linjc16/ctgov huggingface dataset:
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
This study explored the pattern and type of amputations performed on patients with diabetic foot who were admitted to our institution, as well as the 7-year mortality rate of patients with diabetic foot at the same institution. We believe that our study makes a significant contribution to the literature because it highlights the need for strengthening efforts to decrease the risk of amputation and mortality among patients with diabetic foot, especially in Jeddah, Saudi Arabia.

Official Title
-----------------
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study

Conditions
-----------------
Diabetic Foot, Amputation

Intervention / Treatment
-----------------
* Other: NO intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From the medical records of King Abdulaziz University Hospital (KAUH). Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: NO intervention|N/: NO intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Pattern of amputation. | identify how many patients with Diabetic foot underwent amputation, and what type of amputation (major or minor) | 7 years | 
| Mortality among patients with diabetic foot | 7-years mortality rate and predictive variable of death among patients with Diabetic foot. | 7 years |
Breast Lesion Analysis for Tomosynthesis Mammography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

Detailed Description
-----------------
The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (DTM).

Official Title
-----------------
Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions

Conditions
-----------------
Breast Cancer, Abnormal Findings on Radiological Examination of Breast

Intervention / Treatment
-----------------
* Procedure: Computer aided analysis of breast lesions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled for core biopsy of a breast lesion Exclusion Criteria: Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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: A<br>Develop a computer-aided diagnostic system that will aid in the screening and detection of breast abnormalities/cancer | Procedure: Computer aided analysis of breast lesions<br>* Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieve earlier breast cancer detection and characterization |  | 1 year |
Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children

Study Overview
=================
Brief Summary
-----------------
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.

Official Title
-----------------
Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children

Conditions
-----------------
Lung Compliance

Intervention / Treatment
-----------------
* Procedure: Positive end expiratory pressure (PEEP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children undergoing surgery more than 1 hour under general anesthesia American Society Anesthesiologist physical status I, II Exclusion Criteria: History of lung resection History of bronchopulmonary dysplasia or respiratory distress syndrome Abnormalities in chest radiography Laparoscopic surgery Abdominal surgery

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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: Children<br>Children who receive elective surgery under general anesthesia and are supported by mechanical ventilation | Procedure: Positive end expiratory pressure (PEEP)<br>* The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean respiratory compliance | Mean static and dynamic compliance | During 15 minutes after applying each level of PEEP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance profile | We will determine Intratidal compliance-volume profile using the changes in compliance over time --> I, merely increasing compliance profile; IH, increasing turning into horizontal compliance profile; D, merely decreasing compliance profile; HD, horizontal turning into decreasing compliance profile; IHD, increasing turning into horizontal and further turning into decreasing compliance profile If compliance profile is I, the PEEP is low. On the other hand, compliance profile is D, PEEP level is considered to be high. | During 15 minutes after applying each level of PEEP | 
| Airway resistance | Mean airway resistance | During 15 minutes after applying each level of PEEP |
Study for Patients With Non Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Detailed Description
-----------------
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Official Title
-----------------
Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Carboplatin
* Drug: Paclitaxel
* Drug: Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV Exclusion Criteria: New York Heart Association (NYHA) III or IV Brain metastases Neurotoxicity Grade 2 or greater

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carboplatin|nan|
|Drug: Paclitaxel|nan|
|Drug: Vinorelbine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of response rate (stable disease [SD] or better) |  |  | 
| Determination of safety of the combination and life quality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of remission rate |  |  | 
| Determination of time to progression |  |  | 
| Determination of 1-year survival rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
Investigating STAT3 as a Driver of Pathology in Periodontitis

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. This condition is associated with pro-inflammatory mediators that utilize STAT3 as an activator of specific genes related to inflammation and tissue destruction. STAT3 has not been studied in the context of periodontitis in humans. We propose that STAT3 is associated with periodontitis. This knowledge might help to further our understanding of periodontitis pathology

Official Title
-----------------
Investigating STAT3 as a Driver of Pathology and Potential Therapeutic Target in Periodontitis

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-year-old, in good general health, and had no significant medical history. no history of diabetes or other diseases different than periodontitis. Exclusion Criteria: Pregnancy and lactation Use of antibiotics, immunosuppressive agents, or probiotics within 3 months.

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 |
| --- | --- |
| Healthy<br>Subjects without periodontitis | Other: no intervention<br>* no intervention<br>|
| Periodontitis<br>Subjects with periodontitis | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAT3 detection in gingival tissues | Detection of STAT3 in gingival tissues | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, STAT3
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Biological: UB-421
* Other: Antiretroviral (ARV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 seropositive Have a history of at least 6 months on antiretroviral treatment Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening Exclusion Criteria: Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN) Females who are pregnant Any vaccination within 2 weeks prior to the Screening Any prior exposure to UB-421

Ages Eligible for Study
-----------------
Minimum Age: 20 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: UB-421<br>2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). | Biological: UB-421<br>* UB-421 in combination with their ARV<br>Other: Antiretroviral (ARV)<br>* Antiretroviral (ARV)<br>|
| Active Comparator: Placebo<br>2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). | Other: Antiretroviral (ARV)<br>* Antiretroviral (ARV)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV-1 RNA viral load between 2 arms |  | 14 Days |
GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.

Study Overview
=================
Brief Summary
-----------------
The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

Detailed Description
-----------------
The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated. This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.

Official Title
-----------------
GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: High-dose anthracycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 16-60 Diagnosed with previously untreated T-ALL and B-ALL Exclusion Criteria: previously treated ALL patients L3 B-ALL

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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: High-dose anthracycline<br> | Drug: High-dose anthracycline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complete response | Patients are followed-up for response till death |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that reach disease-free-survival | Patients are followed-up for response till death |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL
S8947-9800-9911-0016A Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help doctors identify and learn more biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma.

Detailed Description
-----------------
OBJECTIVES: To evaluate the role of pre-treatment serum 25(OH)D with regard to progression-free survival and objective response among patients with newly diagnosed follicular lymphoma, within the context of a uniformly treated and evaluated Phase III clinical trial in the modern therapeutic era. OUTLINE: This is a multicenter study. Pre-treatment serum samples are analyzed for 25(OH)D levels to determine vitamin D sufficiency or insufficiency.

Official Title
-----------------
Vitamin D Insufficiency and Follicular Lymphoma Prognosis

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Newly diagnosed CD20+ follicular lymphoma Enrolled on clinical trial SWOG-S0016, SWOG-9800, or SWOG-9911 Pre-treatment serum available through SWOG-8947 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

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: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | retrospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response (confirmed and unconfirmed complete and partial responses) |  | retrospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA. The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

Conditions
-----------------
Uterine Fibroids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA. Exclusion Criteria: Patient is pregnant or plans to become pregnant in the next 3 months, Patient is breastfeeding, Patient has genital bleeding of unknown etiology or not due to uterine fibroids, Patient has been diagnosed with uterine, cervical, ovarian or breast cancer, Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment, Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients

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 |
| --- | --- |
| Patients treated with Esmya<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation. |  | Patients will be followed from baseline up to 15 months |