linjc16/ctgov huggingface dataset:
Challenges of Hip Fracture Care in Developing Countries. Experience at a Level 3 Center in Panama

Study Overview
=================
Brief Summary
-----------------
An observational study using the information records at the Hospital Regional Rafael Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early treatments results of hip fracture patients treated in this institution.

Detailed Description
-----------------
Hip fractures are a major public health concern due to increasing ageing of the population, rising costs and associated morbidity and mortality. The problem is more serious in developing countries, because of limited economic and technical resources available. The aim of the following study is to analyze the epidemiology and early treatment results of hip fracture patients treated in our unit. This study will be done at the Hospital Rafael Hernandez Regional Hospital, a third level facility located in the province of Chiriqui, Republic of Panama. It is a retrospective observational study. For this the study will use the hospital records, including imaging studies were reviewed, including the Singh Index, and all relevant data will be analyzed with SPSS 21 software.

Official Title
-----------------
Hip Fracture Epidemiology at Hospital Regional Rafael Hernandez. September 2014 to March 2015.

Conditions
-----------------
Hip Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hip fractures Exclusion Criteria: All other fractures and no recorded survey

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 |
| --- | --- |
| hip fracture<br>fracture of proximal femur | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical classified action of the Fracture | kind of proximal femoral fracture as sub trochanteric, intertrochanteric or subcapital | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex | male or female | 6 months | 
| Age | years old of the patient when he or she has the fracture | 6 months | 
| Comorbidities | Diseases of the patient (diabetes, hight blood pressure, others) | 6 months | 
| Energy of Trauma | IF it was high energy or low energy trauma | 6 months | 
| Average length of stay | Time frame that the patient stayed at the hospital | 6 months | 
| Osteoporosis | Severe, mild, light | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, trochanteric fracure, subtrocantheric fracture, femoral head fracture, epidemiology
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

Study Overview
=================
Brief Summary
-----------------
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to. This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.

Official Title
-----------------
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Type1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: AID System
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year Have a body mass index of 18.5 to 35 kilogram per meter squared Have a hemoglobin A1c level ≥6.0% and ≤9.0% Exclusion Criteria: Have known allergies or history of hypersensitivity to insulin lispro Have had an episode of severe hypoglycemia within the past 6 months Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AID System Containing Insulin Lispro<br>The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. | Device: AID System<br>* AID system<br>* Other names: LY8888AU;Drug: Insulin Lispro<br>* Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.<br>* Other names: LY275585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges |  | Up to 4 hours post challenge | 
| Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge |  | Up to 4 hours post challenge | 
| Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity |  | Up to 4 hours post challenge |
Study Evaluating Prevenar Vaccine in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.

Official Title
-----------------
An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: Prevenar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female children 2 months of age (42 to 100 days) in good health. An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study. Infants whose parent(s)/guardian(s) will be available for the entire study period. Exclusion Criteria: Hypersensitivity to any component of the vaccine, including diphtheria toxoid Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy. Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 100 Days

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Prevenar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Infants, Vaccine
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique

Study Overview
=================
Brief Summary
-----------------
The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.

Official Title
-----------------
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)

Conditions
-----------------
Cesarean Scar Niche

Intervention / Treatment
-----------------
* Procedure: Conventional
* Procedure: Modified


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnant Intended elective cesarean section Exclusion Criteria: Cervical dilatation of more than 4 cm Previous cesarean section

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional technique<br>Closure of the uterotomy with a conventional two-layer technique | Procedure: Conventional<br>* Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer.<br>|
| Experimental: Modified technique<br>Closure of the uterotomy with a modified two-layer technique | Procedure: Modified<br>* The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a cesarean scar niche more than 2 mm deep. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual myometrial thickness of the cesarean scar (RMT) |  | 6 months | 
| Cesarean scar niche depth, width, length, myometrium adjacent to the scar |  | 6 months | 
| Post-menstrual spotting |  | 15 months | 
| Incidence of cesarean scar pregnancy or spontaneous abortions |  | 72 months | 
| Adverse pregnancy outcomes in the following pregnancy | Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence | 72 months |
Problem Solving/Physical Interventions and Aging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style.

Detailed Description
-----------------
The study recruited 273 participants from a community-based HMO for whom computerized health service utilization and cost data were already available, as well as cognitive, functional, and health status measures. The participants were randomly placed into one of four treatment groups: exercise, health promotion, combination exercise and health promotion, and routine medical care. Assessments for physical performance, emotional well-being, and physical and emotional health status were conducted at screening, baseline, after 3 months (post-treatment), and at 6, 12, and 18-month follow-up by interviewers blind to treatment assignment.

Official Title
-----------------
Problem Solving/Physical Interventions and Aging

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Behavioral: exercise
* Behavioral: health promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 70 or older live independently less than 150 minutes regular exercise per week able to walk across a room without a person assisting English speaking planning to stay in local area for at least 6 months (duration of active study) Exclusion Criteria: cancer heart attack stroke uncontrolled arrhythmia uncontrolled hypertension uncontrolled diabetes surgery during the past year ongoing mental health or psychiatric condition

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|
|Behavioral: health promotion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical health and function |  | screening, baseline, 3, 6, 12, and 18 months | 
| affective status |  | screening, baseline, 3, 6, 12, and 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, health promotion, independent living, affective aspects
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).

Official Title
-----------------
Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age. BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100). Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal. Exclusion Criteria: Complete ankylosis (fusion) of spine. Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors. Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP. |  |  |
Mean Arterial Pressure (MAP) and Renal Perfusion: Evaluation of Critically Ill Patients With Normal Creatinine or Reduced Renal Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the renal perfusion depending on the MAP.

Official Title
-----------------
MAP and Renal Perfusion: Evaluation of Critically Ill Patients With Normal Creatinine or Reduced Renal Function

Conditions
-----------------
Kidney Failure, Acute

Intervention / Treatment
-----------------
* Procedure: controlling the MAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Intensive care patient Treated with vasopressor Given informed consent Arterial infusion A bladder catheter Exclusion Criteria: Anamneses of hypertension Neurological trauma Acute renal insufficiency other than prerenal or acute tubular necrosis etiology Hepatorenal syndrome Treated with diuretics Mechanical ventilation and unstable

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: controlling the MAP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatinine clearance after 4 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resistance index |  |  | 
| diuresis |  |  | 
| urinary indices of renal function |  |  |
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

Official Title
-----------------
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.

Conditions
-----------------
Colorectal Neoplasms, Liver Neoplasms

Intervention / Treatment
-----------------
* Drug: Irinotecan + 5 FU + folinic acid
* Drug: Folinic Acid + 5 FU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour. Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion. Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases. Exclusion Criteria: Prior hepatic radiation or resection. Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es). Prior chemotherapy for metastatic disease.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Irinotecan + 5 FU + folinic acid<br>* irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: Folinic Acid + 5 FU<br>* folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival (DFS) | time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. | last tumor assessment date or cut-off date, whichever is earlier. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rates | Probability of being alive was calculated in a yearly increment. | Median follow-up time (42 months) |