linjc16/ctgov huggingface dataset:
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

Study Overview
=================
Brief Summary
-----------------
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

Official Title
-----------------
An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival Male or female outpatient 20 years of age and older Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test Exclusion Criteria: Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study Treated with montelukast within 3 months before enrollment Unable to perform acceptable, reproducible spirometry and peak flow measurement Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptoms score throughout the study |  |  |
CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

Detailed Description
-----------------
OBJECTIVES: Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma. Determine the clinical toxic effects of this drug in these patients. OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Official Title
-----------------
Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Drug: CP4071


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed soft tissue sarcoma Metastatic or locally advanced Failed at least 1 prior therapy Measurable disease outside prior irradiation field No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Calcium less than ULN Potassium normal Other: No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier therapy allowed Chemotherapy: No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: No other concurrent cardiac glycosides

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP4071|nan|

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
-----------------
stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

Study Overview
=================
Brief Summary
-----------------
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

Detailed Description
-----------------
To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.

Official Title
-----------------
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.

Conditions
-----------------
Renal Stones, Nephrolithiasis

Intervention / Treatment
-----------------
* Drug: Tranexamic acid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 18 years or older Stones ≥ 2 cm and/or mild to moderate hydronephrosis. Exclusion Criteria: Age <18 years or Pregnancy Bilateral simultaneous PCNL Morbid obesity (BMI >40) Refuse to complete study requirements Untreated UTI Atypical bowel interposition by CT Tumour in the presumptive access tract area or Potential malignant kidney tumour

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: tranexamic acid during and after percutanous nephrolithotomy procedure
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid local<br>tranexamic acid inside the irrigation fluid | Drug: Tranexamic acid injection<br>* hemostatics use<br>* Other names: tranexamic acid 500 mg;|
| Active Comparator: tranexamic acid IV<br>tranexamic acid injection | Drug: Tranexamic acid injection<br>* hemostatics use<br>* Other names: tranexamic acid 500 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the value of tranexamic acid | To compare the efficacy and safety of 0.1% IV tranexamic acid versus inside the irrigant fluid tranexamic acid in reducing blood loss during PCNL. Moreover, to assess the adverse events of tranexamic acid. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin drop post PCNL. | Assess fall percentage in hemoglobin drop. | 12 months | 
| Requirement of blood transfusion post PCNL. | assess the total blood loss and requirement of blood transfusion post PCNL. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tranexamic acid, percutanous nephrolithotomy
Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

Study Overview
=================
Brief Summary
-----------------
In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.

Official Title
-----------------
Prospective Study on the Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Biological: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been informed about the study Patients over 18 years patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent Exclusion Criteria: Adults under guardianship Patients without national health insurance cover Pregnant or breast-feeding women allografts and autografts of Haematopoietic Stem Cells (HSC)

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fongitell test<br> | Biological: blood samples<br> <br> |
| Active Comparator: serum galactomannan<br> | Biological: blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value |  | 8 to 10 assays over 4 to 5 weeks of hospitalization |
Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
This study adds to the understanding of the contributing factors leading to LARS, the long term effects of this syndrome post-operatively and its impact on quality of life.

Official Title
-----------------
Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study

Conditions
-----------------
Low Anterior Resection Syndrome, Cancer, Quality of Life

Intervention / Treatment
-----------------
* Procedure: anterior resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients >18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016 Exclusion Criteria: colorectal cancer (>15cm) from anal verge permanent stoma known disseminated or recurrent disease, patient without restitution of bowel continuity after 1 year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LARS symptoms<br>Patient suffering from LARS as identified through LARS questionnaire | Procedure: anterior resection<br>* The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed<br>* Other names: radiotherapy +/- chemotherapy;|
| No LARS symptoms<br>Absence of LARS symptoms | Procedure: anterior resection<br>* The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed<br>* Other names: radiotherapy +/- chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LARS incidence | Incidence of LARS in patients who had anterior resection | 1 year | 
| Risk factors | Variable factors which might have contributed to LARS were the following: Age Gender Diabetes mellitus Pathological stage MRI stage Distance from anal verge Surgical technique Preoperative radiotherapy Preoperative chemotherapy Postoperative radio/chemotherapy Type of anastomosis Presence of stoma Interval from stoma reversal Duration of follow-up | 1 year | 
| Life | The association between LARS and quality of life was assessed. | 1 year |
Somatosensory Tinnitus Study

Study Overview
=================
Brief Summary
-----------------
Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

Detailed Description
-----------------
Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population. Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus). Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A. Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Official Title
-----------------
A New Therapeutic Approach for Somatosensory Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Other: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veteran chronic tinnitus positive screen for somatosensory tinnitus Exclusion Criteria: Non-Veteran participation in new (< 1 month) tinnitus management or treatment current participation in tinnitus research involving an intervention
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: Individualized Physiotherapy<br>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy. | Other: Physical Therapy<br>* Individualized physiotherapy including exercises to be performed by the Veteran at home.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index | The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem). | Baseline and 1 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus
Role of Positive Affect in Adjustment to HIV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the role of emotion and mood in the context of HIV.

Detailed Description
-----------------
A growing body of literature indicates that positive affect may have a unique adaptive role in the process of adjustment to chronic stress, independent of the effects of negative affects like depression. The overarching goal of this research is to provide evidence and direction for the development of interventions for people with HIV that include a focus on positive affect. To this end, this study will document the occurrence, predictors, and consequences of positive affect during the 18 months post-notification of HIV+ serostatus.

Official Title
-----------------
CHAI Study: Coping, HIV, and Affect Interview Study

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been informed they were HIV positive within the past two months Speak English Be 18 years or older Have the ability to provide informed consent to be a research participant Exclusion Criteria: Severe cognitive impairment Active psychosis

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 |
| --- | --- | --- |
| Well being |  | 18 month follow-up | 
| Physical & Mental Health |  | 18 months | 
| Coping Response |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, coping, emotion, affect, HIV infection, Complimentary therapies
Cervical Cancer in French Guiana: Screening Between 2006-2011

Study Overview
=================
Brief Summary
-----------------
Given that cervical cancer is the second most frequent cancer among women in french guiana the aim of the study was to determine the screening rate among women living in French Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years. between 2006 and 2011 54% of women were screened. These baseline figures will allow to evaluate present efforts to increase the screening rate for this frequent cancer in French Guiana.

Official Title
-----------------
Cervical Cancer in French Guiana: Screening Between 2006-2011. Description of the Population With Invasive Cervical Cancer Between 2003-2008

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: cross sectional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women screened Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cross sectional|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical cancer screening | Cytological examination screens for neoplasic lesion according to the Bethsda 2001, results are assessed on a yearly basis to obtain annual screening rates relative to the female population. | 1 year (screening that year) |
Observational Study of Corneal Opacities in Adults

Study Overview
=================
Brief Summary
-----------------
A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.

Official Title
-----------------
Observational Study of Corneal Opacities in Adults

Conditions
-----------------
Corneal Opacities (Scar and Stromal Dystrophy)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult (18 & older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy) Exclusion Criteria: Inability to give informed consent. Inability to maintain stable fixation for OCT imaging. Inability to commit to required visits to complete the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| corneal opacities<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of suitable subjects | The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate OCT topography | A second goal is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography and develop a mathematical model that relates epithelial thickness variation to corneal mean curvature. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corneal opacities, Optical coherence tomography