------------
A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).

Conditions
-----------------
Obstructive Jaundice

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive adult patients referred for ERCP to AIG Hyderabad Exclusion Criteria: Age < 18 years old excluded from the study. Patients with COPD. Patients with poor ejection fractions and decompensated heart failure. Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments. Patients with recent endoscopic procedure within 24 hours. Patient with history of recent surgery within 7 days of duration. Pregnant patients. Patients not keen to give consent for the study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group-A, use of air;<br> | |
| Group-B use of CO2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort post ERCP | the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale ) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal distention prior and post ERCP | The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon dioxide insufflation
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

Detailed Description
-----------------
Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points. Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.

Official Title
-----------------
Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Imatinib mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CML Ph+ (assessed by cytogenetic or FISH) Age ≥ 18 year at inclusion PS grade 0 to 2 (ECOG) previous allogeneic stem cell transplantation molecular, cytogenetic or haematological relapse in chronic phase after transplantation Immune therapy for graft versus host disease stopped within 2 months from inclusion Adequate and organ function, defined as the following: total bilirubin <3x uln, sgpt <3x uln, creatinine <2x uln. informed consent sign up Exclusion Criteria: Age less than 18 y accelerated or blastic phase previous therapy with imatinib active malignancy other than CML or non-melanoma cancer of the skin current treatment with another investigational agent

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imatinib mesylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - to assess the tolerability of Imatinib given at a daily dose of 400mg |  |  | 
| - to evaluate the hematologic, cytogenetic and molecular responses at various check points. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - to assess donor/recipient chimerism during Imatinib therapy |  |  | 
| - to evaluate the survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CML, Imatinib mesylate, Stem cell transplantation
Male Stress Urinary Incontinence and Sexual Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.

Official Title
-----------------
Male Stress Urinary Incontinence and Sexual Health

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Artificial urinary sphincter
* Device: InVance Sling
* Device: AdVance Sling
* Device: Virtue Sling
* Drug: Contigen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence. Exclusion Criteria: Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia. They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Artificial urinary sphincter|Standard of care|
|Device: InVance Sling|Standard of care|
|Device: AdVance Sling|Standard of care|
|Device: Virtue Sling|Standard of care|
|Drug: Contigen|2.5-10 cc|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire |  | 1 year | 
| Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health |  | 1 year |
Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .

Official Title
-----------------
Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AECC definition of acute respiratory distress syndrome Early acute respiratory distress syndrome (within 72 h of diagnosis) PF ratio < 200 at PEEP ≥ 8 cmH2O Exclusion Criteria: Imminent death Contraindication to corticosteroid treatment Already on more than 0.5 mg/kg of methylprednisolone or its equivalent Evidence of uncontrolled infection Refusal of managing physician to participate in the study

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 |
| --- | --- | --- |
Effect of Prematurity on Renal Function in 5 Years Old Children

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To evaluate the effect of prematurity on renal function in 5 years old children To compare former premature children treated by ibuprofen in the neonatal period to controls

Official Title
-----------------
Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls

Conditions
-----------------
Prematurity of Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191) Exclusion Criteria: lack of parental consent

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>former premature children treated by ibuprofen | |
| 2<br>former premature children not treated by ibuprofen | |
| 3<br>former term children (control) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance |  | 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  | at 3 years of age | 
| Blood Pressure |  | 5 years of age | 
| Hemodynamic tolerance to mild exercise |  | 3 years of age | 
| Growth |  | 4 years of age | 
| Growth |  | 5 years of age | 
| Hemodynamic tolerance to mild exercise |  | 4 years of age | 
| Hemodynamic tolerance to mild exercise |  | 5 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature renal function, ibuprofen, blood pressure, Renal function
Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.

Study Overview
=================
Brief Summary
-----------------
The timeliness of routine childhood immunization should be an important component in measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is overlooked. This study will determine the age- specific immunization timely uptake rates for the various vaccines covered in the routine childhood immunization and seek out factors that affect timely vaccine uptake among Nigerian children.

Detailed Description
-----------------
This study will determine the extent of timely and complete routine childhood vaccination uptake in Nigeria. The investigators will also seek to understand the factors that influence timely/complete uptake and make recommendations. this study will also determine if the present immunization records system in Nigeria is capable of measuring timely immunization uptake.

Official Title
-----------------
Fully Vaccinated Yet Under-vaccinated: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria

Conditions
-----------------
Vaccination Failure

Intervention / Treatment
-----------------
* Behavioral: Adherence to timely vaccine uptake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received all vaccines Available immunization records Exclusion Criteria: Did not receive all vaccines Non- available immunization records

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 24 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Adherence to timely vaccine uptake | Behavioral: Adherence to timely vaccine uptake<br>* Adherence to timely vaccine uptake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age specific timely vaccination rate for all vaccines in routine vaccination schedule | The primary outcome measure, age- appropriate immunization is defined as receipt of a scheduled vaccine dose within 30 days of the recommended age. Timeliness will be calculated using child health card data as at 31st December 2018. Descriptive statistics will be produced to describe the characteristics of the sample using frequencies and proportions. Descriptive outcome measures for each dose will be coded as either 'no delay'- age appropriately immunized, delay of 1-6 months' , 'delay greater than 6 months', vaccine received 'acceptably early' (within 30 days prior to when it was due), vaccines received 'too early' (within 30 days prior to when it was due) or vaccine dose not recorded. | 24 months |
Comparing Visual Acuity Measurements (How Well You Can See) Using a Standard ETDRS Chart & a Handheld ETDRS Chart

Study Overview
=================
Brief Summary
-----------------
Comparing visual acuity measurements (measurements of how well you can see) using a standard ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart

Detailed Description
-----------------
Prospective determination of agreement between standard ETDRS chart and handheld illuminated ETDRS equivalent chart in eyes with retinal pathology

Official Title
-----------------
Prospective Determination of Agreement Between Standard ETDRS (Early Treatment Diabetic Retinopathy Study) Chart and Handheld Illuminated ETDRS Equivalent Chart in Eyes With Retinal Pathology

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study (one visit per patient). Age greater than 18 years. Clinical diagnosis of retinal disease (including age-related macular degeneration, macular degeneration, retinal vessel occlusion, among others). Exclusion Criteria: Presence of a significant cataract as determined by your doctor. Presence of a significant posterior capsular opacity (haziness in your eyes) as determined by your doctor. Diagnosis of uveitis (inflammation in part of the eye).

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 |
| --- | --- | --- |
| ETDRS Letter Score | To determine the visual acuity measurement using this handheld internally illuminated ETDRS chart, and a standard back illuminated EDTRS chart. This will be done during the visual acuity test. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS Letter Score Consistency | To use the score results to determine whether this new, handheld chart, called the RAM-ETDRS chart, is just as efficient as the standard ETDRS eye chart in measuring your vision. This will be done during your visual acuity exam. | 1 Day |
F-18-OMFD-PET for Radiotherapy Treatment Planning and Evaluation of Early Therapy Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the amino acid uptake of brain tumors, before and during radiotherapy, with positron emission tomography.

Official Title
-----------------
F-18-OMFD-PET for Radiotherapy Treatment Planning and Evaluation of Early Therapy Response

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brain tumor Radiation therapy indicated Written consent Exclusion Criteria: Pregnancy Mental impairment Drug/alcohol abuse

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, F-18-OMFD